PET-Directed Therapy in Treating Patients with Limited-Stage Diffuse Large B-Cell Lymphoma

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IIBiomarker/Laboratory analysis, Treatment18 and overS1001
NCI-2011-02673, CDR0000700624, SWOG-S1001, NCT01359592

Trial Description

Summary

This phase II trial studies how well positron emission tomography (PET)-directed chemotherapy works in treating patients with limited-stage diffuse large B-cell lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill cancer cells. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radio labeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Comparing results of diagnostic procedures, such as PET scan and computed tomography (CT) scan, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.

Further Study Information

PRIMARY OBJECTIVE:

I. To assess the 5-year progression-free survival (PFS) rate in patients with newly diagnosed limited-stage diffuse, large B-cell lymphoma (DLBCL) using PET/CT scan to direct therapy after 3 cycles of rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (R-CHOP).

SECONDARY OBJECTIVES:

I. To evaluate progression-free survival within the PET-positive (+) and PET-negative (-) subgroups of patients with newly diagnosed limited-stage diffuse large B-cell lymphoma (DLBCL).

II. To evaluate toxicity of the protocol treatments in this patient population.

III. To evaluate the response probability in this patient population.

IV. To evaluate overall survival in the overall population, and within the PET+ and PET- subgroups.

V. To estimate the rate of upstaging at baseline by PET/CT among patients newly diagnosed with limited-stage diffuse large B-cell lymphoma by CT imaging and describe outcomes in patients upstaged by PET/CT at baseline to advanced DLBCL.

VI. To describe outcomes in the subgroup of patients upstaged by PET/CT.

VII. To evaluate the association of germinal center B-cell subtype (GCB) vs stromal-1 vs stromal-2 gene expression signatures with PFS or overall survival (OS).

OUTLINE:

CHEMOTHERAPY: Patients receive R-CHOP comprising rituximab intravenously (IV), cyclophosphamide IV over 30-60 minutes, vincristine sulfate IV, and doxorubicin hydrochloride IV on day 1, and prednisone orally (PO) on days 1-5. Treatment repeats every 21 days for 3* courses.

NOTE: *Patients found to have advanced stage DLBCL based on local review of the baseline PET scan receive 6 courses of R-CHOP.

RADIOTHERAPY: Patients with complete response (PET scan negative) receive one additional course of R-CHOP as above. Patients with partial response (PET scan positive) undergo involved-field radiotherapy (IFRT) 5 days a week for approximately 4-5 weeks.

MONOCLONAL ANTIBODY: Beginning 3-6 weeks after completion of IFRT, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 7, 8 or 9 and rituximab IV on day 1 and then 7, 8, or 9.

After completion of study treatment, patients are followed up every 6 months for 2 years and then annually for 7 years.

Eligibility Criteria

Inclusion Criteria:

The lymphoma must express the cluster of differentiation (CD)20 antigen by either flow cytometry using anti-CD20 antibodies or by immunoperoxidase staining of paraffin sections; a report providing confirmation of CD20 expression must be submitted

Zubrod performance status 0-2

The following tests must be performed within 42 days prior to registration either for diagnosis/staging or to obtain baseline values:

White blood cells (WBC)

Hemoglobin

Lactate dehydrogenase (LDH)

Hepatitis B-surface antigen (Ag) and anti-core antibody (Ab)

Serum creatinine =< 2 x institutional upper limit of normal (IULN), unless due to lymphoma, within 42 day prior to registration

Platelet count >= 100,000 cells/mcL

Absolute neutrophil count (ANC) >= 1,000 cells/mcL within 42 days prior to registration

As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

SECOND REGISTRATION (STEP 2)

Patients must not be known to be human immunodeficiency virus (HIV)-positive

No other prior malignancy is allowed except for the following:

Adequately treated in situ cancers (stage 0)

Adequately treated basal cell or squamous cell skin cancer

Adequately treated stage I or II cancer from which the patient has been in complete remission or

Any other cancer from which the patient has been disease-free for at least 5 years

Patients must have non-bulky stage I or II disease by Ann Arbor classification

This staging excludes fludeoxyglucose F 18 (FDG)-PET evaluation

Patients who have stage I or II non-bulky disease based on diagnostic CT scan, but are upstaged to stage III or IV based on FDG-PET evaluation, are also eligible

Stage and bulk are assigned using measurements obtained prior to biopsy

Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method during the study period; a woman is considered to be "of reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures

Patients must have a complete history and physical examination within 28 days prior to registration

Patients must have either measurable or evaluable limited-stage DLBCL

Patients rendered free of measurable or evaluable disease by virtue of biopsy (resection) are also eligible; NOTE: if patient has measurable disease it must be documented on the Lymphoma Baseline Tumor Assessment Form

All measurable disease must be assessed within 28 days prior to registration

Patients with non-measurable disease with or without measurable disease must have all non-measurable disease assessed within 42 days prior to registration

Patients must have biopsy-proven de-novo diffuse large B-cell lymphoma (DLBCL)

Patients with primary mediastinal lymphoma or testicular lymphoma are not eligible

Patients with prior or simultaneous diagnosis of indolent lymphoma are not eligible

Post-transplant lymphoproliferative disorder with DLBCL morphology is ineligible

Adequate sections or a paraffin block from the original diagnostic specimen must be submitted for review by the lymphoma pathology group

If PET-negative based on the returned results from centralized review, patients must be planning to begin further treatment within 35 days of the start of cycle 3 of R-CHOP; if PET-positive based on the returned results from centralized review, it is important for patients to start IFRT as soon as possible after the end of cycle 3 of R-CHOP; they should be planning to initiate IFRT followed by yttrium-90 ibritumomab tiuxetan within 35 days of the start of cycle 3 of R-CHOP

Patients must not have clinical evidence of central nervous system (CNS) involvement by lymphoma

Any laboratory or radiographic tests performed to assess CNS involvement must be negative and must be performed within 42 days prior to registration

Patients must have a unilateral or bilateral bone marrow biopsy performed within 42 days prior to registration

Patients must be offered the opportunity to consent to the use of specimens for future research

Patients must have a diagnostic quality contrast-enhanced CT scan of the chest, abdomen, and pelvis AND baseline FDG-PET scan performed within 28 days prior to registration

Low-resolution "localization" CT scans performed as part of a combined PET/CT scan are not adequate for enrollment or response determination on this protocol

If a patient has an allergy to CT contrast, then a non-enhanced CT will be acceptable

Interim PET/CT scans must have been submitted for centralized review

Patients must have completed 3 cycles of R-CHOP with no evidence of disease progression

Patients must have a cardiac ejection fraction >= institutional lower limit of normal (ILLN) by multi gated acquisition (MUGA) scan or 2-dimensional (D) echocardiogram (ECHO) within 42 days prior to registration

Patients must have aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 5 x IULN, unless due to lymphoma, within 42 days prior to registration

Total bilirubin =< 2 x institutional upper limit of normal (IULN) (unless due to Gilbert syndrome) within 42 days prior to registration

Patients must not have received prior chemotherapy, radiotherapy, or antibody therapy for lymphoma

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Southwest Oncology Group (SWOG) Research Base

  • National Cancer Institute
Daniel O. Persky, Principal Investigator

Trial Sites

U.S.A.

Alaska
Anchorage

Alaska Breast Care and Surgery LLC

Keith S. Lanier
Ph: 503-215-6412

Keith S. Lanier
Principal Investigator

Alaska Women's Cancer Care

Keith S. Lanier
Ph: 503-215-6412

Keith S. Lanier
Principal Investigator

Anchorage Oncology Centre

Keith S. Lanier
Ph: 503-215-6412

Keith S. Lanier
Principal Investigator

Katmai Oncology Group

Keith S. Lanier
Ph: 503-215-6412

Keith S. Lanier
Principal Investigator

Providence Alaska Medical Center

Keith S. Lanier
Ph: 503-215-6412

Keith S. Lanier
Principal Investigator

Fairbanks

Fairbanks Memorial Hospital

Prakash Vishnu
Ph: 206-342-6954
Email: vmmc.cancer_clinical_research@VirginiaMason.org

Prakash Vishnu
Principal Investigator

Arizona
Tucson

The University of Arizona Cancer Center-North Campus

Thomas P. Miller
Ph: 520-626-9008

Thomas P. Miller
Principal Investigator

The University of Arizona Medical Center-University Campus

Thomas P. Miller
Ph: 520-626-9008

Thomas P. Miller
Principal Investigator

California
Burbank

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Keith S. Lanier
Ph: 503-215-6412

Keith S. Lanier
Principal Investigator

Duarte

City of Hope Comprehensive Cancer Center

Robert W. Chen
Ph: 800-826-4673
Email: becomingapatient@coh.org

Robert W. Chen
Principal Investigator

Connecticut
Hartford

Saint Francis Hospital and Medical Center

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

New Haven

Yale University

Iris Isufi
Ph: 203-785-5702

Iris Isufi
Principal Investigator

Georgia
Atlanta

Atlanta Regional CCOP

Thomas Edwin Seay
Ph: 404-303-3355

Thomas Edwin Seay
Principal Investigator

Northside Hospital

Thomas Edwin Seay
Ph: 404-303-3355

Thomas Edwin Seay
Principal Investigator

Piedmont Hospital

Thomas Edwin Seay
Ph: 404-303-3355

Thomas Edwin Seay
Principal Investigator

Saint Joseph's Hospital of Atlanta

Thomas Edwin Seay
Ph: 404-303-3355

Thomas Edwin Seay
Principal Investigator

Austell

Well Star Cobb Hospital

Thomas Edwin Seay
Ph: 404-303-3355

Thomas Edwin Seay
Principal Investigator

Columbus

John B Amos Cancer Center

Thomas Edwin Seay
Ph: 404-303-3355

Thomas Edwin Seay
Principal Investigator

Decatur

Dekalb Medical Center

Thomas Edwin Seay
Ph: 404-303-3355

Thomas Edwin Seay
Principal Investigator

Fayetteville

Piedmont Fayette Hospital

Thomas Edwin Seay
Ph: 404-303-3355

Thomas Edwin Seay
Principal Investigator

Lawrenceville

Gwinnett Medical Center

Thomas Edwin Seay
Ph: 404-303-3355

Thomas Edwin Seay
Principal Investigator

Marietta

Wellstar Kennestone Hospital

Thomas Edwin Seay
Ph: 404-303-3355

Thomas Edwin Seay
Principal Investigator

Riverdale

Southern Regional Medical Center

Thomas Edwin Seay
Ph: 404-303-3355

Thomas Edwin Seay
Principal Investigator

Rome

Harbin Clinic Medical Oncology and Clinical Research

Thomas Edwin Seay
Ph: 404-303-3355

Thomas Edwin Seay
Principal Investigator

Hawaii
Aiea

Oncare Hawaii Inc-Pali Momi

Jeffrey L. Berenberg
Ph: 808-586-2979

Jeffrey L. Berenberg
Principal Investigator

Pali Momi Medical Center

Jeffrey L. Berenberg
Ph: 808-586-2979

Jeffrey L. Berenberg
Principal Investigator

Ewa Beach

The Cancer Center of Hawaii-Leeward

Jeffrey L. Berenberg
Ph: 808-586-2979

Jeffrey L. Berenberg
Principal Investigator

Honolulu

Kapiolani Medical Center for Women and Children

Jeffrey L. Berenberg
Ph: 808-586-2979

Jeffrey L. Berenberg
Principal Investigator

Kuakini Medical Center

Jeffrey L. Berenberg
Ph: 808-586-2979

Jeffrey L. Berenberg
Principal Investigator

Oncare Hawaii Inc-Kuakini

Jeffrey L. Berenberg
Ph: 808-586-2979

Jeffrey L. Berenberg
Principal Investigator

Oncare Hawaii Inc-POB II

Jeffrey L. Berenberg
Ph: 808-586-2979

Jeffrey L. Berenberg
Principal Investigator

OnCare Hawaii-Liliha

Jeffrey L. Berenberg
Ph: 808-586-2979

Jeffrey L. Berenberg
Principal Investigator

Queen's Medical Center

Jeffrey L. Berenberg
Ph: 808-586-2979

Jeffrey L. Berenberg
Principal Investigator

Straub Clinic and Hospital

Jeffrey L. Berenberg
Ph: 808-586-2979

Jeffrey L. Berenberg
Principal Investigator

The Cancer Center of Hawaii-Liliha

Jeffrey L. Berenberg
Ph: 808-586-2979

Jeffrey L. Berenberg
Principal Investigator

University of Hawaii Cancer Center

Jeffrey L. Berenberg
Ph: 808-586-2979

Jeffrey L. Berenberg
Principal Investigator

Lihue

Wilcox Memorial Hospital and Kauai Medical Clinic

Jeffrey L. Berenberg
Ph: 808-586-2979

Jeffrey L. Berenberg
Principal Investigator

Idaho
Boise

Saint Alphonsus Cancer Care Center-Boise

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Coeur D'Alene

Kootenai Medical Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Fruitland

Saint Luke's Mountain States Tumor Institute - Fruitland

Paul G. Montgomery
Ph: 800-845-4624

Paul G. Montgomery
Principal Investigator

Meridian

Saint Luke's Mountain States Tumor Institute - Meridian

Paul G. Montgomery
Ph: 800-845-4624

Paul G. Montgomery
Principal Investigator

Nampa

Saint Luke's Mountain States Tumor Institute - Nampa

Paul G. Montgomery
Ph: 800-845-4624

Paul G. Montgomery
Principal Investigator

Post Falls

Kootenai Cancer Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Sandpoint

Kootenai Cancer

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Twin Falls

Saint Luke's Mountain States Tumor Institute-Twin Falls

Paul G. Montgomery
Ph: 800-845-4624

Paul G. Montgomery
Principal Investigator

Illinois
Bloomington

Illinois CancerCare-Bloomington

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Saint Joseph Medical Center

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Canton

Illinois CancerCare-Canton

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Carbondale

Memorial Hospital of Carbondale

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Carthage

Illinois CancerCare-Carthage

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Centralia

Centralia Oncology Clinic

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Chicago

Northwestern University

Adam Matthew Petrich
Ph: 312-695-1301
Email: cancer@northwestern.edu

Adam Matthew Petrich
Principal Investigator

Weiss Memorial Hospital

Stuart A. Krauss
Ph: 773-564-5044

Stuart A. Krauss
Principal Investigator

Decatur

Cancer Care Center of Decatur

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Decatur Memorial Hospital

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Effingham

Crossroads Cancer Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Eureka

Illinois CancerCare-Eureka

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Evanston

NorthShore University HealthSystem-Evanston Hospital

David L. Grinblatt
Ph: 847-570-2109

David L. Grinblatt
Principal Investigator

Galesburg

Illinois CancerCare Galesburg

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Illinois CancerCare-Galesburg Cottage Plaza Office

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Western Illinois Cancer Treatment Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Glenview

NorthShore University HealthSystem-Glenbrook Hospital

David L. Grinblatt
Ph: 847-570-2109

David L. Grinblatt
Principal Investigator

Highland Park

Hematology Oncology Associates of Illinois-Highland Park

Adam Matthew Petrich
Ph: 312-695-1301
Email: cancer@northwestern.edu

Adam Matthew Petrich
Principal Investigator

NorthShore University HealthSystem-Highland Park Hospital

David L. Grinblatt
Ph: 847-570-2109

David L. Grinblatt
Principal Investigator

Kankakee

Presence Saint Mary's Hospital

Adam Matthew Petrich
Ph: 312-695-1301
Email: cancer@northwestern.edu

Adam Matthew Petrich
Principal Investigator

Kewanee

Illinois CancerCare-Kewanee Clinic

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Libertyville

North Shore Hematology Oncology

Adam Matthew Petrich
Ph: 312-695-1301
Email: cancer@northwestern.edu

Adam Matthew Petrich
Principal Investigator

Macomb

Illinois CancerCare-Macomb

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Maywood

Loyola University Medical Center

Scott Edward Smith
Ph: 708-226-4357

Scott Edward Smith
Principal Investigator

Niles

Illinois Cancer Specialists-Niles

Adam Matthew Petrich
Ph: 312-695-1301
Email: cancer@northwestern.edu

Adam Matthew Petrich
Principal Investigator

Ottawa

Illinois CancerCare-Ottawa Clinic

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Radiation Oncology of Northern Illinois

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Pekin

Illinois CancerCare-Pekin

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Pekin Cancer Treatment Center

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Peoria

Illinois CancerCare-Peoria

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Methodist Medical Center of Illinois

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

OSF Saint Francis Medical Center

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Peru

Illinois CancerCare-Peru

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Valley Radiation Oncology

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Princeton

Illinois CancerCare-Princeton

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Skokie

Hematology Oncology Associates of Illinois - Skokie

Adam Matthew Petrich
Ph: 312-695-1301
Email: cancer@northwestern.edu

Adam Matthew Petrich
Principal Investigator

Springfield

Central Illinois Hematology Oncology Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Memorial Medical Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Southern Illinois University School of Medicine

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Springfield Clinic

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Swansea

Cancer Care Specialists of Illinois-Swansea

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Iowa
Sioux City

Siouxland Regional Cancer Center

Donald B. Wender
Ph: 712-252-0088

Donald B. Wender
Principal Investigator

Kansas
Chanute

Cancer Center of Kansas - Chanute

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Dodge City

Cancer Center of Kansas - Dodge City

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

El Dorado

Cancer Center of Kansas - El Dorado

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Fort Scott

Cancer Center of Kansas - Fort Scott

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Independence

Cancer Center of Kansas-Independence

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Kingman

Cancer Center of Kansas-Kingman

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Lawrence

Lawrence Memorial Hospital

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Liberal

Cancer Center of Kansas-Liberal

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Newton

Cancer Center of Kansas - Newton

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Overland Park

Menorah Medical Center

Rakesh Gaur
Ph: 913-948-5588
Email: aroland@kccop.org

Rakesh Gaur
Principal Investigator

Saint Luke's South Hospital

Rakesh Gaur
Ph: 913-948-5588
Email: aroland@kccop.org

Rakesh Gaur
Principal Investigator

Parsons

Cancer Center of Kansas - Parsons

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Pratt

Cancer Center of Kansas - Pratt

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Salina

Cancer Center of Kansas - Salina

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Wellington

Cancer Center of Kansas - Wellington

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Wichita

Associates In Womens Health

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Cancer Center of Kansas - Main Office

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Cancer Center of Kansas-Wichita Medical Arts Tower

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Via Christi Regional Medical Center

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Winfield

Cancer Center of Kansas - Winfield

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Kentucky
Lexington

University of Kentucky/Markey Cancer Center

Gregory P. Monohan
Ph: 859-257-3379

Gregory P. Monohan
Principal Investigator

Maryland
Baltimore

Sinai Hospital of Baltimore

Roberto F. Martinez
Ph: 410-601-6120
Email: pridgely@lifebridgehealth.org

Roberto F. Martinez
Principal Investigator

Michigan
Ann Arbor

Saint Joseph Mercy Hospital

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Dearborn

Oakwood Hospital and Medical Center

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Detroit

Saint John Hospital and Medical Center

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Flint

Genesys Hurley Cancer Institute

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Hurley Medical Center

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Jackson

Allegiance Health

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Lansing

Sparrow Hospital

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Livonia

Saint Mary Mercy Hospital

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Pontiac

Saint Joseph Mercy Oakland

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Port Huron

Saint Joseph Mercy Port Huron

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Saginaw

Saint Mary's of Michigan

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Warren

Saint John Macomb-Oakland Hospital

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Minnesota
Burnsville

Fairview Ridges Hospital

Patrick James Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Patrick James Flynn
Principal Investigator

Coon Rapids

Mercy Hospital

Patrick James Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Patrick James Flynn
Principal Investigator

Duluth

Essentia Health Cancer Center

Bret E.B. Friday
Ph: 888-203-7267

Bret E.B. Friday
Principal Investigator

Essentia Health Saint Mary's Medical Center

Daniel A. Nikcevich
Ph: 888-203-7267

Daniel A. Nikcevich
Principal Investigator

Miller-Dwan Hospital

Daniel A. Nikcevich
Ph: 888-203-7267

Daniel A. Nikcevich
Principal Investigator

Edina

Fairview-Southdale Hospital

Patrick James Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Patrick James Flynn
Principal Investigator

Fridley

Unity Hospital

Patrick James Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Patrick James Flynn
Principal Investigator

Hutchinson

Hutchinson Area Health Care

Patrick James Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Patrick James Flynn
Principal Investigator

Maplewood

Minnesota Oncology Hematology PA-Maplewood

Patrick James Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Patrick James Flynn
Principal Investigator

Saint John's Hospital - Healtheast

Patrick James Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Patrick James Flynn
Principal Investigator

Minneapolis

Abbott-Northwestern Hospital

Patrick James Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Patrick James Flynn
Principal Investigator

Health Partners Inc

Patrick James Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Patrick James Flynn
Principal Investigator

Hennepin County Medical Center

Patrick James Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Patrick James Flynn
Principal Investigator

New Ulm

New Ulm Medical Center

Patrick James Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Patrick James Flynn
Principal Investigator

Robbinsdale

North Memorial Medical Health Center

Patrick James Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Patrick James Flynn
Principal Investigator

Saint Louis Park

Park Nicollet Clinic - Saint Louis Park

Patrick James Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Patrick James Flynn
Principal Investigator

Saint Paul

Regions Hospital

Patrick James Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Patrick James Flynn
Principal Investigator

United Hospital

Patrick James Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Patrick James Flynn
Principal Investigator

Shakopee

Saint Francis Regional Medical Center

Patrick James Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Patrick James Flynn
Principal Investigator

Stillwater

Lakeview Hospital

Patrick James Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Patrick James Flynn
Principal Investigator

Waconia

Ridgeview Medical Center

Patrick James Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Patrick James Flynn
Principal Investigator

Willmar

Rice Memorial Hospital

Patrick James Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Patrick James Flynn
Principal Investigator

Woodbury

Minnesota Oncology and Hematology PA-Woodbury

Patrick James Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Patrick James Flynn
Principal Investigator

Missouri
Bonne Terre

Parkland Health Center-Bonne Terre

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Cape Girardeau

Saint Francis Medical Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Southeast Cancer Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Independence

Centerpoint Medical Center LLC

Rakesh Gaur
Ph: 913-948-5588
Email: aroland@kccop.org

Rakesh Gaur
Principal Investigator

Jefferson City

Capital Region Medical Center-Goldschmidt Cancer Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Kansas City

Heartland Hematology and Oncology Associates Incorporated

Rakesh Gaur
Ph: 913-948-5588
Email: aroland@kccop.org

Rakesh Gaur
Principal Investigator

Research Medical Center

Rakesh Gaur
Ph: 913-948-5588
Email: aroland@kccop.org

Rakesh Gaur
Principal Investigator

Saint Luke's Hospital of Kansas City

Rakesh Gaur
Ph: 913-948-5588
Email: aroland@kccop.org

Rakesh Gaur
Principal Investigator

Lee's Summit

Saint Luke's East - Lee's Summit

Rakesh Gaur
Ph: 913-948-5588
Email: aroland@kccop.org

Rakesh Gaur
Principal Investigator

Liberty

Liberty Radiation Oncology Center

Rakesh Gaur
Ph: 913-948-5588
Email: aroland@kccop.org

Rakesh Gaur
Principal Investigator

Saint Joseph

Heartland Regional Medical Center

Rakesh Gaur
Ph: 913-948-5588
Email: aroland@kccop.org

Rakesh Gaur
Principal Investigator

Saint Louis

Missouri Baptist Medical Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Washington University School of Medicine

Nancy L. Bartlett
Ph: 800-600-3606
Email: info@siteman.wustl.edu

Nancy L. Bartlett
Principal Investigator

Sainte Genevieve

Sainte Genevieve County Memorial Hospital

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Sullivan

Missouri Baptist Sullivan Hospital

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Sunset Hills

Missouri Baptist Outpatient Center-Sunset Hills

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Montana
Billings

Billings Clinic Cancer Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Montana Cancer Consortium CCOP

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Saint Vincent Healthcare

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Bozeman

Bozeman Deaconess Hospital

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Butte

Saint James Community Hospital and Cancer Treatment Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Great Falls

Benefis Healthcare- Sletten Cancer Institute

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Helena

Saint Peter's Community Hospital

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Kalispell

Kalispell Regional Medical Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Missoula

Community Medical Hospital

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Saint Patrick Hospital - Community Hospital

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

New Hampshire
Portsmouth

Portsmouth Regional Hospital

Christine Wasilewski
Ph: 603-433-5226

Christine Wasilewski
Principal Investigator

New York
Middletown

Orange Regional Medical Center

Jeffrey M. Stewart
Ph: 845-342-7609

Jeffrey M. Stewart
Principal Investigator

Rochester

University of Rochester

Jonathan Willmann Friedberg
Ph: 585-275-5830

Jonathan Willmann Friedberg
Principal Investigator

North Carolina
Chapel Hill

University of North Carolina at Chapel Hill

Steven I. Park
Ph: 877-668-0683
Email: cancerclinicaltrials@med.unc.edu

Steven I. Park
Principal Investigator

Goldsboro

Wayne Memorial Hospital

James N. Atkins
Ph: 919-580-0000

James N. Atkins
Principal Investigator

Hendersonville

Park Ridge Hospital Breast Health Center

James Dewitt Bearden
Ph: 800-486-5941

James Dewitt Bearden
Principal Investigator

Raleigh

Rex Cancer Center

Jeffrey Major Crane
Ph: 919-784-7209

Jeffrey Major Crane
Principal Investigator

Statesville

Iredell Memorial Hospital

Ruby Ann Grimm
Ph: 704-873-5661

Ruby Ann Grimm
Principal Investigator

North Dakota
Fargo

Roger Maris Cancer Center

Preston D. Steen
Ph: 701-234-6161

Preston D. Steen
Principal Investigator

Sanford Clinic North-Fargo

Preston D. Steen
Ph: 701-234-6161

Preston D. Steen
Principal Investigator

Sanford Medical Center-Fargo

Preston D. Steen
Ph: 701-234-6161

Preston D. Steen
Principal Investigator

Ohio
Canton

Mercy Medical Center

Mitchell Haut
Ph: 888-293-4673

Mitchell Haut
Principal Investigator

Oregon
Clackamas

Clackamas Radiation Oncology Center

Keith S. Lanier
Ph: 503-215-6412

Keith S. Lanier
Principal Investigator

Providence Oncology and Hematology Care Southeast

Keith S. Lanier
Ph: 503-215-6412

Keith S. Lanier
Principal Investigator

Newberg

Providence Newberg Medical Center

Keith S. Lanier
Ph: 503-215-6412

Keith S. Lanier
Principal Investigator

Oregon City

Providence Willamette Falls Medical Center

Keith S. Lanier
Ph: 503-215-6412

Keith S. Lanier
Principal Investigator

Portland

Providence Portland Medical Center

Keith S. Lanier
Ph: 503-215-6412

Keith S. Lanier
Principal Investigator

Providence Saint Vincent Medical Center

Keith S. Lanier
Ph: 503-215-6412

Keith S. Lanier
Principal Investigator

Pennsylvania
Danville

Geisinger Medical Center

Edward J. Gorak
Ph: 570-271-5251

Edward J. Gorak
Principal Investigator

Hazleton

Geisinger Medical Center-Cancer Center Hazleton

Edward J. Gorak
Ph: 570-271-5251

Edward J. Gorak
Principal Investigator

Philadelphia

Fox Chase Cancer Center

Stefan Klaus Barta
Ph: 215-728-4790

Stefan Klaus Barta
Principal Investigator

Temple University Hospital

Stefan Klaus Barta
Ph: 215-728-4790

Stefan Klaus Barta
Principal Investigator

South Carolina
Greenville

Greenville Health System Cancer Institute-Butternut

Jeffrey K. Giguere
Ph: 864-241-6251

Jeffrey K. Giguere
Principal Investigator

Greenville Health System Cancer Institute-Eastside

Jeffrey K. Giguere
Ph: 864-241-6251

Jeffrey K. Giguere
Principal Investigator

Greenville Health System Cancer Institute-Faris

Jeffrey K. Giguere
Ph: 864-241-6251

Jeffrey K. Giguere
Principal Investigator

Greenville Memorial Hospital

Jeffrey K. Giguere
Ph: 864-241-6251

Jeffrey K. Giguere
Principal Investigator

Saint Francis Cancer Center

James Dewitt Bearden
Ph: 800-486-5941

James Dewitt Bearden
Principal Investigator

Saint Francis Hospital

James Dewitt Bearden
Ph: 800-486-5941

James Dewitt Bearden
Principal Investigator

Greer

Greenville Health System Cancer Institute-Greer

Jeffrey K. Giguere
Ph: 864-241-6251

Jeffrey K. Giguere
Principal Investigator

Seneca

Greenville Health System Cancer Institute-Seneca

Jeffrey K. Giguere
Ph: 864-241-6251

Jeffrey K. Giguere
Principal Investigator

Spartanburg

Greenville Health System Cancer Institute-Spartanburg

Jeffrey K. Giguere
Ph: 864-241-6251

Jeffrey K. Giguere
Principal Investigator

Spartanburg Medical Center

James Dewitt Bearden
Ph: 800-486-5941

James Dewitt Bearden
Principal Investigator

South Dakota
Sioux Falls

Sanford Cancer Center-Oncology Clinic

Preston D. Steen
Ph: 701-234-6161

Preston D. Steen
Principal Investigator

Sanford USD Medical Center - Sioux Falls

Preston D. Steen
Ph: 701-234-6161

Preston D. Steen
Principal Investigator

Washington
Kirkland

Seattle Cancer Care Alliance at EvergreenHealth

Oliver W. Press
Ph: 800-422-6237

Oliver W. Press
Principal Investigator

Longview

Saint John Medical Center

Keith S. Lanier
Ph: 503-215-6412

Keith S. Lanier
Principal Investigator

Seattle

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Oliver W. Press
Ph: 800-422-6237

Oliver W. Press
Principal Investigator

Pacific Medical Center-First Hill

Prakash Vishnu
Ph: 206-342-6954
Email: vmmc.cancer_clinical_research@VirginiaMason.org

Prakash Vishnu
Principal Investigator

Seattle Cancer Care Alliance

Oliver W. Press
Ph: 800-422-6237

Oliver W. Press
Principal Investigator

University of Washington Medical Center

Oliver W. Press
Ph: 800-422-6237

Oliver W. Press
Principal Investigator

Virginia Mason CCOP

Prakash Vishnu
Ph: 206-342-6954
Email: vmmc.cancer_clinical_research@VirginiaMason.org

Prakash Vishnu
Principal Investigator

Virginia Mason Medical Center

Prakash Vishnu
Ph: 206-342-6954
Email: vmmc.cancer_clinical_research@VirginiaMason.org

Prakash Vishnu
Principal Investigator

Vancouver

PeaceHealth Southwest Medical Center

Keith S. Lanier
Ph: 503-215-6412

Keith S. Lanier
Principal Investigator

West Virginia
Morgantown

West Virginia University Healthcare

Mehdi Hamadani
Ph: 414-805-4380
Email: sfilburn@hsc.wvu.edu

Mehdi Hamadani
Principal Investigator

Wisconsin
La Crosse

Gundersen Lutheran Medical Center

Kurt Oettel
Ph: 608-775-2385
Email: cancerctr@gundluth.org

Kurt Oettel
Principal Investigator

New Richmond

Cancer Center of Western Wisconsin

Joseph W. Leach
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Joseph W. Leach
Principal Investigator

Wyoming
Cody

Big Horn Basin Cancer Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Billings Clinic-Cody

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Sheridan

Welch Cancer Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01359592

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.