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

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase IIBiomarker/Laboratory analysis, TreatmentActive18 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:

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

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 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

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

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

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

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

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

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

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

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

Platelet count >= 100,000 cells/mcL

Absolute neutrophil count (ANC) >= 1,000 cells/mcL 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 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 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 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 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

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

SECOND REGISTRATION (STEP 2)

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

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

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

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.

Connecticut
Hartford

Smilow Cancer Hospital Care Center at Saint Francis

Iris Isufi
Ph: 203-785-5702

Iris Isufi
Principal Investigator

New Haven

Yale University

Iris Isufi
Ph: 203-785-5702

Iris Isufi
Principal Investigator

North Haven

Yale-New Haven Hospital North Haven Medical Center

Iris Isufi
Ph: 203-785-5702

Iris Isufi
Principal Investigator

Torrington

Charlotte Hungerford Hospital Center for Cancer Care

Iris Isufi
Ph: 203-785-5702

Iris Isufi
Principal Investigator

Hawaii
Aiea

Hawaii Oncology 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

Hawaii Cancer Care Inc-Liliha

Jeffrey L. Berenberg
Ph: 808-586-2979

Jeffrey L. Berenberg
Principal Investigator

Hawaii Cancer Care Inc-POB II

Jeffrey L. Berenberg
Ph: 808-586-2979

Jeffrey L. Berenberg
Principal Investigator

Hawaii Oncology Inc-Kuakini

Jeffrey L. Berenberg
Ph: 808-586-2979

Jeffrey L. Berenberg
Principal Investigator

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

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

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Saint Luke's Mountain States Tumor Institute

Paul G. Montgomery
Email: protocols@swog.org

Paul G. Montgomery
Principal Investigator

Caldwell

Saint Alphonsus Cancer Care Center-Caldwell

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Coeur D'Alene

Kootenai Medical Center

Benjamin T. Marchello
Ph: 406-969-6060
Email: mccinfo@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Emmett

Walter Knox Memorial Hospital

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Meridian

Idaho Urologic Institute-Meridian

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Nampa

Saint Alphonsus Medical Center-Nampa

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Post Falls

Kootenai Cancer Center

Benjamin T. Marchello
Ph: 406-969-6060
Email: mccinfo@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Sandpoint

Kootenai Cancer Clinic

Benjamin T. Marchello
Ph: 406-969-6060
Email: mccinfo@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Illinois
Bloomington

Illinois CancerCare-Bloomington

James Lloyd Wade
Ph: 309-243-3605

James Lloyd Wade
Principal Investigator

Canton

Illinois CancerCare-Canton

James Lloyd Wade
Ph: 309-243-3605

James Lloyd Wade
Principal Investigator

Carbondale

Memorial Hospital of Carbondale

James Lloyd Wade
Ph: 309-243-3605

James Lloyd Wade
Principal Investigator

Carthage

Illinois CancerCare-Carthage

James Lloyd Wade
Ph: 309-243-3605

James Lloyd Wade
Principal Investigator

Centralia

Centralia Oncology Clinic

James Lloyd Wade
Ph: 309-243-3605

James Lloyd Wade
Principal Investigator

Decatur

Cancer Care Center of Decatur

James Lloyd Wade
Ph: 309-243-3605

James Lloyd Wade
Principal Investigator

Decatur Memorial Hospital

James Lloyd Wade
Ph: 309-243-3605

James Lloyd Wade
Principal Investigator

Effingham

Crossroads Cancer Center

James Lloyd Wade
Ph: 309-243-3605

James Lloyd Wade
Principal Investigator

Eureka

Illinois CancerCare-Eureka

James Lloyd Wade
Ph: 309-243-3605

James Lloyd Wade
Principal Investigator

Galesburg

Illinois CancerCare-Galesburg

James Lloyd Wade
Ph: 309-243-3605

James Lloyd Wade
Principal Investigator

Western Illinois Cancer Treatment Center

James Lloyd Wade
Ph: 309-243-3605

James Lloyd Wade
Principal Investigator

Kewanee

Illinois CancerCare-Kewanee Clinic

James Lloyd Wade
Ph: 309-243-3605

James Lloyd Wade
Principal Investigator

Macomb

Illinois CancerCare-Macomb

James Lloyd Wade
Ph: 309-243-3605

James Lloyd Wade
Principal Investigator

Ottawa

Illinois CancerCare-Ottawa Clinic

James Lloyd Wade
Ph: 309-243-3605

James Lloyd Wade
Principal Investigator

Pekin

Illinois CancerCare-Pekin

James Lloyd Wade
Ph: 309-243-3605

James Lloyd Wade
Principal Investigator

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

James Lloyd Wade
Ph: 309-243-3605

James Lloyd Wade
Principal Investigator

Peoria

Illinois CancerCare-Peoria

James Lloyd Wade
Ph: 309-243-3605

James Lloyd Wade
Principal Investigator

Methodist Medical Center of Illinois

James Lloyd Wade
Ph: 309-243-3605

James Lloyd Wade
Principal Investigator

OSF Saint Francis Medical Center

James Lloyd Wade
Ph: 309-243-3605

James Lloyd Wade
Principal Investigator

OSF Saint Francis Radiation Oncology at Peoria Cancer Center

James Lloyd Wade
Ph: 309-243-3605

James Lloyd Wade
Principal Investigator

Peru

Illinois CancerCare-Peru

James Lloyd Wade
Ph: 309-243-3605

James Lloyd Wade
Principal Investigator

Valley Radiation Oncology

James Lloyd Wade
Ph: 309-243-3605

James Lloyd Wade
Principal Investigator

Princeton

Illinois CancerCare-Princeton

James Lloyd Wade
Ph: 309-243-3605

James Lloyd Wade
Principal Investigator

Springfield

Memorial Medical Center

James Lloyd Wade
Ph: 309-243-3605

James Lloyd Wade
Principal Investigator

Southern Illinois University School of Medicine

James Lloyd Wade
Ph: 309-243-3605

James Lloyd Wade
Principal Investigator

Springfield Clinic

James Lloyd Wade
Ph: 309-243-3605

James Lloyd Wade
Principal Investigator

Swansea

Cancer Care Specialists of Illinois-Swansea

James Lloyd Wade
Ph: 309-243-3605

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: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Dodge City

Cancer Center of Kansas - Dodge City

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

El Dorado

Cancer Center of Kansas - El Dorado

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Fort Scott

Cancer Center of Kansas - Fort Scott

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Independence

Cancer Center of Kansas-Independence

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Kingman

Cancer Center of Kansas-Kingman

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Lawrence

Lawrence Memorial Hospital

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Lenexa

Kansas Institute of Medicine Cancer and Blood Center

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

Rakesh Gaur
Principal Investigator

Minimally Invasive Surgery Hospital

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

Rakesh Gaur
Principal Investigator

Liberal

Cancer Center of Kansas-Liberal

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Manhattan

Cancer Center of Kansas-Manhattan

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

McPherson

Cancer Center of Kansas - McPherson

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Newton

Cancer Center of Kansas - Newton

Shaker R. Dakhil
Ph: 316-268-5374

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: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Prairie Village

Kansas City NCI Community Oncology Research Program

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

Rakesh Gaur
Principal Investigator

Pratt

Cancer Center of Kansas - Pratt

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Salina

Cancer Center of Kansas - Salina

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Wellington

Cancer Center of Kansas - Wellington

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Wichita

Associates In Womens Health

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Cancer Center of Kansas - Wichita

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Cancer Center of Kansas-Wichita Medical Arts Tower

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Via Christi Regional Medical Center

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Wichita NCI Community Oncology Research Program

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Winfield

Cancer Center of Kansas - Winfield

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Michigan
Ann Arbor

Saint Joseph Mercy Hospital

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Brighton

IHA Hematology Oncology Consultants-Brighton

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Saint Joseph Mercy Brighton

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Canton

IHA Hematology Oncology Consultants-Canton

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Saint Joseph Mercy Canton Health Center

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Caro

Caro Cancer Center

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Chelsea

IHA Hematology Oncology Consultants-Chelsea

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Saint Joseph Mercy Chelsea

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Clarkston

Hematology Oncology Consultants-Clarkston

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Newland Medical Associates-Clarkston

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Dearborn

Beaumont Hospital-Dearborn

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Oakwood Healthcare Center-Mercury Drive

Christopher M. Reynolds
Ph: 734-712-4673

Christopher M. Reynolds
Principal Investigator

Parvez Khan Oncology Clinic

Christopher M. Reynolds
Ph: 734-712-4673

Christopher M. Reynolds
Principal Investigator

Detroit

Saint John Hospital and Medical Center

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

East China

Great Lakes Cancer Management Specialists-Doctors Park

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Flint

Genesee Cancer and Blood Disease Treatment Center

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Genesee Hematology Oncology PC

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Genesys Hurley Cancer Institute

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Hurley Medical Center

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Gorsse Pointe Woods

Lymphoma Clinic of Michigan

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Grosse Pointe Woods

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Michigan Breast Specialists-Grosse Pointe Woods

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Jackson

Allegiance Health

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Lansing

Sparrow Hospital

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Livonia

Hope Cancer Clinic

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Saint Mary Mercy Hospital

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Macomb Township

Hematology Oncology Associates East PC

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Michigan Breast Specialists-Macomb Township

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Pontiac

21st Century Oncology-Pontiac

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Hope Cancer Center

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Newland Medical Associates-Pontiac

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Saint Joseph Mercy Oakland

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Rochester Hills

Great Lakes Cancer Management Specialists-Rochester Hills

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Saginaw

Oncology Hematology Associates of Saginaw Valley PC

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Saint Mary's of Michigan

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Sterling Heights

Bhadresh Nayak MD PC-Sterling Heights

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Tawas City

Saint Joseph Health System-Tawas City

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Warren

Great Lakes Cancer Management Specialists-Macomb Professional Building

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Macomb Hematology Oncology PC

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Michigan Breast Specialists-Warren

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Saint John Macomb-Oakland Hospital

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

West Branch

Saint Mary's Oncology/Hematology Associates of West Branch

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Ypsilanti

Huron Gastroenterology PC

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

IHA Hematology Oncology Consultants-Ann Arbor

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Minnesota
Burnsville

Fairview Ridges Hospital

Patrick James Flynn
Ph: 952-993-1517
Email: mmcorc@healthpartners.com

Patrick James Flynn
Principal Investigator

Coon Rapids

Mercy Hospital

Patrick James Flynn
Ph: 952-993-1517
Email: mmcorc@healthpartners.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

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

Bret E.B. Friday
Principal Investigator

Miller-Dwan Hospital

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

Bret E.B. Friday
Principal Investigator

Edina

Fairview-Southdale Hospital

Patrick James Flynn
Ph: 952-993-1517
Email: mmcorc@healthpartners.com

Patrick James Flynn
Principal Investigator

Fridley

Unity Hospital

Patrick James Flynn
Ph: 952-993-1517
Email: mmcorc@healthpartners.com

Patrick James Flynn
Principal Investigator

Maplewood

Minnesota Oncology Hematology PA-Maplewood

Patrick James Flynn
Ph: 952-993-1517
Email: mmcorc@healthpartners.com

Patrick James Flynn
Principal Investigator

Saint John's Hospital - Healtheast

Patrick James Flynn
Ph: 952-993-1517
Email: mmcorc@healthpartners.com

Patrick James Flynn
Principal Investigator

Minneapolis

Abbott-Northwestern Hospital

Patrick James Flynn
Ph: 952-993-1517
Email: mmcorc@healthpartners.com

Patrick James Flynn
Principal Investigator

Health Partners Inc

Patrick James Flynn
Ph: 952-993-1517
Email: mmcorc@healthpartners.com

Patrick James Flynn
Principal Investigator

Hennepin County Medical Center

Patrick James Flynn
Ph: 952-993-1517
Email: mmcorc@healthpartners.com

Patrick James Flynn
Principal Investigator

New Ulm

New Ulm Medical Center

Patrick James Flynn
Ph: 952-993-1517
Email: mmcorc@healthpartners.com

Patrick James Flynn
Principal Investigator

Robbinsdale

North Memorial Medical Health Center

Patrick James Flynn
Ph: 952-993-1517
Email: mmcorc@healthpartners.com

Patrick James Flynn
Principal Investigator

Saint Louis Park

Metro Minnesota Community Oncology Research Consortium

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

Patrick James Flynn
Principal Investigator

Park Nicollet Clinic - Saint Louis Park

Patrick James Flynn
Ph: 952-993-1517
Email: mmcorc@healthpartners.com

Patrick James Flynn
Principal Investigator

Saint Paul

Regions Hospital

Patrick James Flynn
Ph: 952-993-1517
Email: mmcorc@healthpartners.com

Patrick James Flynn
Principal Investigator

United Hospital

Patrick James Flynn
Ph: 952-993-1517
Email: mmcorc@healthpartners.com

Patrick James Flynn
Principal Investigator

Shakopee

Saint Francis Regional Medical Center

Patrick James Flynn
Ph: 952-993-1517
Email: mmcorc@healthpartners.com

Patrick James Flynn
Principal Investigator

Stillwater

Lakeview Hospital

Patrick James Flynn
Ph: 952-993-1517
Email: mmcorc@healthpartners.com

Patrick James Flynn
Principal Investigator

Waconia

Ridgeview Medical Center

Patrick James Flynn
Ph: 952-993-1517
Email: mmcorc@healthpartners.com

Patrick James Flynn
Principal Investigator

Willmar

Rice Memorial Hospital

Patrick James Flynn
Ph: 952-993-1517
Email: mmcorc@healthpartners.com

Patrick James Flynn
Principal Investigator

Woodbury

Minnesota Oncology Hematology PA-Woodbury

Patrick James Flynn
Ph: 952-993-1517
Email: mmcorc@healthpartners.com

Patrick James Flynn
Principal Investigator

Missouri
Bonne Terre

Parkland Health Center-Bonne Terre

James Lloyd Wade
Ph: 309-243-3605

James Lloyd Wade
Principal Investigator

Cape Girardeau

Saint Francis Medical Center

James Lloyd Wade
Ph: 309-243-3605

James Lloyd Wade
Principal Investigator

Southeast Cancer Center

James Lloyd Wade
Ph: 309-243-3605

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: 309-243-3605

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

Addison R. Tolentino
Ph: 888-823-5923
Email: ctsucontact@westat.com

Addison R. Tolentino
Principal Investigator

Lee's Summit

Saint Luke's East - Lee's Summit

Addison R. Tolentino
Ph: 888-823-5923
Email: ctsucontact@westat.com

Addison R. Tolentino
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: 309-243-3605

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: 309-243-3605

James Lloyd Wade
Principal Investigator

Sullivan

Missouri Baptist Sullivan Hospital

James Lloyd Wade
Ph: 309-243-3605

James Lloyd Wade
Principal Investigator

Sunset Hills

Missouri Baptist Outpatient Center-Sunset Hills

James Lloyd Wade
Ph: 309-243-3605

James Lloyd Wade
Principal Investigator

Montana
Anaconda

Community Hospital of Anaconda

Benjamin T. Marchello
Ph: 406-969-6060
Email: mccinfo@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Billings

Billings Clinic Cancer Center

Benjamin T. Marchello
Ph: 406-969-6060
Email: mccinfo@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Montana Cancer Consortium NCORP

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Bozeman

Bozeman Deaconess Hospital

Benjamin T. Marchello
Ph: 406-969-6060
Email: mccinfo@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Great Falls

Benefis Healthcare- Sletten Cancer Institute

Benjamin T. Marchello
Ph: 406-969-6060
Email: mccinfo@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Great Falls Clinic

Benjamin T. Marchello
Ph: 406-969-6060
Email: mccinfo@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Helena

Saint Peter's Community Hospital

Benjamin T. Marchello
Ph: 406-969-6060
Email: mccinfo@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Kalispell

Kalispell Regional Medical Center

Benjamin T. Marchello
Ph: 406-969-6060
Email: mccinfo@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Missoula

Community Medical Hospital

Benjamin T. Marchello
Ph: 406-969-6060
Email: mccinfo@mtcancer.org

Benjamin T. Marchello
Principal Investigator

New York
Middletown

Orange Regional Medical Center

Jeffrey M. Stewart
Ph: 845-342-7609

Jeffrey M. Stewart
Principal Investigator

North Carolina
Chapel Hill

UNC Lineberger Comprehensive Cancer Center

Thomas Charles Shea
Ph: 877-668-0683
Email: cancerclinicaltrials@med.unc.edu

Thomas Charles Shea
Principal Investigator

North Dakota
Fargo

Roger Maris Cancer Center

Preston D. Steen
Ph: 712-252-0088

Preston D. Steen
Principal Investigator

Sanford Broadway Medical Center

Preston D. Steen
Ph: 712-252-0088

Preston D. Steen
Principal Investigator

Sanford Clinic North-Fargo

Preston D. Steen
Ph: 712-252-0088

Preston D. Steen
Principal Investigator

Ohio
Canton

Mercy Medical Center

Mitchell Haut
Ph: 888-293-4673

Mitchell Haut
Principal Investigator

Oregon
Baker City

Saint Alphonsus Medical Center-Baker City

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

Ontario

Saint Alphonsus Medical Center-Ontario

Christopher M. Reynolds
Ph: 208-367-7954

Christopher M. Reynolds
Principal Investigator

South Carolina
Greenville

Greenville Health System Cancer Institute-Butternut

Jeffrey Kent Giguere
Ph: 864-679-3966

Jeffrey Kent Giguere
Principal Investigator

Greenville Health System Cancer Institute-Eastside

Jeffrey Kent Giguere
Ph: 864-679-3966

Jeffrey Kent Giguere
Principal Investigator

Greenville Health System Cancer Institute-Faris

Jeffrey Kent Giguere
Ph: 864-679-3966

Jeffrey Kent Giguere
Principal Investigator

Greenville Memorial Hospital

Jeffrey Kent Giguere
Ph: 864-679-3966

Jeffrey Kent Giguere
Principal Investigator

Saint Francis Cancer Center

Robert D. Siegel
Ph: 864-255-1713

Robert D. Siegel
Principal Investigator

Saint Francis Hospital

Robert D. Siegel
Ph: 864-255-1713

Robert D. Siegel
Principal Investigator

Greer

Greenville Health System Cancer Institute-Greer

Jeffrey Kent Giguere
Ph: 864-679-3966

Jeffrey Kent Giguere
Principal Investigator

Seneca

Greenville Health System Cancer Institute-Seneca

Jeffrey Kent Giguere
Ph: 864-679-3966

Jeffrey Kent Giguere
Principal Investigator

Spartanburg

Greenville Health System Cancer Institute-Spartanburg

Jeffrey Kent Giguere
Ph: 864-679-3966

Jeffrey Kent Giguere
Principal Investigator

South Dakota
Sioux Falls

Sanford Cancer Center-Oncology Clinic

Preston D. Steen
Ph: 712-252-0088

Preston D. Steen
Principal Investigator

Sanford USD Medical Center - Sioux Falls

Preston D. Steen
Ph: 712-252-0088

Preston D. Steen
Principal Investigator

Washington
Seattle

Fred Hutchinson Cancer Research Center

Brian Gerald Till
Ph: 800-422-6237

Brian Gerald Till
Principal Investigator

Seattle Cancer Care Alliance

Brian Gerald Till
Ph: 800-422-6237

Brian Gerald Till
Principal Investigator

University of Washington Medical Center

Brian Gerald Till
Ph: 800-422-6237

Brian Gerald Till
Principal Investigator

West Virginia
Morgantown

West Virginia University Healthcare

Abraham Sebastian Kanate
Ph: 304-293-7374
Email: cancertrialsinfo@hsc.wvu.edu

Abraham Sebastian Kanate
Principal Investigator

Wisconsin
New Richmond

Cancer Center of Western Wisconsin

Patrick James Flynn
Ph: 952-993-1517
Email: mmcorc@healthpartners.com

Patrick James Flynn
Principal Investigator

Wyoming
Cody

Billings Clinic-Cody

Benjamin T. Marchello
Ph: 406-969-6060
Email: mccinfo@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Sheridan

Welch Cancer Center

Benjamin T. Marchello
Ph: 406-969-6060
Email: mccinfo@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifier 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.