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Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Older Patients With Previously Untreated Mantle Cell Lymphoma

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, Supportive care, TreatmentActive60 and overNCI, OtherCDR0000707057
ECOG-E1411, E1411, NCT01415752

Trial Description

Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer cells or stop them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of mantle cell lymphoma by blocking blood flow to the cancer. It is not yet known whether giving rituximab together with bendamustine and bortezomib is more effective than rituximab and bendamustine, followed by rituximab alone or with lenalidomide in treating mantle cell lymphoma.

PURPOSE: This randomized phase II trial studies rituximab, bortezomib, bendamustine, and lenalidomide in treating previously untreated older patients with mantle cell lymphoma.

Further Study Information

OBJECTIVES:

Primary

  • To determine whether the addition of bortezomib (RBV) to an induction regimen of rituximab-bendamustine hydrochloride (RB) improves progression-free survival (PFS) compared to RB alone in patients ≥ 60 years of age with previously untreated mantle cell lymphoma.
  • To determine whether the addition of lenalidomide to a consolidation regimen of rituximab following an induction regimen of RB or RBV improves PFS compared to consolidation rituximab alone in this patient population.

Secondary

  • To determine whether the addition of bortezomib to induction therapy improves the positron emission tomography (PET)-documented complete response (CR) rate compared to RB alone.
  • To determine the objective response rate (ORR) for RB and RBV.
  • Among patients who do not have PET-documented CR at the end of induction, to determine whether the addition of lenalidomide to consolidation therapy improves CR and ORR compared with rituximab alone.
  • To determine overall survival (OS) in the treatment arms.
  • To determine safety, with attention to the addition of bortezomib in the induction regimen and lenalidomide-rituximab (LR) as consolidation therapy.
  • To collect paraffin-embedded tissue for creation of tissue microarray.
  • To collect and bank serum and blood mononuclear cells for future studies.
  • To collect formalin-fixed paraffin-embedded (FFPE) tissue to analyze potential prognostic factors (Ki-67 proliferation index by immunohistochemistry and correlation with proposed 5-gene set of proliferation markers analyzed by RNA PCR; SOX 11 expression by immunohistochemistry; and Micro-RNA levels by microarray).
  • Using patient-reported outcomes data, to determine the extent and severity of neuropathy associated with the addition of bortezomib to induction treatment.
  • Using patient-reported outcomes data, to determine the extent and severity of fatigue associated with the addition of lenalidomide to consolidation treatment.
  • To evaluate the effects of the addition of bortezomib and lenalidomide on patient-reported health-related quality of life.
  • To evaluate the effects of bortezomib-related neuropathy on patient-reported health-related quality of life.
  • To evaluate the response of lymphoma-specific symptoms to treatment.
  • Using longitudinal patient-reported outcomes data, to describe the trajectory of lymphoma symptoms, neuropathy, fatigue, and overall health-related quality of life prior to, during, and following treatment among older adults with MCL.

Tertiary

  • To assess the proportion of patients up and down staging when fludeoxyglucose F 18- (FDG) PET/CT is added to standard Ann Arbor staging.
  • To assess the ability of pre-treatment FDG-PET/CT (SUVmax) to predict response rate and PFS.
  • Among patients with interim (post-cycle 3) FDG-PET/CT imaging, to assess the correlation of interim FDG-PET/CT imaging with response rate and PFS both during induction and consolidation therapy.
  • To assess standard FDG-PET/CT metrics including SUVmax, tumor metabolic burden, total tumor burden, and association with pathology features (blastoid variant vs other, and Ki67) in the setting of MCL.
  • To assess differences in overall and CR rates when using Deauville vs International Harmonization Project FDG-PET/CT interpretation criteria.
  • To determine whether there is a correlation between FDG-PET/CT response and residual disease assessment by molecular and/or flow cytometric techniques.
  • To determine whether the number of malignant cells in circulation predict the number of cells in marrow.
  • To determine whether the number of malignant cells in circulation/in marrow at the end of induction correlate with CR and 2-year PFS.
  • To determine whether there is a higher rate of minimal residual disease (MRD) negativity among patients randomized to RBV as compared with RB, and among patients treated with LR maintenance compared with rituximab.
  • To compare the two methods of MRD detection - molecular techniques and flow cytometry - as prognostic markers for outcome.

OUTLINE: This is a multicenter study. Patients are stratified according to mantle cell lymphoma International Prognostic Index risk score (low vs intermediate vs high). Patients are randomized to 1 of 4 treatment arms.

  • Arm A: Patients receive induction therapy comprising rituximab IV on day 1 and bendamustine hydrochloride IV over 60 minutes on days 1-2. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
  • Arm E: Patients receive consolidation therapy comprising rituximab IV on day 1. Courses repeat every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
  • Arm B: Patients receive induction therapy comprising bortezomib IV or subcutaneously (SC) on days 1, 4, 8, and 11 and rituximab and bendamustine hydrochloride as patients in arm A. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
  • Arm F: Patients receive consolidation therapy comprising rituximab IV on day 1. Courses repeat every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
  • Arm C: Patients receive induction therapy comprising rituximab and bendamustine hydrochloride as patients in arm A. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
  • Arm G: Patients receive consolidation therapy comprising lenalidomide orally (PO) daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
  • Arm D: Patients receive bortezomib, rituximab, and bendamustine hydrochloride as patients in arm B. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
  • Arm H: Patients receive consolidation therapy comprising lenalidomide PO daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.

Patients may undergo blood and bone marrow sample collection at baseline and during treatment for correlative studies.

Patients complete the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym), the FACT/GOG-Neurotoxicity scale (FACT/GOG-Ntx), FACT-Fatigue, and FACT-General questionnaires at baseline and periodically during study and follow up.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually for 10 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed untreated mantle cell lymphoma (MCL), with documented cyclin D1 by immunohistochemical stains and/or t(11;14) by cytogenetics or fluorescence in situ hybridization (FISH)
  • Patients must have at least one objective measurable disease parameter
  • Abnormal PET scans will not constitute evaluable disease, unless verified by CT scan or other appropriate imaging
  • Measurable disease in the liver is required if the liver is the only site of lymphoma
  • Patient must have no CNS involvement

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • ANC ≥ 1,500/mcL (1.5 x 10^9/L)*
  • Platelets ≥ 100,000/mcL (100 x 10^9/L)* NOTE: *Unless due to marrow involvement.
  • AST/ALT ≤ 2 times upper limit of normal (ULN)
  • Bilirubin ≤ 2 times ULN
  • Calculated creatinine clearance by Cockroft-Gault formula ≥ 30 mL/min
  • Women (sexually mature female) must not be pregnant or breast-feeding
  • Negative pregnancy test
  • Women of childbearing potential and sexually active males use an accepted and effective method of contraception
  • Men must agree to use a latex condom during sexual contact with a female of child-bearing potential, even if they have had a successful vasectomy
  • All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure
  • No evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma, or any surgically or radiation-cured malignancy continuously disease free for ≥ 5 years so as not to interfere with interpretation of radiographic response
  • Patient agrees that if randomized to Arms C or D, and proceed onto Arms G or H, they must register into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®
  • Patients must have no medical contra-indications to, and be willing to take, deep vein thrombosis (DVT) prophylaxis as all patients registering to the lenalidomide/rituximab Arms G and H will be required to have DVT prophylaxis
  • Patients randomized to Arms G or H who have a history of a thrombotic vascular event will be required to have therapeutic doses of low-molecular weight heparin or warfarin to maintain an INR between 2.0 - 3.0
  • Patients on Arms G and H without a history of a thromboembolic event are required to take a daily aspirin (81 mg or 325 mg) for DVT prophylaxis
  • Patients who are unable to tolerate aspirin should receive low molecular weight heparin therapy or warfarin treatment
  • Women must agree to abstain from donating blood during study participation and for at least 28 days after discontinuation from protocol treatment
  • Males must agree to abstain from donating blood, semen, or sperm during study participation and for at least 28 days after discontinuation from protocol treatment
  • HIV-positive patients are not excluded but, to enroll, must meet all of the below criteria:
  • HIV is sensitive to antiretroviral therapy
  • Must be willing to take effective antiretroviral therapy, if indicated
  • No history of CD4 prior to or at the time of lymphoma diagnosis < 300 cells/mm³
  • No history of AIDS-defining conditions
  • If on antiretroviral therapy, must not be taking zidovudine or stavudine
  • Must be willing to take prophylaxis for Pneumocystis jiroveci pneumonia (PCP) during therapy and until at least 2 months following the completion of therapy or until the CD4 cells recover to over 250 cells/mm³, whichever occurs later
  • Patients must not have grade 2 or greater peripheral neuropathy
  • Patients must not have NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia
  • Patients must not have hypersensitivity to bortezomib, boron, or mannitol
  • Patients must not have a serious medical or psychiatric illness likely to interfere with study participation

PRIOR CONCURRENT THERAPY:

  • No prior therapy for MCL, except < 1 week of steroid therapy for symptom control
  • HIV-positive patients are not excluded, but to enroll, must meet all of the below criteria:
  • Must be willing to take effective antiretroviral therapy if indicated
  • If on antiretroviral therapy, must not be taking zidovudine or stavudine
  • Patients must not be participating in any other clinical trial or taking any other experimental medications within 14 days prior to registration

Trial Contact Information

Trial Lead Organizations/Sponsors

Eastern Cooperative Oncology Group

National Cancer Institute

Mitchell Reed SmithPrincipal Investigator

Trial Sites

U.S.A.
Alaska
  Anchorage
 Alaska Breast Care and Surgery LLC
 Alison K Conlin Ph: 503-215-6412
 Alaska Women's Cancer Care
 Alison K Conlin Ph: 503-215-6412
 Anchorage Oncology Centre
 Alison K Conlin Ph: 503-215-6412
 Katmai Oncology Group
 Alison K Conlin Ph: 503-215-6412
 Providence Cancer Center
 Alison K Conlin Ph: 503-215-6412
California
  Antioch
 Kaiser Permanente - Deer Valley
 Tatjana Kolevska Ph: 626-564-3455
  Fremont
 Kaiser Permanente - Fremont
 Tatjana Kolevska Ph: 626-564-3455
  Fresno
 Kaiser Permanente Fresno Medical Center
 Tatjana Kolevska Ph: 626-564-3455
  Hayward
 Kaiser Permanente Medical Center - Hayward
 Tatjana Kolevska Ph: 626-564-3455
  Los Angeles
 USC/Norris Comprehensive Cancer Center and Hospital
 Anil Tulpule Ph: 323-865-0451
 Anil Tulpule Ph: 323-865-0451
  Modesto
 Kaiser Permanente-Modesto
 Tatjana Kolevska Ph: 626-564-3455
  Oakland
 Kaiser Permanente-Oakland
 Tatjana Kolevska Ph: 626-564-3455
  Redwood City
 Kaiser Permanente Medical Center - Redwood City
 Tatjana Kolevska Ph: 626-564-3455
  Richmond
 Kaiser Permanente Medical Center - Richmond
 Tatjana Kolevska Ph: 626-564-3455
  Roseville
 Kaiser Permanente Medical Center - Roseville
 Tatjana Kolevska Ph: 626-564-3455
  Sacramento
 Kaiser Permanente Medical Center - Sacramento
 Tatjana Kolevska Ph: 626-564-3455
 South Sacramento Kaiser-Permanente Medical Center
 Tatjana Kolevska Ph: 626-564-3455
  San Francisco
 Kaiser Permanente Medical Center - San Francisco Geary Campus
 Tatjana Kolevska Ph: 626-564-3455
  San Jose
 Kaiser Permanente Medical Center - Santa Teresa
 Tatjana Kolevska Ph: 626-564-3455
  San Rafael
 Kaiser Foundation Hospital - San Rafael
 Tatjana Kolevska Ph: 626-564-3455
  Santa Clara
 Kaiser Permanente Medical Center - Santa Clara Homestead Campus
 Tatjana Kolevska Ph: 626-564-3455
  Santa Rosa
 Kaiser Permanente Medical Center - Santa Rosa
 Tatjana Kolevska Ph: 626-564-3455
  South San Francisco
 Kaiser Permanente Medical Center - South San Francisco
 Tatjana Kolevska Ph: 626-564-3455
  Stanford
 Stanford Cancer Center
 Ranjana Advani Ph: 650-498-7061
  Email: clinicaltrials@med.stanford.edu
  Stockton
 Kaiser Permanente Medical Facility - Stockton
 Tatjana Kolevska Ph: 626-564-3455
  Vacaville
 Kaiser Permanente Medical Center - Vacaville
 Tatjana Kolevska Ph: 626-564-3455
  Vallejo
 Kaiser Permanente Medical Center - Vallejo
 Tatjana Kolevska Ph: 626-564-3455
  Walnut Creek
 Kaiser Permanente Medical Center - Walnut Creek
 Tatjana Kolevska Ph: 626-564-3455
Colorado
  Aurora
 Medical Center of Aurora - South Campus
 Keren Sturtz Ph: 888-785-6789
  Boulder
 Boulder Community Hospital
 Keren Sturtz Ph: 888-785-6789
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Keren Sturtz Ph: 888-785-6789
  Denver
 CCOP - Colorado Cancer Research Program
 Keren Sturtz Ph: 888-785-6789
 Kaiser Permanente of Colorado
 Alexander Menter Ph: 720-225-4203
 Porter Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Presbyterian - St. Luke's Medical Center
 Keren Sturtz Ph: 888-785-6789
 Rose Medical Center
 Keren Sturtz Ph: 888-785-6789
 St. Joseph Hospital
 Keren Sturtz Ph: 888-785-6789
  Durango
 Mercy Medical Center
 Cynthia K. Cathcart Ph: 888-785-6789
  Englewood
 Swedish Medical Center
 Keren Sturtz Ph: 888-785-6789
  Fort Collins
 Poudre Valley Hospital
 Miho T Scott Ph: 970-297-6150
  Greeley
 North Colorado Medical Center
 Keren Sturtz Ph: 888-785-6789
  Lakewood
 St. Anthony Central Hospital
 Keren Sturtz Ph: 888-785-6789
  Littleton
 Littleton Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
  Lone Tree
 Kaiser Permanente-Lone Tree
 Alexander Menter Ph: 720-225-4203
 Sky Ridge Medical Center
 Keren Sturtz Ph: 888-785-6789
  Longmont
 Hope Cancer Care Center at Longmont United Hospital
 Keren Sturtz Ph: 888-785-6789
  Loveland
 McKee Medical Center
 Keren Sturtz Ph: 888-785-6789
  Parker
 Parker Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
  Pueblo
 St. Mary - Corwin Regional Medical Center
 Keren Sturtz Ph: 888-785-6789
  Wheat Ridge
 Exempla Lutheran Medical Center
 Keren Sturtz Ph: 888-785-6789
Connecticut
  Hartford
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Christopher M Reynolds Ph: 734-712-3456
Delaware
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 Gregory A. Masters Ph: 302-733-6227
  Newark
 Helen F. Graham Cancer Center at Christiana Hospital
 Gregory A. Masters Ph: 302-733-6227
  Seaford
 Nanticoke Memorial Hospital
 Gregory A. Masters Ph: 302-733-6227
Florida
  Orlando
 M.D. Anderson Cancer Center at Orlando
 Jose E. Sarriera Ph: 321-841-7246
Hawaii
  Aiea
 Kapiolani Medical Center at Pali Momi
 Jeffrey L. Berenberg Ph: 808-586-2979
 Jeffrey L. Berenberg Ph: 808-586-2979
  Honolulu
 Cancer Research Center of Hawaii
 Jeffrey L. Berenberg Ph: 808-586-2979
 Kaiser Permanente - Moanalua Medical Center and Clinic
 Tatjana Kolevska Ph: 626-564-3455
 Kapiolani Medical Center for Women and Children
 Jeffrey L. Berenberg Ph: 808-586-2979
 OnCare Hawaii, Incorporated - Kuakini
 Jeffrey L. Berenberg Ph: 808-586-2979
 Jeffrey L. Berenberg Ph: 808-586-2979
 OnCare Hawaii, Incorporated - Lusitana
 Jeffrey L. Berenberg Ph: 808-586-2979
 Queen's Cancer Institute at Queen's Medical Center
 Jeffrey L. Berenberg Ph: 808-586-2979
 Straub Clinic and Hospital, Incorporated
 Jeffrey L. Berenberg Ph: 808-586-2979
  Kailua
 Castle Medical Center
 Jeffrey L. Berenberg Ph: 808-586-2979
  Lihue
 Kauai Medical Clinic
 Jeffrey L. Berenberg Ph: 808-586-2979
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Christopher M Reynolds Ph: 734-712-3456
  Post Falls
 Kootenai Cancer Center - Post Falls
 Benjamin Thomas Marchello Ph: 800-648-6274
Illinois
  Chicago
 John H. Stroger, Jr. Hospital of Cook County
 Luis D Sumoza Benitez Ph: 312-864-6000
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 Jane N. Winter Ph: 312-695-1301
  Email: cancer@northwestern.edu
  Decatur
 Decatur Memorial Hospital Cancer Care Institute
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Kankakee
 Provena St. Mary's Regional Cancer Center - Kankakee
 Jane N. Winter Ph: 312-695-1301
  Email: cancer@northwestern.edu
  Libertyville
 North Shore Oncology and Hematology Associates, Limited - Libertyville
 Jane N. Winter Ph: 312-695-1301
  Email: cancer@northwestern.edu
  Mount Vernon
 Good Samaritan Regional Health Center
 Jay W Carlson Ph: 888-244-6061
  Email: sherrijr@iora.org
  Niles
 Cancer Care and Hematology Specialists of Chicagoland - Niles
 Jane N. Winter Ph: 312-695-1301
  Email: cancer@northwestern.edu
  Rockford
 Advanced Care and Treatment Medical Group, PC
 Harvey Eric Einhorn Ph: 779-696-9400
  Email: cancercare@swedishamerican.org
  Skokie
 Hematology Oncology Associates - Skokie
 Jane N. Winter Ph: 312-695-1301
  Email: cancer@northwestern.edu
  Springfield
 Regional Cancer Center at Memorial Medical Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Urbana
 Carle Cancer Center at Carle Foundation Hospital
 Maria T Grosse-Perdekamp Ph: 800-446-5532
  Email: kcheek@dmhhs.org
Indiana
  Beech Grove
 St. Francis Hospital and Health Centers - Beech Grove Campus
 Howard M. Gross Ph: 765-983-3000
  Indianapolis
 St. Francis Hospital Cancer Care Services
 Howard M. Gross Ph: 765-983-3000
  Lafayette
 Clarian Arnett Cancer Care
 Thomas Isaac Jones Ph: 800-899-8448ext7431
  Email: sstidham@clarianarnett.com
  Michigan City
 Saint Anthony Memorial Health Centers
 Maria T Grosse-Perdekamp Ph: 800-446-5532
  Email: kcheek@dmhhs.org
  Richmond
 Reid Hospital & Health Care Services
 Howard M. Gross Ph: 317-783-8918
Iowa
  Ames
 McFarland Clinic, PC
 Joseph James Merchant Ph: 515-239-2621
  Bettendorf
 Hematology Oncology Associates of the Quad Cities
 Shobha R. Chitneni Ph: 563-355-7733
  Email: kedaprile@rccqc.com
  Sioux City
 Mercy Medical Center - Sioux City
 Donald Bruce Wender Ph: 712-252-0088
 Siouxland Hematology-Oncology Associates, LLP
 Donald Bruce Wender Ph: 712-252-0088
 St. Luke's Regional Medical Center
 Donald Bruce Wender Ph: 712-252-0088
Kansas
  Lawrence
 Lawrence Memorial Hospital
 Shaker R. Dakhil Ph: 316-262-4467
  Wichita
 Wesley Medical Center
 Shaker R. Dakhil Ph: 316-262-4467
Louisiana
  Baton Rouge
 Ochsner Health Center - Bluebonnet
 Robert V. Emmons Ph: 888-562-4763
  New Orleans
 New Orleans Cancer Institute at Memorial Medical Center
 Robert V. Emmons Ph: 888-562-4763
 Ochsner Cancer Institute at Ochsner Clinic Foundation
 Robert V. Emmons Ph: 888-562-4763
Maine
  Augusta
 Harold Alfond Center for Cancer Care
 Thomas Henry Openshaw Ph: 207-973-4274
  Bangor
 CancerCare of Maine at Eastern Maine Medical Center
 Thomas Henry Openshaw Ph: 207-973-4274
Massachusetts
  Springfield
 Baystate Medical Center
 Syed S Ali Ph: 413-794-3565
  Email: tamara.wrenn@baystatehealth.org
  Worcester
 UMASS Memorial Cancer Center - University Campus
 Andrew M Evens Ph: 617-636-5000
  Email: ContactUsCancerCenter@TuftsMedicalCenter.org
Michigan
  Ann Arbor
 CCOP - Michigan Cancer Research Consortium
 Christopher M Reynolds Ph: 734-712-3456
 Saint Joseph Mercy Cancer Center
 Christopher M Reynolds Ph: 734-712-3456
  Battle Creek
 Battle Creek Health System Cancer Care Center
 Gilbert D Padula Ph: 616-685-5225
  Big Rapids
 Mecosta County Medical Center
 Gilbert D Padula Ph: 616-685-5225
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Christopher M Reynolds Ph: 734-712-3456
  Detroit
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Christopher M Reynolds Ph: 734-712-3456
 Wayne State University
 Radhakrishnan Ramchandren Ph: 313-576-9363
  Escanaba
 Green Bay Oncology, Limited - Escanaba
 Gerald K. Bayer Ph: 800-432-6049
  Flint
 Genesys Hurley Cancer Institute
 Christopher M Reynolds Ph: 734-712-3456
 Philip J. Stella Ph: 734-712-3456
 Hurley Medical Center
 Christopher M Reynolds Ph: 734-712-3456
  Grand Rapids
 Butterworth Hospital at Spectrum Health
 Gilbert D Padula Ph: 616-685-5225
 CCOP - Grand Rapids
 Gilbert D Padula Ph: 616-685-5225
 Lacks Cancer Center at Saint Mary's Health Care
 Gilbert D Padula Ph: 616-685-5225
  Iron Mountain
 Green Bay Oncology - Iron Mountain
 Brian L Burnette Ph: 800-432-6049
  Jackson
 Gayle M. Jacob Cancer Center at Allegiance Health
 Christopher M Reynolds Ph: 734-712-3456
  Kalamazoo
 Borgess Medical Center
 Raymond Sterling Lord Ph: 269-373-7458
 Bronson Methodist Hospital
 Raymond Sterling Lord Ph: 269-373-7458
 West Michigan Cancer Center
 Raymond Sterling Lord Ph: 269-373-7458
  Lansing
 Sparrow Regional Cancer Center
 Christopher M Reynolds Ph: 734-712-3456
  Livonia
 St. Mary Mercy Hospital
 Christopher M Reynolds Ph: 734-712-3456
  Muskegon
 Mercy General Health Partners
 Gilbert D Padula Ph: 616-685-5225
  Pontiac
 St. Joseph Mercy Oakland
 Christopher M Reynolds Ph: 734-712-3456
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Christopher M Reynolds Ph: 734-712-3456
  Reed City
 Spectrum Health Reed City Hospital
 Gilbert D Padula Ph: 616-685-5225
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Christopher M Reynolds Ph: 734-712-3456
  Traverse City
 Munson Medical Center
 Gilbert D Padula Ph: 616-685-5225
  Warren
 St. John Macomb Hospital
 Christopher M Reynolds Ph: 734-712-3456
Minnesota
  Bemidji
 MeritCare Bemidji
 Preston D. Steen Ph: 701-234-6161
  Burnsville
 Fairview Ridges Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Duluth
 CCOP - Duluth
 Daniel Nikcevich Ph: 888-203-7267
 Essentia Health - Duluth Clinic
 Daniel Nikcevich Ph: 888-203-7267
 Miller - Dwan Medical Center
 Daniel Nikcevich Ph: 888-203-7267
  Edina
 Fairview Southdale Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Hutchinson
 Hutchinson Area Health Care
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Maplewood
 HealthEast Cancer Care at St. John's Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Minnesota Oncology - Maplewood
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Minneapolis
 Hennepin County Medical Center - Minneapolis
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  New Ulm
 New Ulm Medical Center
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Robbinsdale
 Humphrey Cancer Center at North Memorial Outpatient Center
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Rochester
 Mayo Clinic Cancer Center
 David James Inwards Ph: 507-538-7623
  Saint Louis Park
 CCOP - Metro-Minnesota
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Park Nicollet Cancer Center
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Saint Paul
 Regions Hospital Cancer Care Center
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 United Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Shakopee
 St. Francis Cancer Center at St. Francis Medical Center
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Stillwater
 Lakeview Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Waconia
 Ridgeview Medical Center
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Willmar
 Willmar Cancer Center at Rice Memorial Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Woodbury
 Minnesota Oncology - Woodbury
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
Missouri
  Cape Girardeau
 Southeast Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
  Chesterfield
 Saint Luke's Hospital
 Donald F. Busiek Ph: 314-205-6936
  Columbia
 Ellis Fischel Cancer Center at University of Missouri - Columbia
 Carl E. Freter Ph: 573-882-7440
  Jefferson City
 Goldschmidt Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
  Joplin
 Freeman Cancer Institute at Freeman Health System
 Jay W Carlson Ph: 888-244-6061
  Email: sherrijr@iora.org
  Rolla
 Phelps County Regional Medical Center
 Robert L Carolla Ph: 417-269-4520
  Saint Louis
 David C. Pratt Cancer Center at St. John's Mercy
 Jay W Carlson Ph: 888-244-6061
  Email: sherrijr@iora.org
 Mercy Clinic St. Louis Cancer and Breast Institute
 Jay W Carlson Ph: 888-244-6061
  Email: sherrijr@iora.org
 Missouri Baptist Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Nancy L. Bartlett Ph: 800-600-3606
  Email: info@siteman.wustl.edu
  Springfield
 Cancer Research for the Ozarks
 Jay W Carlson Ph: 888-244-6061
  Email: sherrijr@iora.org
 Hulston Cancer Center at Cox Medical Center South
 Jay W Carlson Ph: 888-244-6061
  Email: sherrijr@iora.org
 St. John's Regional Health Center
 Jay W Carlson Ph: 888-244-6061
  Email: sherrijr@iora.org
Montana
  Billings
 Billings Clinic Cancer Center - 801 N 29th Street
 Benjamin Thomas Marchello Ph: 800-648-6274
 CCOP - Montana Cancer Consortium
 Benjamin Thomas Marchello Ph: 800-648-6274
 St. Vincent Healthcare Cancer Care Services
 Benjamin Thomas Marchello Ph: 800-648-6274
  Bozeman
 Bozeman Deaconess Cancer Center
 Benjamin Thomas Marchello Ph: 800-648-6274
  Butte
 St. James Healthcare Cancer Care
 Benjamin Thomas Marchello Ph: 800-648-6274
  Great Falls
 Benefis Sletten Cancer Institute
 Benjamin Thomas Marchello Ph: 800-648-6274
  Helena
 St. Peter's Hospital
 Benjamin Thomas Marchello Ph: 800-648-6274
  Kalispell
 Kalispell Regional Medical Center
 Benjamin Thomas Marchello Ph: 800-648-6274
  Missoula
 Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
 Benjamin Thomas Marchello Ph: 800-648-6274
 Montana Cancer Specialists at Montana Cancer Center
 Benjamin Thomas Marchello Ph: 800-648-6274
New Hampshire
  Lebanon
 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
 Frederick Lansigan Ph: 800-639-6918
  Email: cancer.research.nurse@dartmouth.edu
New Jersey
  Camden
 Cancer Institute of New Jersey at Cooper University Hospital - Camden
 Gregory A. Masters Ph: 302-733-6227
  East Orange
 Veterans Affairs Medical Center - East Orange
 Basil S. Kasimis Ph: 800-475-2336
  Email: patricia.goyer@med.va.gov
New York
  Bronx
 Jack D. Weiler Hospital at Montefiore Medical Center - East Campus
 Ramakrishna Battini Ph: 718-904-2730
  Email: aecc@aecom.yu.edu
 Montefiore Medical Center
 Ramakrishna Battini Ph: 718-904-2730
  Email: aecc@aecom.yu.edu
  East Syracuse
 CCOP - Hematology-Oncology Associates of Central New York
 Jeffrey J. Kirshner Ph: 315-472-7504
  Glens Falls
 Charles R. Wood Cancer Center at Glens Falls Hospital
 John P Stoutenburg Ph: 518-926-6700
  Rochester
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Jonathan W Friedberg Ph: 585-275-5830
North Carolina
  Goldsboro
 Wayne Memorial Hospital, Incorporated
 James N. Atkins Ph: 919-580-0000
  Hendersonville
 Comprehensive Cancer Center at Pardee Hospital
 James E. Radford Ph: 828-696-4716
 Park Ridge Hospital Breast Health Center
 Charles E Bowers Ph: 800-486-5941
  Kinston
 Kinston Medical Specialists
 Peter R. Watson Ph: 252-559-2200
  Statesville
 Iredell Memorial Hospital
 Ruby A. Grimm Ph: 704-873-5661
North Dakota
  Fargo
 Roger Maris Cancer Center at MeritCare Hospital
 Preston D. Steen Ph: 701-234-6161
 Preston D. Steen Ph: 701-234-6161
 Sanford Clinic North-Fargo
 Preston D. Steen Ph: 701-234-6161
Ohio
  Akron
 Summa Center for Cancer Care at Akron City Hospital
 Jennifer E Payne Ph: 330-375-6101
  Cleveland
 Cleveland Clinic Cancer Center at Fairview Hospital
 Anjali S Advani Ph: 866-223-8100
 Cleveland Clinic Taussig Cancer Center
 Anjali S Advani Ph: 866-223-8100
 MetroHealth Cancer Care Center at MetroHealth Medical Center
 Bruce J. Averbook Ph: 216-778-8526
  Email: kbauchens@metrohealth.org
  Columbus
 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
 Kristie A. Blum Ph: 866-627-7616
  Email: osu@emergingmed.com
  Dayton
 CCOP - Dayton
 Howard M. Gross Ph: 317-783-8918
 David L. Rike Cancer Center at Miami Valley Hospital
 Howard M. Gross Ph: 765-983-3000
 Good Samaritan Hospital
 Howard M. Gross Ph: 765-983-3000
  Findlay
 Blanchard Valley Regional Cancer Center
 Howard M. Gross Ph: 317-783-8918
  Franklin
 Atrium Medical Center
 Howard M. Gross Ph: 317-783-8918
  Greenville
 Wayne Hospital
 Howard M. Gross Ph: 317-783-8918
  Kettering
 Charles F. Kettering Memorial Hospital
 Howard M. Gross Ph: 317-783-8918
  Troy
 UVMC Cancer Care Center at Upper Valley Medical Center
 Howard M. Gross Ph: 317-783-8918
Oregon
  Clackamas
 Clackamas Radiation Oncology Center
 Alison K Conlin Ph: 503-215-6412
  Milwaukie
 Providence Milwaukie Hospital
 Alison K Conlin Ph: 503-215-6412
  Newberg
 Providence Newberg Medical Center
 Alison K Conlin Ph: 503-215-6412
  Oregon City
 Willamette Falls Hospital
 Alison K Conlin Ph: 503-215-6412
  Portland
 CCOP - Columbia River Oncology Program
 Alison K Conlin Ph: 503-215-6412
 Providence Cancer Center at Providence Portland Medical Center
 Alison K Conlin Ph: 503-215-6412
 Providence St. Vincent Medical Center
 Alison K Conlin Ph: 503-215-6412
Pennsylvania
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Edward J Gorak Ph: 570-271-5251
  Hazleton
 Geisinger Hazleton Cancer Center
 Edward J Gorak Ph: 570-271-5251
  Philadelphia
 Fox Chase Cancer Center - Philadelphia
 Michael M Millenson Ph: 215-728-4790
  Pottstown
 Pottstown Memorial Regional Cancer Center
 Wei Song Ph: 610-327-7544
  State College
 Geisinger Medical Group - Scenery Park
 Edward J Gorak Ph: 570-271-5251
  Wilkes-Barre
 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
 Edward J Gorak Ph: 570-271-5251
South Carolina
  Anderson
 AnMed Cancer Center
 Charles E Bowers Ph: 800-486-5941
  Greenville
 Bon Secours St. Francis Health System
 Charles E Bowers Ph: 800-486-5941
  Greer
 Gibbs Cancer Center-Pelham
 Charles E Bowers Ph: 800-486-5941
  Spartanburg
 CCOP - Upstate Carolina
 Charles E Bowers Ph: 800-486-5941
 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
 Charles E Bowers Ph: 800-486-5941
Tennessee
  Bristol
 Blue Ridge Medical Specialists, PC
 Asheesh Shipstone Ph: 423-578-8538
  Kingsport
 Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
 Asheesh Shipstone Ph: 423-578-8538
 Kingsport Hematology-Oncology Associates
 Asheesh Shipstone Ph: 423-578-8538
  Nashville
 Vanderbilt-Ingram Cancer Center
 Nishitha Reddy Ph: 800-811-8480
Virginia
  Charlottesville
 University of Virginia Cancer Center
 Michael Eugene Williams Ph: 434-243-6143
  Martinsville
 Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
 Sreedhar Katragadda Ph: 276-666-7827
  Norton
 Southwest Virginia Regional Cancer Center at Wellmonth Health
 Asheesh Shipstone Ph: 423-578-8538
Washington
  Vancouver
 Northwest Cancer Specialists at Vancouver Cancer Center
 Alison K Conlin Ph: 503-215-6412
 Southwest Washington Medical Center Cancer Center
 Alison K Conlin Ph: 503-215-6412
West Virginia
  Morgantown
 Mary Babb Randolph Cancer Center at West Virginia University Hospitals
 Abraham S Kanate Ph: 304-293-2745
  Email: sfilburn@hsc.wvu.edu
Wisconsin
  Antigo
 Langlade Memorial Hospital
 Hamied R. Rezazadeh Ph: 877-405-6866
  Eau Claire
 Center for Cancer Treatment & Prevention at Sacred Heart Hospital
 Ali W. Bseiso Ph: 715-389-4457
 Marshfield Clinic Cancer Care at Regional Cancer Center
 Ali W. Bseiso Ph: 715-389-4457
  Green Bay
 Green Bay Oncology, Limited at St. Mary's Hospital
 Brian L Burnette Ph: 800-432-6049
 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
 Brian L Burnette Ph: 800-432-6049
 St. Mary's Hospital Medical Center - Green Bay
 Brian L Burnette Ph: 800-432-6049
 St. Vincent Hospital Regional Cancer Center
 Brian L Burnette Ph: 800-432-6049
  Johnson Creek
 UW Cancer Center Johnson Creek
 Brad S. Kahl Ph: 877-405-6866
  La Crosse
 Gundersen Lutheran Center for Cancer and Blood
 Kurt Oettel Ph: 608-775-2385
  Email: cancerctr@gundluth.org
  Madison
 University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
 Brad S. Kahl Ph: 877-405-6866
  Manitowoc
 Holy Family Memorial Medical Center Cancer Care Center
 Brian L Burnette Ph: 800-432-6049
  Marinette
 Bay Area Cancer Care Center at Bay Area Medical Center
 Brian L Burnette Ph: 800-432-6049
  Marshfield
 Marshfield Clinic - Marshfield Center
 Ali W. Bseiso Ph: 715-389-4457
 Saint Joseph's Hospital
 Ali W. Bseiso Ph: 715-389-4457
  Milwaukee
 Froedtert Hospital and Medical College of Wisconsin
 Timothy S Fenske Ph: 414-805-4380
  Minocqua
 Marshfield Clinic - Lakeland Center
 Ali W. Bseiso Ph: 715-389-4457
  Mukwonago
 D.N. Greenwald Center
 Timothy R Wassenaar Ph: 262-928-7878
  New Richmond
 Cancer Center of Western Wisconsin
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Oconomowoc
 Regional Cancer Center at Oconomowoc Memorial Hospital
 Timothy R Wassenaar Ph: 262-928-7878
  Oconto Falls
 Green Bay Oncology, Limited - Oconto Falls
 Brian L Burnette Ph: 800-432-6049
  Rhinelander
 Ministry Medical Group at Saint Mary's Hospital
 Ali W. Bseiso Ph: 715-389-4457
 Ali W. Bseiso Ph: 715-389-4457
  Rice Lake
 Marshfield Clinic - Indianhead Center
 Ali W. Bseiso Ph: 715-389-4457
  Sheboygan
 Saint Nicholas Hospital
 Brian L Burnette Ph: 800-432-6049
  Stevens Point
 Marshfield Clinic at Saint Michael's Hospital
 Ali W. Bseiso Ph: 715-389-4457
 Saint Michael's Hospital Cancer Center
 Ali W. Bseiso Ph: 715-389-4457
  Sturgeon Bay
 Green Bay Oncology, Limited - Sturgeon Bay
 Brian L Burnette Ph: 800-432-6049
  Waukesha
 Waukesha Memorial Hospital Regional Cancer Center
 Timothy R Wassenaar Ph: 262-928-7878
  Wausau
 Marshfield Clinic - Wausau Center
 Ali W. Bseiso Ph: 715-389-4457
 University of Wisconcin Cancer Center at Aspirus Wausau Hospital
 Hamied R. Rezazadeh Ph: 877-405-6866
  Weston
 Diagnostic and Treatment Center
 Ali W. Bseiso Ph: 715-389-4457
 Marshfield Clinic - Weston Center
 Ali W. Bseiso Ph: 715-389-4457
 Ministry Saint Clare's Hospital
 Ali W. Bseiso Ph: 715-389-4457
  Wisconsin Rapids
 Marshfield Clinic - Wisconsin Rapids Center
 Ali W. Bseiso Ph: 715-389-4457
Wyoming
  Casper
 Rocky Mountain Oncology
 Benjamin Thomas Marchello Ph: 800-648-6274
  Sheridan
 Welch Cancer Center at Sheridan Memorial Hospital
 Benjamin Thomas Marchello Ph: 800-648-6274

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01415752
ClinicalTrials.gov processed this data on October 17, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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