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Clinical Trials (PDQ®)

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, NCI-2011-02980, 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.
Colorado
  Aurora
 Medical Center of Aurora - South Campus
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Aurora
 Keren Sturtz Ph: 888-785-6789
  Boulder
 Boulder Community Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers-Boulder
 Keren Sturtz Ph: 888-785-6789
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers at the Pavilion
 Keren Sturtz Ph: 888-785-6789
  Denver
 CCOP - Colorado Cancer Research Program
 Keren Sturtz Ph: 888-785-6789
 Colorado Blood Cancer Institute
 Keren Sturtz Ph: 888-785-6789
 Porter Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Presbyterian - St. Luke's Medical Center
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Denver Midtown
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers-Rose
 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
 Keren Sturtz Ph: 888-785-6789
  Englewood
 Comprehensive Cancer Care and Research Institute of Colorado LLC
 Keren Sturtz Ph: 888-785-6789
 Swedish Medical Center
 Keren Sturtz Ph: 888-785-6789
  Golden
 Mountain Blue Cancer Care Center
 Keren Sturtz Ph: 888-785-6789
  Greeley
 North Colorado Medical Center
 Keren Sturtz Ph: 888-785-6789
  Greenwood Village
 Breast Cancer Care Consultants
 Keren Sturtz Ph: 888-785-6789
  Lakewood
 Rocky Mountain Cancer Centers-Lakewood
 Keren Sturtz Ph: 888-785-6789
 St. Anthony Central Hospital
 Keren Sturtz Ph: 888-785-6789
  Littleton
 Littleton Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Littleton
 Keren Sturtz Ph: 888-785-6789
  Lone Tree
 Rocky Mountain Cancer Centers - Lone Tree
 Keren Sturtz Ph: 888-785-6789
 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
 Rocky Mountain Cancer Centers - Longmont
 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
 Rocky Mountain Cancer Centers - Parker
 Keren Sturtz Ph: 888-785-6789
  Pueblo
 Rocky Mountain Cancer Centers - Pueblo
 Keren Sturtz Ph: 888-785-6789
 St. Mary - Corwin Regional Medical Center
 Keren Sturtz Ph: 888-785-6789
  Thornton
 Rocky Mountain Cancer Centers - Thornton
 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: 734-712-4673
Delaware
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 Gregory A. Masters Ph: 302-733-6227
  Newark
 Christiana Gynecologic Oncology, LLC
 Gregory A. Masters Ph: 302-733-6227
 Delaware Clinical and Laboratory Physicians
 Gregory A. Masters Ph: 302-733-6227
 Helen F. Graham Cancer Center at Christiana Hospital
 Gregory A. Masters Ph: 302-733-6227
 Gregory A. Masters Ph: 302-733-6227
 Medical Oncology Hematology Consultants, PA at Helen F. Graham Cancer Center
 Gregory A. Masters Ph: 302-733-6227
 Regional Hematology/Oncology, PA - Newark
 Gregory A. Masters Ph: 302-733-6227
  Rehoboth Beach
 Beebe Health Campus
 Gregory A. Masters Ph: 302-733-6227
  Seaford
 Nanticoke Memorial Hospital
 Gregory A. Masters Ph: 302-733-6227
  Wilmington
 Christiana Care Health System-Wilmington Hospital
 Gregory A. Masters Ph: 302-733-6227
District of Columbia
  Washington
 Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
 Bruce David Cheson Ph: 202-444-0381
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Christopher M Reynolds Ph: 734-712-4673
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
  Highland Park
 Hematology Oncology Associates of Illinois-Highland Park
 Jane N. Winter Ph: 312-695-1301
  Email: cancer@northwestern.edu
  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
  Niles
 Cancer Care and Hematology Specialists of Chicagoland - Niles
 Jane N. Winter Ph: 312-695-1301
  Email: cancer@northwestern.edu
  Skokie
 Hematology Oncology Associates - Skokie
 Jane N. Winter Ph: 312-695-1301
  Email: cancer@northwestern.edu
Indiana
  Richmond
 Reid Hospital & Health Care Services
 Howard M. Gross Ph: 937-775-1350
Iowa
  Ames
 McFarland Clinic, PC
 Joseph James Merchant Ph: 515-239-2621
 William R. Bliss Cancer Center at Mary Greeley Medical Center
 Joseph James Merchant Ph: 515-239-2621
  Boone
 McFarland Clinic PC-Boone
 Joseph James Merchant Ph: 515-239-2621
  Cedar Rapids
 Cedar Rapids Oncology Associates
 Deborah W Wilbur Ph: 319-363-2690
 Mercy Regional Cancer Center at Mercy Medical Center
 Deborah W Wilbur Ph: 319-363-2690
  Fort Dodge
 Trinity Regional Medical Center
 Joseph James Merchant Ph: 515-239-2621
  Jefferson
 McFarland Clinic PC-Jefferson
 Joseph James Merchant Ph: 515-239-2621
  Marshalltown
 McFarland Clinic PC-Marshalltown
 Joseph James Merchant Ph: 515-239-2621
  Sioux City
 Siouxland Hematology-Oncology Associates, LLP
 Donald Bruce Wender Ph: 712-252-0088
Kentucky
  Crestview Hills
 Oncology Hematology Care, Incorporated - Crestview Hills
 Howard M. Gross Ph: 937-775-1350
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
Massachusetts
  Boston
 Tufts Medical Center Cancer Center
 Andrew M Evens Ph: 617-636-5000
  Email: ContactUsCancerCenter@TuftsMedicalCenter.org
Michigan
  Ann Arbor
 Saint Joseph Mercy Cancer Center
 Christopher M Reynolds Ph: 734-712-4673
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Christopher M Reynolds Ph: 734-712-4673
  Detroit
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Christopher M Reynolds Ph: 734-712-4673
  Flint
 Genesys Hurley Cancer Institute
 Christopher M Reynolds Ph: 734-712-4673
 Hurley Medical Center
 Christopher M Reynolds Ph: 734-712-4673
  Jackson
 Gayle M. Jacob Cancer Center at Allegiance Health
 Christopher M Reynolds Ph: 734-712-4673
  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: 734-712-4673
  Livonia
 St. Mary Mercy Hospital
 Christopher M Reynolds Ph: 734-712-4673
  Pontiac
 St. Joseph Mercy Oakland
 Christopher M Reynolds Ph: 734-712-4673
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Christopher M Reynolds Ph: 734-712-4673
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Christopher M Reynolds Ph: 734-712-4673
  Warren
 St. John Macomb Hospital
 Christopher M Reynolds Ph: 734-712-4673
Minnesota
  Duluth
 CCOP - Duluth
 Bret E Friday Ph: 888-203-7267
 Essentia Health - Duluth Clinic
 Bret E Friday Ph: 888-203-7267
 Miller - Dwan Medical Center
 Bret E Friday Ph: 888-203-7267
  Rochester
 Mayo Clinic Cancer Center
 David James Inwards Ph: 507-538-7623
New York
  Rochester
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Jonathan W Friedberg Ph: 585-275-5830
North Carolina
  Winston-Salem
 Wake Forest University Comprehensive Cancer Center
 Zanetta S Lamar Ph: 336-713-6771
Ohio
  Beachwood
 Cleveland Clinic Taussig Cancer Center
 Anjali S Advani Ph: 866-223-8100
  Cincinnati
 Oncology Hematology Care Inc - Western Hills
 Howard M. Gross Ph: 937-775-1350
 Oncology Hematology Care, Incorporated - Anderson
 Howard M. Gross Ph: 937-775-1350
 Oncology Hematology Care, Incorporated - Blue Ash
 Howard M. Gross Ph: 937-775-1350
 Oncology Hematology Care, Incorporated - Kenwood
 Howard M. Gross Ph: 937-775-1350
 Oncology Hematology Care, Incorporated - Mt. Auburn/Taft Road
 Howard M. Gross Ph: 937-775-1350
  Cleveland
 Case Comprehensive Cancer Center
 Paolo F Caimi Ph: 800-641-2422
 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
  Dayton
 David L. Rike Cancer Center at Miami Valley Hospital
 Howard M. Gross Ph: 937-775-1350
 Good Samaritan Hospital
 Howard M. Gross Ph: 937-775-1350
 Samaritan North Cancer Care Center
 Howard M. Gross Ph: 937-775-1350
  Elyria
 Mercy Cancer Center - Elyria
 Paolo F Caimi Ph: 800-641-2422
  Fairfield
 Oncology Hematology Care, Incorporated - Fairfield Healthplex
 Howard M. Gross Ph: 937-775-1350
  Findlay
 Blanchard Valley Regional Cancer Center
 Howard M. Gross Ph: 937-775-1350
  Franklin
 Atrium Medical Center
 Howard M. Gross Ph: 937-775-1350
  Greenville
 Wayne Hospital
 Howard M. Gross Ph: 937-775-1350
  Independence
 Cleveland Clinic Taussig Cancer Center
 Anjali S Advani Ph: 866-223-8100
  Kettering
 Charles F. Kettering Memorial Hospital
 Howard M. Gross Ph: 937-775-1350
  Mayfield Heights
 Hillcrest Cancer Center at Hillcrest Hospital
 Anjali S Advani Ph: 866-223-8100
  Mentor
 Lake/University Ireland Cancer Center
 Paolo F Caimi Ph: 800-641-2422
  Sandusky
 North Coast Cancer Care, Incorporated
 Anjali S Advani Ph: 866-223-8100
  Strongsville
 Cleveland Clinic Foundation - Strongsville
 Anjali S Advani Ph: 866-223-8100
  Troy
 UVMC Cancer Care Center at Upper Valley Medical Center
 Howard M. Gross Ph: 937-775-1350
  Westlake
 UH-Seidman Cancer Center at Saint John Medical Center
 Paolo F Caimi Ph: 800-641-2422
  Wooster
 Cleveland Clinic - Wooster
 Anjali S Advani Ph: 866-223-8100
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
  Lewisburg
 Geisinger Medical Oncology at Evangelical Community Hospital
 Edward J Gorak Ph: 570-271-5251
  Lewistown
 Lewistown Hospital
 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
  Pottsville
 Geisinger Medical Oncology-Pottsville
 Edward J Gorak Ph: 570-271-5251
  State College
 Geisinger Medical Group - Scenery Park
 Edward J Gorak Ph: 570-271-5251
  West Reading
 McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
 Terrence P. Cescon Ph: 610-988-9323
  Wilkes-Barre
 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
 Edward J Gorak Ph: 570-271-5251
South Carolina
  Greer
 Gibbs Cancer Center-Pelham
 Charles E Bowers Ph: 800-486-5941
  Spartanburg
 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
 Charles E Bowers Ph: 800-486-5941
Virginia
  Charlottesville
 University of Virginia Cancer Center
 Michael Eugene Williams Ph: 434-243-6143
Wisconsin
  Antigo
 Langlade Memorial Hospital
 Hamied R. Rezazadeh Ph: 877-405-6866
  Milwaukee
 Froedtert Hospital and Medical College of Wisconsin
 Timothy S Fenske Ph: 414-805-4380
  Wausau
 University of Wisconcin Cancer Center at Aspirus Wausau Hospital
 Hamied R. Rezazadeh Ph: 877-405-6866

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01415752
ClinicalTrials.gov processed this data on November 12, 2014

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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