Spots Global Cancer Trial Database for Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma
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Trial Identification
Brief Title: Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma
Official Title: Allogeneic Stem Cell Transplantation for Mantle Cell Lymphoma
Study ID: NCT00006747
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by donor peripheral stem cell transplantation in treating patients who have mantle cell lymphoma.
Detailed Description: OBJECTIVES: * Determine the long term disease-free survival of patients with mantle cell lymphoma treated with etoposide, carmustine, melphalan, and cytarabine followed by allogeneic peripheral blood stem cell transplantation. * Determine the incidence of molecular remissions in these patients treated with this regimen. * Correlate the persistence of minimal residual disease with clinical outcome in these patients treated with this regimen. * Determine the effect of donor lymphocytes in patients with progressive disease after treatment with this regimen. OUTLINE: This is a multicenter study. Patients receive carmustine IV over 2 hours on day -6; etoposide IV over 3 hours and cytarabine IV over 1 hour every 12 hours on days -5 to -2 for a total of 8 doses; and melphalan IV over 20-30 minutes on day -1. Patients undergo allogeneic peripheral blood stem cell (PBSC) transplantation on day 0. Patients also receive tacrolimus IV continuously over 24 hours beginning on day -2 and then orally twice daily until day 120 and methotrexate IV over 30 minutes on days 1, 3, and 6 as graft-versus-host disease (GVHD) prophylaxis. Patients receive sargramostim (GM-CSF) IV or subcutaneously daily beginning on day 7 and continuing until blood counts recover. Patients with no active GVHD who have persistent disease on day 150 or progressive disease at any time after PBSC transplantation receive donor lymphocytes IV over 2 hours. Patients may receive additional donor lymphocytes at least 8 weeks later if disease persists. Patients are followed at 6 and 12 months posttransplantation and then annually for 4 years.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Veterans Affairs Medical Center - Birmingham, Birmingham, Alabama, United States
University of California San Diego Cancer Center, La Jolla, California, United States
Veterans Affairs Medical Center - San Francisco, San Francisco, California, United States
UCSF Cancer Center and Cancer Research Institute, San Francisco, California, United States
CCOP - Christiana Care Health Services, Wilmington, Delaware, United States
Lombardi Cancer Center, Washington, District of Columbia, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
CCOP - Mount Sinai Medical Center, Miami Beach, Florida, United States
University of Illinois at Chicago, Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Veterans Affairs Medical Center - Togus, Togus, Maine, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center - University Campus, Worcester, Massachusetts, United States
Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota, United States
University of Minnesota Cancer Center, Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia, Missouri, United States
Ellis Fischel Cancer Center - Columbia, Columbia, Missouri, United States
Barnes-Jewish Hospital, Saint Louis, Missouri, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Norris Cotton Cancer Center, Lebanon, New Hampshire, United States
Veterans Affairs Medical Center - Buffalo, Buffalo, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
CCOP - North Shore University Hospital, Manhasset, New York, United States
North Shore University Hospital, Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
New York Presbyterian Hospital - Cornell Campus, New York, New York, United States
Mount Sinai Medical Center, NY, New York, New York, United States
State University of New York - Upstate Medical University, Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse, Syracuse, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York, United States
Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States
Veterans Affairs Medical Center - Durham, Durham, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
CCOP - Southeast Cancer Control Consortium, Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States
Rhode Island Hospital, Providence, Rhode Island, United States
University of Tennessee Cancer Institute, Memphis, Tennessee, United States
Veterans Affairs Medical Center - Memphis, Memphis, Tennessee, United States
Green Mountain Oncology Group, Bennington, Vermont, United States
Vermont Cancer Center, Burlington, Vermont, United States
Veterans Affairs Medical Center - White River Junction, White River Junction, Vermont, United States
Veterans Affairs Medical Center - Richmond, Richmond, Virginia, United States
MBCCOP - Massey Cancer Center, Richmond, Virginia, United States
Contact Details
Name: Koen Van Besien, MD
Affiliation: University of Chicago
Role: STUDY_CHAIR
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