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Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma Clinical research trials and Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma  Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma
For Condition: stage 1 mantle cell lymphoma,recurrent mantle cell lymphoma,stage 4 mantle cell lymphoma,contiguous stage 2 mantle cell lymphoma,stage 3 mantle cell lymphoma,Graft Versus Host Disease,noncontiguous stage 2 mantle cell lymphoma
Status: No longer recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 3.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /59 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed mantle cell lymphoma of any stage with at least 1 of the following: - Immunophenotype with expression of CD5 and CD19 and absence of CD23 - Cytogenetic analysis with presence of t(11;14) - Overexpression of cyclin D1 - Rearrangement of BCL1 gene - Bone marrow biopsy required - No needle or core biopsy as sole means of diagnosis - First remission allowed if at least 1 of the following poor prognostic characteristics present: - International Prognostic Index (IPI) score higher than 1 defined by the following risk factors: - Performance status higher than 1 - Elevated LDH - Presence of more than 1 extranodal site - Stage III or IV disease - Blastic variant of mantle cell lymphoma* - Complex karyotypes (i.e., cytogenetic abnormalities different from or in addition to t(11;14)* - Proliferative index more than 10%* - Presence of p53 mutations NOTE: *Regardless of IPI score - Failure of initial therapy with anthracycline-containing regimen allowed - Failure to achieve clinical complete remission after initial therapy OR - Recurrent disease after initial therapy - HLA matched (6/6) sibling donor by serologic typing (A, B, or DR) - Any age - No syngeneic (identical twin) donor - No active CNS lymphoma PATIENT CHARACTERISTICS: Age: - Under 60 Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Bilirubin less than 2 mg/dL - AST and ALT no greater than 3 times upper limit of normal Renal: - Creatinine less than 2 mg/dL Pulmonary: - DLCO at least 40% - No symptomatic pulmonary disease Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior bone marrow transplantation Chemotherapy: - See Disease Characteristics - No more than 2 prior chemotherapy regimens - No other concurrent chemotherapy Endocrine therapy: - No concurrent hormonal therapy Radiotherapy: - No concurrent radiotherapy to bulky sites Surgery: - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KoenBesien, Study Chair, University of Illinois
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104
United States
Green Mountain Oncology Group
Bennington, Vermont, 05201
United States
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, 35233-1996
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
University of Tennessee Cancer Institute
Memphis, Tennessee, 38103
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
University of Illinois at Chicago
Chicago, Illinois, 60612
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Veterans Affairs Medical Center - Togus
Togus, Maine, 04330
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Additional Information:
Study ID Numbers: CDR0000068324; CLB-59908
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006747
Other Graft Versus Host Disease Studies:
1. Chemotherapy Followed by Radiation Therapy and Peripheral Stem Cell Transplantation Compared With Chemotherapy Plus Interferon Alfa in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma
2. Chemotherapy Plus Rituximab in Treating Patients With Mantle Cell Lymphoma
3. Rituximab and Cladribine in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma
4. Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma
5. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma
Related Studies:
Other Graft Versus Host Disease Clinical Trials
Other Delaware Clinical Trials
Other Wilmington Clinical Trials
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma
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