S0501 Fludarabine, Melphalan, and Donor Stem Cell Transplant Followed By Tacrolimus and Methotrexate in Treating Patients for Relapsed Lymphoma
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring recurrent adult Hodgkin lymphoma, recurrent small lymphocytic lymphoma, recurrent mantle cell lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse large cell lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of lymphoma of 1 of the following types: Diffuse large B-cell lymphoma Follicular lymphoma Grades 1, 2, or 3 Primary mediastinal lymphoma Mantle cell lymphoma Small lymphocytic lymphoma Hodgkin's lymphoma Transformed lymphoma Relapsed after prior autologous bone marrow transplantation (BMT) More than 180 days post BMT Received ≥ 1 course of chemotherapy after BMT relapse Achieved a complete response OR a partial response to chemotherapy Largest residual tumor dimension ≤ 2 cm No clinical or laboratory evidence of CNS involvement by lymphoma HLA-identical donor available, meeting 1 of the following criteria: Sibling donor with 5/6 or 6/6 alleles matching by genotyping No monozygotic identical twins Unrelated donor with 10/10 alleles matching by genotyping PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-2 Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Cardiovascular LVEF ≥ 40% by MUGA or 2-D echocardiogram (2-D ECHO) No significant cardiac abnormalities by MUGA or 2-D ECHO No uncompensated coronary artery disease by ECG or physical exam None of the following within the past 6 months: Myocardial infarction Unstable angina Uncontrolled atrial fibrillation None of the following within the past 3 months: Severe peripheral vascular disease Venous stasis ulcers Deep venous or arterial thrombosis No uncontrolled hypertension Pulmonary DLCO (corrected) and total lung capacity ≥ 40% of predicted No requirement for continuous supplemental oxygen Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No AIDS No active bacterial, viral, or fungal infection No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No history of uncontrolled seizures No diabetic ulcers within the past 3 months PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics No more than 1 prior bone marrow transplantation Chemotherapy See Disease Characteristics More than 21 days since prior chemotherapy and recovered Endocrine therapy Not specified Radiotherapy More than 4 weeks since prior radiotherapy Surgery More than 4 weeks since prior major surgery except placement of a venous access device
Sites / Locations
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Reid Hospital & Health Care Services, Incorporated
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas, PA - Kingman
- Southwest Medical Center
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- Highland Hospital of Rochester
- Interlakes Oncology/Hematology PC
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Blanchard Valley Medical Associates
- Charles F. Kettering Memorial Hospital
- Middletown Regional Hospital
- UVMC Cancer Care Center at Upper Valley Medical Center
- United States Air Force Medical Center - Wright-Patterson
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Arms of the Study
Arm 1
Experimental
Nonmyeloablative allogeneic stem cell transplant
Patients are given fludarabine 30 mg/m^2 on days -6 to -2 and melphalan 70 mg/m^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m^2 on days 1, 3, and 7.