Status:
TERMINATED
S0501 Fludarabine, Melphalan, and Donor Stem Cell Transplant Followed By Tacrolimus and Methotrexate in Treating Patients for Relapsed Lymphoma
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving low doses of chemotherapy, such as fludarabine and melphalan, before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops...
Detailed Description
OBJECTIVES: * Determine the 1-year progression-free and overall survival rate in patients with relapsed Hodgkin's or non-Hodgkin's lymphoma after prior autologous stem cell transplantation treated wi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00121186
Start Date
July 1 2005
End Date
December 1 2011
Last Update
April 3 2012
Active Locations (33)
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1
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
2
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
3
Reid Hospital & Health Care Services, Incorporated
Richmond, Indiana, United States, 47374
4
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720