S0501 Fludarabine, Melphalan, and Donor Stem Cell Transplant Followed By Tacrolimus and Methotrexate in Treating Patients for Relapsed Lymphoma

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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 the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and methotrexate after transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well giving fludarabine together with melphalan followed by tacrolimus and methotrexate works in treating patients who are undergoing a donor stem cell transplant for relapsed lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Fludarabine; Fludarabine phosphate; Melphalan; Methotrexate; Tacrolimus

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