Donor Stem Cell Transplant or Donor White Blood Cell Infusions in Treating Patients With Hematologic Cancer

• Status: Terminated
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: A peripheral stem cell transplant or an umbilical cord blood transplant from a donor may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) after the transplant may help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells can make an immune response against the body's normal cells. Methotrexate, cyclosporine, tacrolimus, or methylprednisolone may stop this from happening.

PURPOSE: This clinical trial is studying how well a donor stem cell transplant or donor white blood cell infusions work in treating patients with hematologic cancer.

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

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antilymphocyte Serum; Busulfan; Carmustine; Cyclophosphamide; Cyclosporine; Cyclosporins; Cytarabine; Etoposide; Etoposide phosphate; Fludarabine; Fludarabine phosphate; Melphalan; Methotrexate; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Mycophenolate mofetil; Mycophenolic Acid; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Tacrolimus; Vidarabine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following*:

• Acute lymphoblastic leukemia in any disease phase

• Patients with any of the following high-risk features are encouraged to enroll:

• Philadelphia chromosome positive disease

• L3 morphology, especially in the presence of t(8;14), t(8;22), or t(2;8)

• Patients not in remission at day 28 of first induction

• High LDH (i.e., ≥ 300 IU/mL at presentation)

• Pre-B-cell, mixed lineage, or Burkitt's markers

• Relapsed in the marrow while receiving continuous chemotherapy

• Within 6 months after stopping chemotherapy

• Relapse in one organ or extramedullary relapses in more than one organ while still receiving chemotherapy

• Hodgkin's or non-Hodgkin's lymphoma beyond first complete remission (CR) or in first CR with features of high-risk disease, including, but not limited to:

• Lymphoma not in CR after 3 courses of primary therapy

• Patients with bulky disease at presentation, especially bulky mediastinal disease

• Patients with LDH ≥ 300 IU/mL at presentation

• Patients with extranodal disease

• Patients with first remission within less than 1 year

• Stage IV disease at presentation, especially with marrow involvement

• Patients with high-intermediate or high International Index Scores

• Acute myeloid leukemia (AML) meeting the following criteria:

• Beyond first remission or high-risk disease in first CR

• Required multiple courses of induction therapy to achieve a remission

• Had residual leukemia on day 14-28 bone marrow examination after initial induction

• Patients with any cytogenetic abnormality except inv 16 or t(8;21)

• Chronic myelogenous leukemia in the chronic or early accelerated phase of the disease

• Patients with blast crisis that can be induced back into chronic phase may be transplanted in second chronic phase

• Myelodysplastic syndromes (MDS) meeting the following requirements:

• Transfusion-dependent refractory anemia (RA), RA with excess blasts (RAEB), RAEB in transformation, or chronic myelomonocytic leukemia (CMML)

• Patients with MDS that present with or evolve to AML must be re-induced back to remission prior to initiating a search for an unrelated donor NOTE: *Patients with other hematologic malignancies not listed above, including diseases such as chronic lymphocytic leukemia (CLL), multiple myeloma, or rare pediatric malignancies, or patients who are felt to be at high-risk for relapse but who do not have features listed, may be allowed at the discretion of the investigator.

• Must have failed prior stem cell transplantation

• Must have a suitable unrelated allogeneic hematopoietic stem cell donor

• A 5/6 match degree is acceptable for unrelated bone marrow donors

• A 4/6 match degree is acceptable for unrelated cord blood units

PATIENT CHARACTERISTICS:

• SWOG performance status (PS) 0-2 OR

• Karnofsky PS 50-100% OR

• Lansky PS 50-100%

• Creatinine clearance ≥ 45 mL/min

• Creatinine ≤ 2.5 mg/dL

• Bilirubin ≤ 2 mg/dL (abnormally high liver function tests allowed if the only source for the elevation is due to lymphoma of the liver)

• AST or ALT ≤ 2 times normal (abnormally high liver function tests allowed if the only source for the elevation is due to lymphoma of the liver)

• No patients at high risk of veno-occlusive disease

• Not pregnant or nursing

• Negative serum pregnancy test

• Fertile patients must use an effective contraceptive method

• DLCO ≥ 50% of predicted

• FEV_1/FVC ≥ 65% of predicted

• No current congestive heart failure (CHF) and/or LVEF ≥ 45%

• No myocardial infarction within the past 6 months

• No unstable angina within the past 6 months

• HIV negative

• Life expectancy must not be limited by disease other than malignancy

• No allergy to any chemotherapeutic agent included in the regimen

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics