Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematologic Cancer

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and etoposide, before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and tacrolimus and prednisone after transplant may stop this from happening.

PURPOSE: This phase I trial is studying how well donor umbilical cord blood transplant works in treating patients with advanced hematologic cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antilymphocyte Serum; Busulfan; Etoposide; Fludarabine; Fludarabine phosphate; Prednisone; Sargramostim; Tacrolimus

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following advanced hematologic malignancies:

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

• Not expected to be curable with chemotherapy and meets ≥ 1 of the following criteria:

• High-risk cytogenetics (-7, -7q, -5, -5q, t[6,9], t[9,11], complex, Philadelphia chromosome positive [Ph+])

• AML evolved from prior myelodysplasia

• AML secondary to prior chemotherapy

• Failed to achieve remission

• In second or subsequent remission

• Marrow blasts ≤ 10% (may be achieved using chemotherapy)

• Myelodysplastic syndromes (MDS) with high-risk features

• International Prognostic Scoring System (IPSS) score intermediate -2 or high-risk

• Marrow blasts ≤ 20% (may be achieved using chemotherapy)

• Acute lymphoblastic leukemia meeting the following criteria:

• Not expected to be curable with chemotherapy and meets ≥ 1 of the following criteria:

• High-risk cytogenetics (Ph+, t[4,11], 11q23 abnormalities, and monosomy 7)

• Required > 1 induction course to achieve remission

• Failed to achieve remission

• In second or subsequent remission

• Marrow blasts ≤ 10% (may be achieved using chemotherapy)

• Chronic myelogenous leukemia meeting ≥ 1 of the following criteria:

• Accelerated phase

• Chronic phase refractory to imatinib mesylate

• Blastic phase

• Marrow blasts ≤ 10% (may be achieved using chemotherapy)

• Multiple myeloma meeting 1 of the following criteria:

• Stage II or III disease with > first relapse or refractory disease

• Newly diagnosed disease with chromosome 13 abnormalities

• Lymphoma meeting the following criteria:

• One of the following subtypes:

• Diffuse large cell lymphoma

• Mantle cell lymphoma

• Peripheral T-cell lymphoma

• T-natural killer (NK) cell lymphoma

• Hodgkin's lymphoma

• Disease failed to respond to primary therapy, progressed, or recurred after prior therapy

• Patients who have failed autologous stem cell transplantation are eligible provided it has been > 1 year since transplant

• No rapid progression of malignant disease

• Not eligible for autologous stem cell transplantation

• Available umbilical cord blood (1-3 units) donor matching at ≥ 4 of 6 HLA antigens (A, B, and DR)

• Patients with an HLA-identical or 1 antigen-mismatched related donor OR a potential HLA-matched unrelated donor matching at > 6/8 (A, B, C, DR) alleles are not eligible

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Creatinine < 2.0 mg/dL

• Creatinine clearance > 40 mL/min

• Bilirubin < 2.0 mg/dL

• AST and alkaline phosphatase < 3 times upper limit of normal

• Hepatitis C and active hepatitis B allowed if patient has ≤ grade 2 inflammation or fibrosis by liver biopsy

• Ejection fraction > 40% by echocardiogram or MUGA

• DLCO > 40% of predicted

• Not pregnant or nursing

• Negative pregnancy test

• No known HIV infection

• No active infection requiring ongoing antibiotic treatment

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics