Overview

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