Total-Body Irradiation, Thiotepa, and Fludarabine in Treating Young Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Chemotherapy, such as fludarabine and thiotepa, and radiation therapy may destroy cancerous blood-forming cells (stem cells) in the blood and bone marrow. Giving healthy stem cells from a donor whose blood closely resembles the patient's blood will help the patient's bone marrow make new stem cells that become red blood cells, white blood cells, and platelets.

PURPOSE: This phase I/II trial is studying the side effects of total-body irradiation, fludarabine, and thiotepa and to see how well they work in treating young patients who are undergoing a donor stem cell transplant for hematologic cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Fludarabine; Fludarabine phosphate; Thiotepa; Vidarabine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of a life-threatening hematologic malignancy, including any of the following:

• Acute leukemia advanced beyond first remission

• Acute leukemia in first remission* with very high-risk prognostic features, including any of the following:

• Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL)

• ALL or acute myeloid leukemia (AML) with 11q23 chromosomal abnormality

• Hypodiploid ALL

• Failed to achieve first remission within 1 month after induction therapy

• Secondary AML

• Myelodysplastic syndromes with International Prognostic Index score > 1

• Chronic myelogenous leukemia in accelerated or blast phase NOTE: *Must be approved by PCC

• Haploidentical family donor available

• No suitable HLA-matched related or unrelated donor available

• No related donor mismatched for a single HLA-A, -B, -C, -DRB1, or -DQB1 antigen available

PATIENT CHARACTERISTICS:

Age

• Under 21

Performance status

• Not specified

Life expectancy

• At least 6 months

Hematopoietic

• Not specified

Hepatic

• SGPT and SGOT < 2 times upper limit of normal (ULN)*

• Bilirubin < 2 times ULN* NOTE: *Unless due to malignancy

Renal

• Not specified

Cardiovascular

• Ejection fraction ≥ 45%

Pulmonary

• DLCO ≥ 60% of predicted

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No second bone marrow transplantation, after a first regimen containing total body irradiation

• No concurrent growth factors until day 21 post-transplantation

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• See Biologic therapy

Surgery

• Not specified