Overview

Total-Body Irradiation and Cyclophosphamide in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer and Other Diseases

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Giving total-body irradiation and chemotherapy, such as cyclophosphamide, before a donor stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells and helps stop the growth of cancer or abnormal 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 immunosuppressive therapy before or after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving total-body irradiation together with cyclophosphamide works in treating patients who are undergoing donor stem cell transplant for hematologic cancer and other diseases.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fred Hutchinson Cancer Research Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Cyclophosphamide
Cyclosporine
Cyclosporins
Methotrexate
Mycophenolate mofetil
Mycophenolic Acid
Sirolimus
Tacrolimus
Criteria
DISEASE CHARACTERISTICS:

- Diagnosis of a hematologic cancer or other disease that is unlikely to respond to
conventional treatment, including any of the following:

- Chronic myelogenous leukemia

- Acute myeloid leukemia

- Acute lymphocytic leukemia

- Myelodysplastic syndromes

- Lymphoma

- Patients who have bulky tumor mass must not require additional involved-field
irradiation

- Planning to undergo conditioning for transplantation at the Seattle Cancer Care
Alliance and University of Washington Medical Center

- Must have an HLA-matched donor available

- No donors who are mismatched for > 1 HLA class I antigen or allele

- Negative anti-donor lymphocytotoxic crossmatch

PATIENT CHARACTERISTICS:

- Life expectancy must not be severely limited by diseases other than malignancy

- No moribund patients

- Creatinine ≤ 1.2 mg/dL

- Oxygen saturation on room air ≥ 93%

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No HIV positivity

- No cirrhosis

- No hepatic fibrosis with bridging

- No fulminant hepatic failure

- No acute liver injury

- No persistent cholestasis

- No infection requiring systemic antibiotic or antifungal therapy

- No coronary artery disease

- No congestive heart failure requiring therapy

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior hematopoietic stem cell transplantation

- No prior radiation therapy to the liver or adjacent organs

- More than 30 days since prior cytoreductive chemotherapy for patients with a large
body burden of tumor cells

- No concurrent enrollment in a phase I study