Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have myelodysplastic syndrome.

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

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Busulfan; Cyclophosphamide; Cyclosporine; Cyclosporins; Methotrexate

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of low or intermediate-risk myelodysplastic syndrome

• Refractory anemia (RA)

• RA with ringed sideroblasts

• No advanced myelodysplastic syndrome (i.e., at least 5% blasts in the marrow, more than 1% blasts in the peripheral blood, or blasts in the cerebrospinal fluid)

• No poor-risk cytogenetics (i.e., abnormalities of chromosome 7 or complex abnormalities)

• HLA-A, B, C, DRB1, and DQB1 compatible related or unrelated donor available

• Mismatch for a single HLA-A, B, C, DRB1, or DQB1 allele allowed

PATIENT CHARACTERISTICS:

Age:

• 65 and under

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• AST no greater than 2 times normal

Renal:

• Creatinine no greater than 2 times upper limit of normal

• Creatinine clearance at least 50%

Cardiovascular:

• No cardiac insufficiency requiring treatment

• No symptomatic coronary artery disease

Pulmonary:

• No severe hypoxemia (pO2 less than 70 mm Hg with DLCO less than 70% predicted)

• No mild hypoxemia (pO2 less than 80 mm Hg with DLCO less than 60% predicted)

Other:

• No other disease that would limit life expectancy

• HIV negative

• Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified