Overview

Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia

Status:
Withdrawn
Trial end date:
2007-10-01
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. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating patients with chronic myelogenous leukemia.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Columbia University
Treatments:
Busulfan
Cyclophosphamide
Cyclosporine
Cyclosporins
Cytarabine
Idarubicin
Interferon-gamma
Interferons
Criteria
DISEASE CHARACTERISTICS: Diagnosis of chronic myelogenous leukemia in first chronic phase
Philadelphia chromosome-positive Myelofibrosis less than 3+ on bone marrow biopsy
Ineligible for allogeneic transplantation No suitable allogeneic sibling donor OR Under 55
years old but refuses unrelated donor transplantation or no unrelated donor available

PATIENT CHARACTERISTICS: Age: 18 to physiologic 60 Performance status: ECOG 0-1
Hematopoietic: See Disease Characteristics WBC at least 3,000/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin less than 2 times normal (unless elevation due to Gilbert's
disease) SGOT less than 1.5 times normal Renal: Creatinine less than 1.5 times normal
Cardiovascular: Left ventricular ejection fraction at least 50% Pulmonary: DLCO at least
60% predicted Other: HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior interferon alfa
Chemotherapy: No concurrent conventional chemotherapy Endocrine therapy: No concurrent
steroids during chemotherapy Radiotherapy: Not specified Surgery: Not specified Other: No
concurrent barbiturates or acetaminophen during chemotherapy