Overview
High-Dose Chemotherapy Followed by Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
Status:
Completed
Completed
Trial end date:
2002-09-01
2002-09-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy and radiation therapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of high-dose combination chemotherapy followed by total-body irradiation and peripheral stem cell transplantation in treating patients with chronic lymphocytic leukemia.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Fred Hutchinson Cancer Research CenterCollaborator:
National Cancer Institute (NCI)Treatments:
Cyclophosphamide
Dexamethasone
Etoposide
Criteria
DISEASE CHARACTERISTICS: Diagnostically proven intermediate, advanced, or high risk chroniclymphocytic leukemia of the B cells with marrow tumor reduced by prior therapy Marrow tumor
content no greater than 30% of total nucleated cells Patients age 50 and under who have
high risk disease are eligible Patients age 65 and under who have intermediate or high risk
disease that has failed at least 1 therapy including an alkylating agent or fludarabine are
eligible No history of transformation to aggressive lymphoma (Richter's syndrome)
PATIENT CHARACTERISTICS: Age: 17 to 65 Performance status: Karnofsky 70%-100% Life
expectancy: Not severely limited by illness other than leukemia Hematopoietic: Absolute
neutrophil count greater than 2,000/mm3 (no growth factor support) Platelet count greater
than 120,000/mm3 (unless documented active autoimmune thrombocytopenia) Hemoglobin greater
than 10 g/dL (unless documented active autoimmune anemia) No coexisting myelodysplasia
Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine clearance at least 50 mL/min
Cardiovascular: No cardiac disease that would limit ability to receive cytoreductive
therapy and compromise survival Pulmonary: No pulmonary disease that would limit ability to
receive cytoreductive therapy and compromise survival Other: No HIV antibody Not pregnant
PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior radiation therapy to chest
or abdomen greater than 2,000 Gy