Overview

Chemotherapy Followed by Peripheral Stem Cell Transplantation And Biological Therapy in Treating Patients With Chronic Myelogenous Leukemia

Status:
Completed

Trial end date:
2001-10-01

Target enrollment:
0

Participant gender:
All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. 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 and biological therapy in treating patients who have chronic myelogenous leukemia.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Fred Hutchinson Cancer Research Center

Collaborator:

National Cancer Institute (NCI)

Treatments:

Aldesleukin
Busulfan
Interferon-alpha
Interferons
Sargramostim

Criteria

DISEASE CHARACTERISTICS: Chronic myelogenous leukemia with previously stored CD34 cells
from FHCRC-928.00 Chronic phase: No evidence of a major response after 6-month course of
interferon alfa OR Initially achieved a major cytogenetic response but subsequently failed
interferon alfa OR Accelerated phase: At least 1 month after collection of peripheral blood
stem cells No blast crisis No CNS involvement Ineligible for or refused allogeneic
conventional or minitransplant protocol

PATIENT CHARACTERISTICS: Age: 70 and under Performance status: Karnofsky 80-100% Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than
2.0 mg/dL (unless history of Gilbert's disease) AST or ALT no greater than 2.5 times upper
limit of normal No cirrhosis Hepatitis B and C negative Renal: Creatinine no greater than
2.0 mg/dL Cardiovascular: No myocardial infarction within past 12 months No unstable
angina, poorly controlled arrhythmias, or hypertension LVEF greater than 50% Pulmonary:
DLCO at least 50% Alveolar arterial gradient less than 30 at sea level Other: Not pregnant
or nursing Negative pregnancy test Fertile patients must use effective contraception HIV
negative No active infection requiring systemic antibiotics No known allergy to gentamicin
or murine or E. coli proteins or documented prior anaphylactic reaction to sargramostim
(GM-CSF) or interleukin-2

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: Not
specified Endocrine therapy: No concurrent ongoing steroids Radiotherapy: Not specified
Surgery: Not specified