Overview

Chemotherapy, Filgrastim and Peripheral Stem Cell Transplantation in Patients With Chronic Myelogenous Leukemia

Status:
Terminated
Trial end date:
1969-12-31
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. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of chemotherapy and filgrastim followed by peripheral stem cell transplantation in treating patients who have chronic myelogenous leukemia.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Treatments:
Busulfan
Cyclophosphamide
Interferon-alpha
Interferons
Lenograstim
Criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed chronic or accelerated phase chronic myelogenous leukemia

- Philadelphia chromosome positive OR

- BCR/ABL rearrangement

- No blast crisis or post blast crisis

- No moderate to severe fibrosis defined by bilateral trephine biopsies

- Not eligible for or refused to participate in allogeneic marrow transplant protocols

- No splenomegaly (below umbilicus) that does not respond to chemotherapy and/or
radiotherapy

PATIENT CHARACTERISTICS:

Age:

- 18 to 65

Performance status:

- Karnofsky 90-100%

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- Normal organ function (except bone marrow)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Prior interferon alfa allowed

Chemotherapy:

- Prior hydroxyurea allowed

- At least 2 months since prior busulfan (at time of PBSC harvest)

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified