RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Colony-stimulating factors such as sargramostim 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 therapy. Combining sargramostim with interferon alfa may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of sargramostim in treating patients who are receiving interferon alfa for chronic phase chronic myelogenous leukemia that is in remission.

Condition	Treatment or Intervention	Phase
Philadelphia chromosome positive chronic myelogenous leukemia chronic phase chronic myelogenous leukemia Philadelphia chromosome negative chronic myelogenous leukemia	Drug: interferon alfa  Drug: sargramostim	Phase II

Further Study Details: 

OBJECTIVES: I. Estimate the rate of major cytogenetic responses to sargramostim (GM-CSF) and interferon alfa in patients with newly diagnosed chronic phase chronic myeloid leukemia. II. Estimate the dosing, schedule, and toxic effects of GM-CSF plus interferon alfa in these patients.

PROTOCOL OUTLINE: All patients are in hematologic remission on subcutaneous interferon alfa upon entering the study. Once a complete hematologic response is achieved and the interferon alfa dose has been stable for 14 days, patients receive subcutaneous sargramostim (GM-CSF) daily for 6 months. Patients are followed at 3, 6, 9, and 12 months.

PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Cytogenetically or molecularly proven chronic phase chronic myeloid leukemia (CML) that is Philadelphia chromosome positive OR Philadelphia chromosome negative with evidence of the BCR-ABL rearrangement or evidence of the P120 protein; On interferon alfa therapy less than 6 months
• In complete hematologic response, defined as: WBC less than 10,000/mm3; Platelet count less than 450,000/mm3; Less than 5% circulating blasts; No signs and symptoms of disease, including progressive splenomegaly

--Prior/Concurrent Therapy--

• Biologic therapy: Prior interferon alfa required
• Chemotherapy: Prior hydroxyurea and cytarabine allowed
• Endocrine therapy: Not specified
• Radiotherapy: Not specified
• Surgery: Not specified
• Other: No other concurrent myelosuppressive drug therapy

--Patient Characteristics--

• Age: 18 and over
• Performance status: Not specified
• Life expectancy: Not specified
• Hematopoietic: See Disease Characteristics
• Hepatic: Not specified
• Renal: Not specified
• Other: Not pregnant or nursing; Fertile patients must use effective contraception; No history of intolerance to sargramostim (GM-CSF); Must be able to perform self injection

Maryland
      Johns Hopkins Oncology Center, Baltimore,  Maryland,  21231-2410,  United States

Study chairs or principal investigators

Richard J. Jones,  Study Chair,  Johns Hopkins Oncology Center   

Study ID Numbers:  CDR0000066625; JHOC-98011606; NCI-V98-1468; JHOC-9806
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003561
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08