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Interferon Alfa Plus Sargramostim in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003561
First Posted: March 22, 2004
Last Update Posted: July 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
November 1, 1999
March 22, 2004
July 20, 2011
February 1998
October 2001   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00003561 on ClinicalTrials.gov Archive Site
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Interferon Alfa Plus Sargramostim in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
Granulocyte-Macrophage Colony Stimulating Factor (Rhu-GM-CSF) With Interferon-Alpha (IFN-alpha) for Chronic Myeloid Leukemia

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.

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Leukemia
  • Biological: recombinant interferon alfa
  • Biological: sargramostim
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
48
August 2010
October 2001   (Final data collection date for primary outcome measure)

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

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

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00003561
CDR0000066625
P30CA006973 ( U.S. NIH Grant/Contract )
JHOC-98011606
JHOC-9806
NCI-V98-1468
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Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Richard J. Jones, MD Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP