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

This study has been terminated.
Sponsor:
Collaborator:
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00003561
First received: November 1, 1999
Last updated: July 19, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
Leukemia
Biological: recombinant interferon alfa
Biological: sargramostim
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Granulocyte-Macrophage Colony Stimulating Factor (Rhu-GM-CSF) With Interferon-Alpha (IFN-alpha) for Chronic Myeloid Leukemia

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Estimated Enrollment: 48
Study Start Date: February 1998
Study Completion Date: August 2010
Primary Completion Date: October 2001 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003561

Locations
United States, Maryland
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Study Chair: Richard J. Jones, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00003561     History of Changes
Other Study ID Numbers: CDR0000066625, P30CA006973, JHOC-98011606, JHOC-9806, NCI-V98-1468
Study First Received: November 1, 1999
Last Updated: July 19, 2011
Health Authority: United States: Federal Government

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
chronic phase chronic myelogenous leukemia
Philadelphia chromosome positive chronic myelogenous leukemia
Philadelphia chromosome negative chronic myelogenous leukemia

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia
Leukemia, Myeloid, Chronic-Phase
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Interferons
Interferon-alpha
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014