Sargramostim in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Are Not in Complete Cytogenetic Remission Following Initial Treatment - Full Text View

Sponsors and Collaborators:	Wake Forest University National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00072579

Purpose

RATIONALE: Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood and may bring about complete remission in patients who have chronic phase chronic myelogenous leukemia.

PURPOSE: This phase II trial is studying sargramostim to see how well it works in treating patients with chronic phase chronic myelogenous leukemia that is not in complete cytogenetic remission after initial treatment.

Condition	Intervention	Phase
Leukemia	Biological: sargramostim	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase II Study of GM-CSF in Patients With Chronic Phase Chronic Myeloid Leukemia (CP-CML) Who Are Not in Complete Cytogenetic Remission After Initial Therapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Granulocyte-macrophage colony-stimulating factor Sargramostim

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Cytogenetic response (complete and partial) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity as assessed by the Expanded Common Toxicity Criteria v2.0 [ Designated as safety issue: Yes ]
Time to progression [ Designated as safety issue: No ]
Survival [ Designated as safety issue: No ]

Study Start Date:

September 2003

Detailed Description:

OBJECTIVES:

Determine the efficacy and safety of sargramostim (GM-CSF) by cytogenetic examination of the bone marrow in patients with chronic phase chronic myelogenous leukemia who are not in complete cytogenetic remission after initial therapy.

OUTLINE: Patients receive sargramostim (GM-CSF) subcutaneously daily for 3 months in the absence of disease progression or unacceptable toxicity.

Patients achieving no response receive GM-CSF for an additional 3 months. Patients failing to achieve a partial response or better after the second course of GM-CSF are removed from the study. Patients achieving a partial response after the first or second course of GM-CSF continue to receive GM-CSF for an additional 9 months. Patients are then re-evaluated. Patients achieving a complete cytologic response at 9 months then receive GM-CSF 3 times weekly in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 weeks.

PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study within 3 years.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed chronic phase chronic myelogenous leukemia (CML)
- Presence of t(9;22)(q34;q11) with at least 20 cells examined in metaphase by cytogenetic examination of the bone marrow
Complete hematologic remission during prior therapy* as seen on 2 separate blood count analyses, defined by the following:
- WBC no greater than 10,000/mm^3 AND platelet count no greater than 450,000/mm^3
- Disappearance of all signs and symptoms of disease, including palpable splenomegaly
- Normal differential counts (i.e., absence of blasts, promyelocytes, myelocytes, and metamyelocytes) NOTE: *Continuation of therapy that led to complete hematologic remission is required during study participation
Persistent cytogenetic disease despite 12 months of prior imatinib mesylate therapy, which may have included a trial dose-escalation OR intolerant of imatinib mesylate at a dose greater than 400 mg/day
Not in complete cytogenetic remission within 30 days of study entry
- Persistent Philadelphia chromosome by bone marrow exam

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

More than 6 months

Hematopoietic

See Disease Characteristics

Hepatic

Not specified

Renal

Not specified

Other

Not pregnant or nursing
Fertile patients must use effective contraception
No uncontrolled active infective
No serious medical or psychiatric illness that would prevent giving informed consent or limit survival to less than 6 months
No other malignancy not in remission except curatively treated basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

Prior sargramostim (GM-CSF) allowed
Prior interferon alfa for CML allowed
No prior stem cell transplantation
Concurrent interferon alfa* for CML allowed NOTE: *No dose increase during study participation

Chemotherapy

At least 4 weeks since prior chemotherapy

Endocrine therapy

Not specified

Radiotherapy

At least 4 weeks since prior radiotherapy
No concurrent radiotherapy

Surgery

At least 4 weeks since prior surgery

Other

Prior imatinib mesylate for CML allowed
No other concurrent medication for CML
Concurrent imatinib mesylate* for CML allowed NOTE: *No dose increase during study participation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00072579

Locations

United States, Arizona
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States, 85006-2726
United States, California
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
United States, Florida
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
United States, Georgia
Regional Radiation Oncology Center at Rome
Rome, Georgia, United States, 30165
United States, Illinois
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
United States, Kentucky
Kentuckiana Cancer Institute, PLLC
Louisville, Kentucky, United States, 40202
United States, Louisiana
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, North Carolina
Alamance Cancer Center
Burlington, North Carolina, United States, 27216
Brody School of Medicine at East Carolina University
Greenville, North Carolina, United States, 27858
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1096
Hugh Chatham Memorial Hospital
Elkin, North Carolina, United States, 28621
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States, 27534-9479
United States, Ohio
CCOP - Columbus
Columbus, Ohio, United States, 43206
United States, South Carolina
Cancer Centers of the Carolinas - Eastside
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303

Sponsors and Collaborators

Wake Forest University

National Cancer Institute (NCI)

Investigators

Study Chair:	Istvan Molnar, MD	Wake Forest University
Investigator:	Bayard L. Powell, MD	Wake Forest University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000340983, CCCWFU-23102, BRLX-02153, NCI-7350
Study First Received:	November 4, 2003
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00072579 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

chronic phase chronic myelogenous leukemia
Philadelphia chromosome positive chronic myelogenous leukemia

Study placed in the following topic categories:

Philadelphia Chromosome
Leukemia
Hematologic Diseases
Myeloproliferative Disorders
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Chronic Myelogenous Leukemia
Leukemia, Myeloid, Chronic-Phase
Leukemia, Myeloid
Bone Marrow Diseases

Additional relevant MeSH terms:

Leukemia
Neoplasms
Neoplasms by Histologic Type
Hematologic Diseases
Myeloproliferative Disorders

Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Leukemia, Myeloid
Bone Marrow Diseases

ClinicalTrials.gov processed this record on July 02, 2009