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

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00072579

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Leukemia	Biological: sargramostim	Phase 2

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.

Study Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

May 1, 2003

Actual Primary Completion Date :

Apr 1, 2006

Actual Study Completion Date :

Dec 1, 2007

Outcome Measures

Primary Outcome Measures

Cytogenetic response (complete and partial) []

Secondary Outcome Measures

Toxicity as assessed by the Expanded Common Toxicity Criteria v2.0 []
Time to progression []
Survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

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