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

Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00072579
• Other study ID #: CCCWFU-23102
• Secondary ID: CDR0000340983BRL
• Status: Completed
• Phase: Phase 2
• First received: November 4, 2003
• Last updated: January 17, 2017
• Start date: May 2003
• Est. completion date: December 2007

Study information

• Verified date: June 2013
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2007
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Chronic-Phase

Intervention

Biological:
• sargramostim

Locations

Country	Name	City	State
United States	Alamance Cancer Center	Burlington	North Carolina
United States	CCOP - Columbus	Columbus	Ohio
United States	CCOP - Central Illinois	Decatur	Illinois
United States	Hugh Chatham Memorial Hospital	Elkin	North Carolina
United States	Southeastern Medical Oncology Center	Goldsboro	North Carolina
United States	Brody School of Medicine at East Carolina University	Greenville	North Carolina
United States	Cancer Centers of the Carolinas - Eastside	Greenville	South Carolina
United States	Kentuckiana Cancer Institute, PLLC	Louisville	Kentucky
United States	CCOP - Mount Sinai Medical Center	Miami Beach	Florida
United States	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana
United States	CCOP - Bay Area Tumor Institute	Oakland	California
United States	CCOP - Western Regional, Arizona	Phoenix	Arizona
United States	Regional Radiation Oncology Center at Rome	Rome	Georgia
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cytogenetic response (complete and partial)
Secondary	Toxicity as assessed by the Expanded Common Toxicity Criteria v2.0
Secondary	Time to progression
Secondary	Survival