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

January 17, 2017 updated by: Wake Forest University Health Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Cytogenetic response (complete and partial)

Secondary Outcome Measures

Outcome Measure
Time to progression
Toxicity as assessed by the Expanded Common Toxicity Criteria v2.0
Survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

  • Bayard L. Powell, MD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

November 4, 2003

First Submitted That Met QC Criteria

November 4, 2003

First Posted (Estimate)

November 5, 2003

Study Record Updates

Last Update Posted (Estimate)

January 19, 2017

Last Update Submitted That Met QC Criteria

January 17, 2017

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCCWFU-23102
  • CDR0000340983 (Registry Identifier: PDQ (Physician Data Query))
  • BRLX-02153
  • NCI-7350

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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