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

NCT00072579 | Completed Phase 2

• 4 other identifiers: CCCWFU-23102CDR0000340983BRLX-02153NCI-7350
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 15

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.

Conditions

Leukemia

Keywords

chronic phase chronic myelogenous leukemia; chronic myelogenous leukemia, BCR-ABL1 positive

Outcome Measures

Primary Outcomes (1)

• Cytogenetic response (complete and partial)

Secondary Outcomes (3)

• Toxicity as assessed by the Expanded Common Toxicity Criteria v2.0

• Time to progression

• Survival

Interventions

sargramostim BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (15)

CCOP - Western Regional, Arizona

Phoenix, Arizona, 85006-2726, United States

Location

CCOP - Bay Area Tumor Institute

Oakland, California, 94609-3305, United States

Location

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Regional Radiation Oncology Center at Rome

Rome, Georgia, 30165, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

Kentuckiana Cancer Institute, PLLC

Louisville, Kentucky, 40202, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Alamance Cancer Center

Burlington, North Carolina, 27216, United States

Location

Hugh Chatham Memorial Hospital

Elkin, North Carolina, 28621, United States

Location

Southeastern Medical Oncology Center

Goldsboro, North Carolina, 27534-9479, United States

Location

Brody School of Medicine at East Carolina University

Greenville, North Carolina, 27858, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1096, United States

Location

CCOP - Columbus

Columbus, Ohio, 43206, United States

Location

Cancer Centers of the Carolinas - Eastside

Greenville, South Carolina, 29615, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

MeSH Terms

Conditions

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

Interventions

sargramostim

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Istvan Molnar, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

• Bayard L. Powell, MD

  Wake Forest University Health Sciences

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2003
• First Posted: November 5, 2003
• Study Start: May 1, 2003
• Primary Completion: April 1, 2006
• Study Completion: December 1, 2007
• Last Updated: January 19, 2017

Record last verified: 2013-06

Locations

US (15)