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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Cytogenetic response (complete and partial)

Safety Issue:

No

Principal Investigator

Istvan Molnar, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Federal Government

Study ID:

CCCWFU-23102

NCT ID:

NCT00072579

Start Date:

May 2003

Completion Date:

December 2007

Related Keywords:

  • Leukemia
  • chronic phase chronic myelogenous leukemia
  • chronic myelogenous leukemia, BCR-ABL1 positive
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid, Chronic-Phase

Name

Location

CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - ColumbusColumbus, Ohio  43206
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Regional Radiation Oncology Center at RomeRome, Georgia  30165
Alamance Cancer CenterBurlington, North Carolina  27216
Southeastern Medical Oncology CenterGoldsboro, North Carolina  27534
Cancer Centers of the Carolinas - EastsideGreenville, South Carolina  29601
Kentuckiana Cancer Institute, PLLCLouisville, Kentucky  40202
Hugh Chatham Memorial HospitalElkin, North Carolina  28621
Brody School of Medicine at East Carolina UniversityGreenville, North Carolina  27858