Vaccine Therapy and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia

Dana-Farber Cancer Institute

Status and phase

Completed

Phase 1

Conditions

Leukemia

Treatments

Drug: imatinib mesylate

Biological: GM-K562 cell vaccine

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00301093

04-126

P30CA006516 (U.S. NIH Grant/Contract)

R21CA115043 (U.S. NIH Grant/Contract)

CDR0000456445 (Registry Identifier)

Details and patient eligibility

About

RATIONALE: Vaccines made from gene-modified cancer cells may help the body build an effective immune response to kill cancer cells. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving vaccine therapy together with imatinib mesylate may be an effective treatment for chronic myelogenous leukemia.

PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy when given together with imatinib mesylate in treating patients with chronic phase chronic myelogenous leukemia.

Full description

OBJECTIVES:

Primary

Determine the maximum tolerated dose of GM-K562 cell vaccine when administered with imatinib mesylate in patients with persistent chronic phase chronic myelogenous leukemia in first hematologic response.
Determine the safety and toxic effects of GM-K562 cell vaccination in these patients.

Secondary

Determine the disease response by serial BCR-ABL quantitative polymerase chain reaction measurements in patients treated with this regimen.
Determine the development of tumor immunity in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of GM-K562.

Patients continue to receive oral imatinib mesylate at the same stable dose as before study entry. Patients receive GM-K562 subcutaneously on days 1, 8, 15, 29, 43, 57, 85, 113, and 141 in the absence of disease progression or unacceptable toxicity.

Cohorts of 10 patients receive escalating doses of GM-K562 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 10 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed periodically for 20 years.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Diagnosis of chronic myelogenous leukemia
- Chronic phase disease
- Philadelphia chromosome positive disease
Disease in first complete hematologic response, defined by all of the following:
- Complete normalization of peripheral blood counts with WBC < 10,000/mm^3
- Platelet count < 450,000/mm^3
- No immature cells (e.g., myelocytes, metamyelocytes, or blasts) in the peripheral blood
Persistent molecular evidence of disease
- Detectable BCR-ABL transcript by quantitative polymerase chain reaction
- Less than 2 log reduction in peripheral blood or bone marrow BCR-ABL transcripts levels compared to a standardized baseline
Must have received imatinib mesylate for > 1 year of which the last 3 months were at stable dose ≥ 300 mg/day

PATIENT CHARACTERISTICS:

Not pregnant or nursing
Fertile patients must use effective contraception
Negative pregnancy test
No known HIV
ALT or AST ≤ 3 times upper limit of normal
Oxygen saturation ≥ 93% at room air
No history of recent acute myocardial infarction
No history of unstable angina
No pulmonary decomposition requiring hospitalization within the past 3 months
No concurrent and/or uncontrolled psychiatric or medical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY: