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

• Status: Completed
• Trial end date: 2020-09-10
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; National Cancer Institute (NCI)
• Treatments: Imatinib Mesylate; Vaccines

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:

• See Disease Characteristics

• No prior allogeneic stem cell transplantation

• At least 2 months since other prior experimental therapy

• At least 6 months since prior participation in another vaccine study

• No concurrent systemic immunosuppressive medication