This trial is active, not recruiting.

Condition leukemia
Treatments gm-k562 cell vaccine, imatinib mesylate
Phase phase 1
Sponsor Dana-Farber Cancer Institute
Collaborator National Cancer Institute (NCI)
Start date September 2005
End date May 2007
Trial size 30 participants
Trial identifier NCT00301093, 04-126, CDR0000456445, NCT00215475, P30CA006516, R21CA115043


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Safety and Toxicity
time frame: 3 years

Secondary Outcomes

Disease Response
time frame: 3 years
Tumor immunity
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Vaccination for CML Patients With Persistent Disease on Imatinib Mesylate
Principal investigator Martha Wadleigh, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.