Status:
COMPLETED
Vaccine Therapy and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Beth Israel Deaconess Medical Center
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 so...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2020
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00301093
Start Date
September 1 2005
End Date
September 10 2020
Last Update
October 28 2020
Active Locations (1)
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1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115