Vaccine Therapy and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia
NCT ID: NCT00301093
Last Updated: 2020-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
3 participants
INTERVENTIONAL
2005-09-30
2020-09-10
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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GM-K562 cell vaccine
Once weekly for 3 vaccination, then every other week for 3 vaccinations, and then every month for 3 vaccinations until the participant has received a total of 9 vaccinations
imatinib mesylate
Participants will continue on current dose
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Beth Israel Deaconess Medical Center
OTHER
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Martha Wadleigh, M.D.
Principal Investigator
Principal Investigators
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Martha Wadleigh, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Dana Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Other Identifiers
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CDR0000456445
Identifier Type: REGISTRY
Identifier Source: secondary_id
04-126
Identifier Type: -
Identifier Source: org_study_id
NCT00215475
Identifier Type: -
Identifier Source: nct_alias