Vaccine Therapy and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia
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|ClinicalTrials.gov Identifier: NCT00301093|
Recruitment Status : Active, not recruiting
First Posted : March 10, 2006
Last Update Posted : February 1, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Biological: GM-K562 cell vaccine Drug: imatinib mesylate||Phase 1|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vaccination for CML Patients With Persistent Disease on Imatinib Mesylate|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||May 2007|
|Estimated Study Completion Date :||January 1, 2019|
- Biological: 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
- Drug: imatinib mesylate
Participants will continue on current dose
- Safety and Toxicity [ Time Frame: 3 years ]To assess the safety and toxicity of GM-K462 vaccination in CP CML patients who have acheived a complete hematologic response to imatinib.
- Disease Response [ Time Frame: 3 years ]To assess disease response after GM-K562 vaccination by serial BCR-ABL Q-PCR measurements
- Tumor immunity [ Time Frame: 3 years ]To characterize the development of tumor immunity in response to vaccination with GM-K562 cells
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00301093
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Martha Wadleigh, MD||Dana-Farber Cancer Institute|