Vaccination for CML Patients With Persistent Disease on Imatinib Mesylate
- 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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and Toxicity
To assess the safety and toxicity of GM-K462 vaccination in CP CML patients who have acheived a complete hematologic response to imatinib.
Martha Wadleigh, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana Farber Cancer Institute||Boston, Massachusetts 02115|