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Sponsors and Collaborators: |
Dana-Farber Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00301093 |
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 | Intervention | Phase |
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Leukemia |
Drug: GM-K562 cell vaccine Drug: imatinib mesylate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Vaccination for CML Patients With Persistent Disease on Imatinib Mesylate |
Estimated Enrollment: | 30 |
Study Start Date: | September 2005 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of chronic myelogenous leukemia
Disease in first complete hematologic response, defined by all of the following:
Persistent molecular evidence of disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 |
Study Chair: | Catherine J. Wu, MD | Dana-Farber Cancer Institute |
Study ID Numbers: | CDR0000456445, DFCI-04126 |
Study First Received: | March 8, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00301093 |
Health Authority: | United States: Federal Government |
chronic phase chronic myelogenous leukemia Philadelphia chromosome positive chronic myelogenous leukemia |
Imatinib Philadelphia Chromosome Leukemia Chronic myelogenous leukemia Hematologic Diseases |
Myeloproliferative Disorders Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase Leukemia, Myeloid Bone Marrow Diseases |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |