Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00049192 |
RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Oblimersen may help imatinib mesylate kill more cancer cells by making cancer cells more sensitive to the drug.
PURPOSE: Phase II trial to study the effectiveness of combining oblimersen with imatinib mesylate in treating patients who have chronic myelogenous leukemia that has not responded to previous treatment with imatinib mesylate.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Biological: oblimersen sodium Drug: imatinib mesylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of G3139 (Genasense, NSC #683428 IND #58842) + Imatinib Mesylate (Gleevec, STI571) in Patients With Imatinib-Resistant Chronic Myeloid Leukemia |
Study Start Date: | November 2002 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oblimersen IV continuously on days 1-10 and oral imatinib mesylate once or twice daily. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients without a hematologic response after 2 courses go off study. Patients with complete or partial response after 4 courses may continue to receive oral imatinib mesylate daily.
Patients in cohort 2 receive an escalated dose of oblimersen; if well tolerated, subsequent cohorts receive oblimersen at the higher dose with the original dose of imatinib mesylate. If oblimersen is not well tolerated in cohort 2, subsequent cohorts receive the original dose of oblimersen with an escalated dose of imatinib mesylate. The first 6 patients accrued continue to receive the original dose (dose taken prior to study) of imatinib mesylate throughout the study.
Patients are followed monthly for 3 months and then every 3 months for 5 years.
PROJECTED ACCRUAL: A total of 12-43 patients will be accrued for this study within 6 months.
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Refractory to prior imatinib mesylate by the following criteria:
If Philadelphia chromosome t(9;22) or a variant translocation is not detectable, then patients must meet 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Meir Wetzler, MD | Roswell Park Cancer Institute |
Study ID Numbers: | CDR0000257816, CALGB-10107 |
Study First Received: | November 12, 2002 |
Last Updated: | April 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00049192 History of Changes |
Health Authority: | United States: Federal Government |
Philadelphia chromosome positive chronic myelogenous leukemia chronic phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia |
Imatinib Philadelphia Chromosome Leukemia Hematologic Diseases Myeloproliferative Disorders Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
Chronic Myelogenous Leukemia Leukemia, Myeloid, Chronic-Phase Leukemia, Myeloid Bone Marrow Diseases Protein Kinase Inhibitors |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hematologic Diseases Myeloproliferative Disorders Enzyme Inhibitors Leukemia, Myeloid Protein Kinase Inhibitors |
Pharmacologic Actions Imatinib Leukemia Neoplasms Therapeutic Uses Leukemia, Myelogenous, Chronic, BCR-ABL Positive Bone Marrow Diseases |