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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00081133 |
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Combining arsenic trioxide with imatinib mesylate may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of arsenic trioxide when given with imatinib mesylate and to see how well they work in treating patients with accelerated phase or blastic phase chronic myelogenous leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia.
Condition | Intervention | Phase |
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Leukemia |
Drug: arsenic trioxide Drug: imatinib mesylate |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/II Study to Determine Safety and Efficacy of Arsenic Trioxide (Trisneox™) in Combination With Imatinib (STI571, Gleevec™) in Patients With Chronic Myelogenous Leukemia in Accelerated or Blastic Phase Disease or Ph+ Acute Lymphoblastic Leukemia |
Study Start Date: | December 2003 |
OBJECTIVES:
Primary
OUTLINE: This is a phase I dose-escalation study of arsenic trioxide followed by a phase II study.
Phase I:
Patients undergo bone marrow evaluation on week 5. Patients achieving a morphologic remission proceed to consolidation therapy. Patients not achieving morphologic remission receive a second course of imatinib mesylate as above on weeks 6-10 and arsenic trioxide as above on weeks 6-9. Patients are re-evaluated on week 10. Patients achieving morphologic remission proceed to consolidation therapy. Patients not achieving a morphologic remission are removed from study.
NOTE: *For patients who receive a second course of induction therapy
Cohorts of 6 patients receive escalating doses of arsenic trioxide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Treatment in both phases continues in the absence of unacceptable toxicity or disease progression.
After completion of consolidation therapy, patients may continue imatinib mesylate off study at the discretion of the physician. Patients who become candidates for stem cell transplantation at any time during the study are removed from study.
PROJECTED ACCRUAL: A total of 6-43 patients (6-12 for phase I and 37 [including 6 patients from phase I] for phase II) will be accrued for this study within 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of one of the following:
Chronic myelogenous leukemia (CML) in one of the following phases:
Accelerated phase*
Acute lymphoblastic leukemia
Philadelphia chromosome positive by cytogenetic confirmation
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent warfarin for therapeutic anticoagulation
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Principal Investigator: | Ellin Berman, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000358923, MSKCC-03126 |
Study First Received: | April 7, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00081133 History of Changes |
Health Authority: | United States: Federal Government |
accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia recurrent adult acute lymphoblastic leukemia untreated adult acute lymphoblastic leukemia |
Philadelphia Chromosome Blast Crisis Leukemia, Lymphoid Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Myeloproliferative Disorders Arsenic trioxide Leukemia, Myeloid Protein Kinase Inhibitors Recurrence |
Imatinib Lymphatic Diseases Leukemia Leukemia, Myeloid, Accelerated Phase Chromosome Aberrations Leukemia, Myelogenous, Chronic, BCR-ABL Positive Chronic Myelogenous Leukemia Lymphoproliferative Disorders Bone Marrow Diseases Lymphoma Acute Lymphoblastic Leukemia |
Philadelphia Chromosome Blast Crisis Leukemia, Lymphoid Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Protein Kinase Inhibitors Leukemia Neoplastic Processes Pathologic Processes Therapeutic Uses Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Immune System Diseases Hematologic Diseases |
Myeloproliferative Disorders Arsenic trioxide Enzyme Inhibitors Leukemia, Myeloid Pharmacologic Actions Translocation, Genetic Imatinib Lymphatic Diseases Neoplasms Leukemia, Myelogenous, Chronic, BCR-ABL Positive Chromosome Aberrations Bone Marrow Diseases Lymphoproliferative Disorders Cell Transformation, Neoplastic |