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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00015860 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. STI571 may stop the growth of leukemia cells. Combining chemotherapy and STI571 may kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus STI571 in treating patients who have chronic myelogenous leukemia or acute lymphocytic leukemia.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Drug: daunorubicin hydrochloride Drug: imatinib mesylate Drug: prednisone Drug: vincristine sulfate |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/II Trial of STI-571 and Chemotherapy in Lymphoid Blast Crisis of Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Lymphoid Leukemia |
Study Start Date: | May 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of daunorubicin.
Patients who have not previously received imatinib mesylate receive oral imatinib mesylate on days 1-35. Patients who have previously received imatinib mesylate for at least 28 days receive oral imatinib mesylate on days 22-35. All patients receive daunorubicin IV over 2-3 minutes on days 1-3, vincristine IV over 1 minute on days 1, 8, 15, and 22, and oral prednisone on days 1-28. Patients with more than 5% residual blasts in bone marrow on day 28 receive a second course in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of daunorubicin 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. Once the MTD is determined, additional patients are treated at the recommended phase II dose.
PROJECTED ACCRUAL: A maximum of 46 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:
One of the following diagnoses:
Acute lymphoblastic leukemia (ALL) that is in first relapse or failed induction
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, California | |
City of Hope Comprehensive Cancer Center | |
Duarte, California, United States, 91010 | |
Jonsson Comprehensive Cancer Center, UCLA | |
Los Angeles, California, United States, 90095 | |
Stanford University Medical Center | |
Stanford, California, United States, 94305-5408 | |
United States, Oregon | |
Oregon Cancer Institute | |
Portland, Oregon, United States, 97239 | |
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 |
Principal Investigator: | Ronald Paquette, MD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000068444, UCLA-0011010, UCLA-NCI-4292, NCI-4292 |
Study First Received: | May 6, 2001 |
Last Updated: | August 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00015860 |
Health Authority: | United States: Federal Government |
recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia blastic phase chronic myelogenous leukemia |
Philadelphia Chromosome Prednisone Daunorubicin Blast Crisis Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Chronic myelogenous leukemia Hematologic Diseases Myeloproliferative Disorders Vincristine |
Leukemia, Myeloid Recurrence Acute lymphoblastic leukemia, adult Imatinib Leukemia Lymphatic Diseases Leukemia, Myelogenous, Chronic, BCR-ABL Positive Bone Marrow Diseases Lymphoproliferative Disorders Lymphoma |
Anti-Inflammatory Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors |
Antimitotic Agents Antibiotics, Antineoplastic Protein Kinase Inhibitors Glucocorticoids Hormones Pharmacologic Actions Neoplasms Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |