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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004263 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. UCN-01 may make cancer cells more sensitive to cytarabine.
PURPOSE: Phase I trial to study the effectiveness of cytarabine and UCN-01 in treating patients who have refractory or relapsed acute myelogenous leukemia or myelodysplastic syndrome.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Myelodysplastic Syndromes |
Drug: 7-hydroxystaurosporine Drug: cytarabine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I Study of UCN-01 and Cytarabine (ARA-C) in Patients With Acute Myelogenous Leukemia, and Myelodysplastic Syndromes |
| Study Start Date: | December 1999 |
OBJECTIVES: I. Determine the maximum tolerated dose of cytarabine when combined with UCN-01 in patients with refractory or relapsed acute myelogenous leukemia or myelodysplastic syndrome. II. Determine the dose limiting toxicity, pharmacokinetics, and pharmacodynamics of this regimen in these patients.
III. Assess the antileukemia effect of this regimen in this patient population.
OUTLINE: This is a dose escalation, multicenter study of cytarabine. Patients receive cytarabine IV over 24 hours on days 1-4 of each course. Patients receive UCN-01 IV over 24 hours on days 2-4 of course 1 and over 36 hours beginning on day 2 of subsequent courses. Treatment repeats every 4 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of cytarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven refractory or relapsed acute myelogenous leukemia or myelodysplastic syndrome (refractory anemia with excess blasts (RAEB) or RAEB in transformation) Relapse or failure to respond after high dose cytarabine (greater than 1 g/m2/day for 3 days) based chemotherapy Ineligible for allogeneic bone marrow transplantation
PATIENT CHARACTERISTICS: Age: Not specified Performance status: 0-2 Life expectancy: Not specified Hematopoietic: Peripheral blood circulating blasts at least 2,000/mm3 Hepatic: Bilirubin normal Renal: Creatinine normal OR Creatinine clearance normal Other: Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 24 hours since prior hydroxyurea for rapidly proliferative disease At least 2 weeks since other prior chemotherapy (unless there is evidence of rapidly progressive disease) and recovered Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Contacts and Locations| United States, Ohio | |
| Arthur G. James Cancer Hospital - Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Study Chair: | Jorge Cortes, MD | M.D. Anderson Cancer Center |
More Information
| Study ID Numbers: | CDR0000067522, MDA-DM-99165, NCI-T99-0100 |
| Study First Received: | January 28, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00004263 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent adult acute myeloid leukemia refractory anemia with excess blasts refractory anemia with excess blasts in transformation previously treated myelodysplastic syndromes childhood myelodysplastic syndromes |
|
Antimetabolites Immunologic Factors Precancerous Conditions Hematologic Diseases Myelodysplastic Syndromes Anemia 7-hydroxystaurosporine Leukemia, Myeloid Leukemia, Myeloid, Acute Protein Kinase Inhibitors Immunosuppressive Agents Antiviral Agents |
Recurrence Refractory Anemia Leukemia Preleukemia Acute Myelocytic Leukemia Anemia, Refractory Acute Myeloid Leukemia, Adult Staurosporine Anemia, Refractory, with Excess of Blasts Bone Marrow Diseases Cytarabine |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Precancerous Conditions Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Leukemia, Myeloid, Acute Protein Kinase Inhibitors Leukemia Preleukemia Pathologic Processes Syndrome Therapeutic Uses |
Staurosporine Cytarabine Disease Neoplasms by Histologic Type Hematologic Diseases Myelodysplastic Syndromes Enzyme Inhibitors Leukemia, Myeloid 7-hydroxystaurosporine Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Bone Marrow Diseases |
