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Sponsors and Collaborators: |
Massey Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00278330 |
RATIONALE: Flavopiridol and vorinostat may cause leukemia cells to look more like normal cells, and to grow and spread more slowly. Vorinostat may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving flavopiridol together with vorinostat may be an effective treatment for leukemia or refractory anemia.
PURPOSE: This phase I trial is studying the side effects and best dose of flavopiridol when given together with vorinostat in treating patients with relapsed or refractory acute leukemia or chronic myelogenous leukemia or refractory anemia.
Condition | Intervention | Phase |
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Leukemia Myelodysplastic Syndromes |
Drug: alvocidib Drug: vorinostat |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Trial of Vorinostat (SAHA) in Combination With Flavopiridol in Patients With Relapsed, Refractory, or (Selected) Poor Prognosis Acute Leukemia or Refractory Anemia With Excess Blasts-2 |
Estimated Enrollment: | 24 |
Study Start Date: | January 2006 |
Estimated Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, dose-escalation study of flavopiridol.
Patients receive flavopiridol IV over 1 hour on days 1-5 and oral vorinostat three times daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of flavopiridol 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.
PROJECTED ACCRUAL: A total of 24 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 one of the following:
PATIENT CHARACTERISTICS:
WBC < 50,000µL
PRIOR CONCURRENT THERAPY:
United States, Ohio | |
Case Comprehensive Cancer Center | Recruiting |
Cleveland, Ohio, United States, 44106-5065 | |
Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422 | |
United States, Virginia | |
Virginia Commonwealth University Massey Cancer Center | Recruiting |
Richmond, Virginia, United States, 23298-0037 | |
Contact: Clinical Trials Office -Virginia Commonwealth University Masse 804-628-1939 |
Study Chair: | Steven Grant, MD | Massey Cancer Center |
Study ID Numbers: | CDR0000454998, MCV-MCC-6637, NCI-6637 |
Study First Received: | January 16, 2006 |
Last Updated: | January 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00278330 History of Changes |
Health Authority: | Unspecified |
recurrent adult acute myeloid leukemia blastic phase chronic myelogenous leukemia refractory anemia with excess blasts relapsing chronic myelogenous leukemia |
recurrent adult acute lymphoblastic leukemia untreated adult acute lymphoblastic leukemia untreated adult acute myeloid leukemia |
Anticarcinogenic Agents Anti-Inflammatory Agents Blast Crisis Leukemia, Lymphoid Precancerous Conditions Leukemia, Myeloid, Acute Protein Kinase Inhibitors Refractory Anemia Leukemia Preleukemia Acute Myelocytic Leukemia Anemia, Refractory Acute Myeloid Leukemia, Adult Anti-Inflammatory Agents, Non-Steroidal Analgesics |
Acute Lymphoblastic Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Myelodysplastic Syndromes Vorinostat Anemia Myeloproliferative Disorders Leukemia, Myeloid Recurrence Flavopiridol Analgesics, Non-Narcotic Leukemia, Myelogenous, Chronic, BCR-ABL Positive Peripheral Nervous System Agents Anemia, Refractory, with Excess of Blasts Chronic Myelogenous Leukemia |
Anticarcinogenic Agents Anti-Inflammatory Agents Precancerous Conditions Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Protein Kinase Inhibitors Leukemia Preleukemia Anemia, Refractory Pathologic Processes Sensory System Agents Therapeutic Uses Syndrome Anti-Inflammatory Agents, Non-Steroidal |
Analgesics Growth Inhibitors Neoplasms by Histologic Type Disease Hematologic Diseases Growth Substances Myelodysplastic Syndromes Vorinostat Anemia Myeloproliferative Disorders Enzyme Inhibitors Leukemia, Myeloid Protective Agents Pharmacologic Actions Flavopiridol |