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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00305773 |
RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for their growth. Giving the drug in different ways may kill more cancer cells.
PURPOSE: This randomized phase II trial is studying two different schedules of vorinostat to see how well they work in treating patients with acute myeloid leukemia.
Condition | Intervention | Phase |
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Leukemia Myelodysplastic Syndromes |
Drug: vorinostat |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A Phase II Study of Suberoylanilide Hydroxamic Acid (SAHA) in Acute Myeloid Leukemia (AML) |
Estimated Enrollment: | 44 |
Study Start Date: | January 2006 |
Estimated Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive oral vorinostat (SAHA) once a day on days 1-21.
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Drug: vorinostat
Given orally
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Arm II: Experimental
Patients receive oral SAHA three times a day on days 1-14.
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Drug: vorinostat
Given orally
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, randomized study.
Patients are stratified according to disease status (relapsed vs untreated). Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed periodically for up to 2 years.
PROJECTED ACCRUAL: A total of 44 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 acute myeloid leukemia (AML), meeting 1 of the following criteria:
Relapsed AML in the following categories:
Untreated AML in the following categories:
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness, including any of the following:
PRIOR CONCURRENT THERAPY:
More than 3 weeks since other prior treatment for AML, including hematopoietic growth factors
United States, Arizona | |
Mayo Clinic Scottsdale | |
Scottsdale, Arizona, United States, 85259-5499 | |
United States, Florida | |
Mayo Clinic - Jacksonville | |
Jacksonville, Florida, United States, 32224 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231-2410 | |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201-1379 | |
United States, Missouri | |
Siteman Cancer Center at Barnes-Jewish Hospital | |
Saint Louis, Missouri, United States, 63110 | |
United States, Wisconsin | |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792-6164 |
Study Chair: | Steven D. Gore, MD | Sidney Kimmel Comprehensive Cancer Center |
Responsible Party: | Mayo Clinic Cancer Center ( Charles Erlichman ) |
Study ID Numbers: | CDR0000465213, MAYO-MC0483, JHOC-J0557, JHOC-J0550, NCI-6882 |
Study First Received: | March 21, 2006 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00305773 History of Changes |
Health Authority: | United States: Food and Drug Administration |
recurrent adult acute myeloid leukemia untreated adult acute myeloid leukemia adult acute erythroid leukemia (M6) adult acute megakaryoblastic leukemia (M7) adult acute monoblastic leukemia (M5a) adult acute monocytic leukemia (M5b) adult acute myeloblastic leukemia with maturation (M2) adult acute myeloblastic leukemia without maturation (M1) adult acute myeloid leukemia with 11q23 (MLL) abnormalities |
adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) adult acute myelomonocytic leukemia (M4) adult acute promyelocytic leukemia (M3) refractory cytopenia with multilineage dysplasia secondary acute myeloid leukemia adult acute minimally differentiated myeloid leukemia (M0) |
Anticarcinogenic Agents Leukemia, Monocytic, Acute Anti-Inflammatory Agents Precancerous Conditions Acute Myelomonocytic Leukemia Acute Monoblastic Leukemia Leukemia, Myeloid, Acute Leukemia Preleukemia Acute Myelocytic Leukemia Acute Erythroblastic Leukemia Acute Myeloid Leukemia, Adult Leukemia, Promyelocytic, Acute Neoplasm Metastasis Anti-Inflammatory Agents, Non-Steroidal |
Analgesics Congenital Abnormalities Hematologic Diseases Myelodysplastic Syndromes Vorinostat Leukemia, Myeloid Recurrence Leukemia, Myelomonocytic, Acute Leukemia, Erythroblastic, Acute Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Bone Marrow Diseases Acute Promyelocytic Leukemia Di Guglielmo's Syndrome |
Anticarcinogenic Agents Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Precancerous Conditions Antineoplastic Agents Physiological Effects of Drugs Leukemia, Myeloid, Acute Leukemia Preleukemia Pathologic Processes Sensory System Agents Syndrome Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics |
Disease Neoplasms by Histologic Type Hematologic Diseases Myelodysplastic Syndromes Vorinostat Enzyme Inhibitors Leukemia, Myeloid Protective Agents Pharmacologic Actions Neoplasms Analgesics, Non-Narcotic Peripheral Nervous System Agents Bone Marrow Diseases Antirheumatic Agents Central Nervous System Agents |