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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: | NCT00045006 |
RATIONALE: Suberoylanilide hydroxamic acid may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase I trial to study the effectiveness of suberoylanilide hydroxamic acid in treating patients who have advanced cancer.
Condition | Intervention | Phase |
---|---|---|
Cancer |
Drug: vorinostat |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Clinical Trial of Oral Suberoylanilide Hydroxamic Acid - SAHA (MSK390) in Patients With Advanced Solid Tumors and Hematologic Malignancies |
Study Start Date: | July 2001 |
Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation study. Patients are stratified according to disease (solid tumor vs multiple myeloma or lymphoma vs leukemia or myelodysplastic syndromes).
The initial 15-20 patients (in the solid tumor or multiple myeloma or lymphoma stratum) receive suberoylanilide hydroxamic acid (SAHA) IV over 2 hours on day 1 of week 0 and then orally once or twice daily beginning on day 1 of week 1. All remaining patients receive oral SAHA once or twice daily beginning on day 1 of week 1. Courses repeat every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
In each stratum, cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed monthly for resolution of adverse events.
PROJECTED ACCRUAL: A maximum of 114 patients (42 with solid tumors, 36 with lymphoma or multiple myeloma, and 36 with leukemia or myelodysplastic syndromes) will be accrued for this study within 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
One of the following diagnoses:
Histologically confirmed advanced primary or metastatic solid tumor, including, but not limited to, the following:
Diagnosis of lymphoma, multiple myeloma, leukemia, or myelodysplastic syndromes (MDS), including, but not limited to, the following:
For patients with solid tumors (except prostate cancer):
For prostate cancer patients only:
Biochemical progression (at least 25% increase over range of values) defined as 1 of the following:
PSA at least 4 ng/mL
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | William K. Kelly, DO | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000256306, MSKCC-01021, ATON-0101, NCI-G02-2099 |
Study First Received: | September 6, 2002 |
Last Updated: | November 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00045006 |
Health Authority: | United States: Federal Government |
acute undifferentiated leukemia de novo myelodysplastic syndromes borderline ovarian surface epithelial-stromal tumor ovarian sarcoma ovarian stromal cancer previously treated myelodysplastic syndromes prolymphocytic leukemia recurrent adult Hodgkin lymphoma recurrent adult T-cell leukemia/lymphoma recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia recurrent adult diffuse large cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent bladder cancer |
recurrent breast cancer recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent metastatic squamous neck cancer with occult primary recurrent mycosis fungoides/Sezary syndrome recurrent non-small cell lung cancer recurrent ovarian epithelial cancer recurrent ovarian germ cell tumor recurrent prostate cancer recurrent renal cell cancer refractory chronic lymphocytic leukemia refractory hairy cell leukemia refractory multiple myeloma |
Sezary syndrome Chronic myelogenous leukemia Hodgkin lymphoma, adult Malignant mesenchymal tumor Lymphoma, small cleaved-cell, diffuse Ovarian epithelial cancer Mycoses Preleukemia Leukemia, Prolymphocytic Multiple myeloma Carcinoma, Adenoid Cystic Leukemia, Lymphocytic, Chronic, B-Cell Lung Neoplasms Metastatic squamous neck cancer with occult primary Neoplasm Metastasis |
Laryngeal carcinoma Acute myeloid leukemia, adult Hodgkin Disease Salivary Gland Diseases Chronic lymphocytic leukemia Myelodysplastic syndromes Non-small cell lung cancer Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Leukemia, B-cell, chronic Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Acute myelogenous leukemia Urinary Bladder Neoplasms Myeloproliferative Disorders |
Anticarcinogenic Agents Anti-Inflammatory Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Protective Agents Pharmacologic Actions |
Neoplasms Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |