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| Sponsor: | University of Pittsburgh |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00499811 |
Purpose
RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Vorinostat may have different effects in patients who have changes in their liver function.
PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat in treating patients with metastatic or unresectable solid tumors or lymphoma and liver dysfunction. (closed for accrual as of 04/05/2010)
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Lymphoma Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: vorinostat Other: pharmacological study |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I and Pharmacokinetic Study of Vorinostat for Solid Tumors and Lymphomas in Patients With Varying Degrees of Hepatic Dysfunction |
| Estimated Enrollment: | 118 |
| Study Start Date: | June 2007 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a parallel-group, dose-escalation study. Patients are stratified according to level of hepatic dysfunction (normal vs mild vs moderate vs severe).(closed for accrual as of 04/05/2010)
Blood samples are obtained periodically on day -6 for pharmacokinetic studies.
Dose escalation will proceed within each hepatic dysfunction group (except in the normal group). Only dose-limiting toxicities (DLTs) that occur during the first cycle of treatment will be used to guide dose escalation. The maximum tolerated dose (MTD) is the highest dose at which no more than one instance of DLT is observed (among 6 patients treated). Once the MTD has been determined for a given hepatic dysfunction group, a maximum of 12 patients will be accrued to this dose level.
After completion of study treatment, patients are followed for 4 weeks.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed solid malignancy or lymphoma that is metastatic or unresectable
Standard curative or palliative measures do not exist or are no longer effective
Patients with abnormal liver function will be eligible
Patients with biliary obstruction for which a shunt has been placed are eligible, provided the shunt has been in place for at least 10 days prior to the first dose of vorinostat (SAHA) and liver function has stabilized
Patients with gliomas or brain metastases who require corticosteroids or anticonvulsants must be on a stable dose of corticosteroids and seizure free for 1 month prior to study enrollment
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
More than 3 weeks since prior chemotherapy or radiotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
Contacts and Locations| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90089-9181 | |
| City of Hope Medical Group | |
| Pasadena, California, United States, 91105 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| United States, Georgia | |
| Winship Cancer Institute of Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Maryland | |
| NCI - Medical Oncology Branch | |
| Bethesda, Maryland, United States, 20892 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| United States, New York | |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | |
| Bronx, New York, United States, 10461 | |
| United States, Ohio | |
| Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| United States, Pennsylvania | |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| UPMC Cancer Centers | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, Texas | |
| Institute for Drug Development | |
| San Antonio, Texas, United States, 78245-3217 | |
| United States, Wisconsin | |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-6164 | |
| Study Chair: | Suresh Ramalingam, MD | University of Pittsburgh |
| Principal Investigator: | Shivaani Kummar, MD | NCI - Medical Oncology Branch |
More Information
| ClinicalTrials.gov Identifier: | NCT00499811 History of Changes |
| Other Study ID Numbers: | CDR0000555102, PCI-07013, PCI-UPCI 07-013, NCI-07-C-0228 |
| Study First Received: | July 10, 2007 |
| Last Updated: | February 19, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
unspecified adult solid tumor, protocol specific recurrent adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma stage III adult Hodgkin lymphoma recurrent adult T-cell leukemia/lymphoma stage IV adult T-cell leukemia/lymphoma stage III adult T-cell leukemia/lymphoma anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma cutaneous B-cell non-Hodgkin lymphoma recurrent mycosis fungoides/Sezary syndrome stage IV mycosis fungoides/Sezary syndrome stage III mycosis fungoides/Sezary syndrome recurrent cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma |
stage III cutaneous T-cell non-Hodgkin lymphoma stage IV adult Burkitt lymphoma stage III adult Burkitt lymphoma stage IV adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse mixed cell lymphoma stage III adult diffuse mixed cell lymphoma stage IV adult diffuse small cleaved cell lymphoma stage III adult diffuse small cleaved cell lymphoma stage IV adult immunoblastic large cell lymphoma stage III adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage III adult lymphoblastic lymphoma stage IV grade 1 follicular lymphoma stage III grade 1 follicular lymphoma |
|
Lymphoma Lymphoma, Non-Hodgkin Nervous System Neoplasms Lymphoma, Large-Cell, Immunoblastic Central Nervous System Neoplasms Liver Diseases Duodenal Neoplasms Ileal Neoplasms Jejunal Neoplasms Neoplasms Intestinal Neoplasms Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Neoplasms by Site Nervous System Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Gastrointestinal Diseases Duodenal Diseases Intestinal Diseases Ileal Diseases Jejunal Diseases Vorinostat Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |