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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: vorinostat Other: pharmacological study |
Phase I |
| Study Type: | Interventional |
| Study Design: | 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 |
| Estimated Primary Completion Date: | January 2012 (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).
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 | Recruiting |
| Duarte, California, United States, 91010-3000 | |
| Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org | |
| City of Hope Medical Group | Recruiting |
| South Pasadena, California, United States, 91030 | |
| Contact: Mark V. McNamara, MD 626-396-2900 mmcnamara@ccsmg.com | |
| University of California Davis Cancer Center | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Clinical Trials Office - University of California Davis Cancer 916-734-3089 | |
| USC/Norris Comprehensive Cancer Center and Hospital | Recruiting |
| Los Angeles, California, United States, 90089-9181 | |
| Contact: Clinical Trials Office - USC/Norris Comprehensive Cancer Cente 323-865-0451 | |
| United States, Georgia | |
| Winship Cancer Institute of Emory University | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Suresh Ramalingam, MD 404-778-1919 | |
| United States, Maryland | |
| NCI - Medical Oncology Branch | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: Shivaani Kummar, MD 301-435-5402 kummars@mail.nih.gov | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
| Bethesda, Maryland, United States, 20892-1182 | |
| Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | Recruiting |
| Detroit, Michigan, United States, 48201-1379 | |
| Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute 313-576-9363 | |
| United States, New York | |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | Recruiting |
| Bronx, New York, United States, 10461 | |
| Contact: Clinical Trials Office - Albert Einstein Cancer Center at Albe 718-904-2730 aecc@aecom.yu.edu | |
| 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, Pennsylvania | |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Recruiting |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| Contact: Clinical Trials Office - Penn State Cancer Institute at Milton 717-531-3779 CTO@hmc.psu.edu | |
| UPMC Cancer Centers | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Contact: Clinical Trials Office - UPMC Cancer Centers 412-647-8073 | |
| United States, Texas | |
| Institute for Drug Development | Recruiting |
| San Antonio, Texas, United States, 78245-3217 | |
| Contact: Clinical Trials Office - Institute for Drug Development 800-340-2872 | |
| United States, Wisconsin | |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Recruiting |
| Madison, Wisconsin, United States, 53792-6164 | |
| Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo 608-262-5223 | |
| Study Chair: | Suresh Ramalingam, MD | University of Pittsburgh |
| Principal Investigator: | Shivaani Kummar, MD | NCI - Medical Oncology Branch |
More Information
| Study ID Numbers: | CDR0000555102, PCI-07013, PCI-UPCI 07-013, NCI-07-C-0228 |
| Study First Received: | July 10, 2007 |
| Last Updated: | October 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00499811 History of Changes |
| Health Authority: | Unspecified |
|
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 |
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Anticarcinogenic Agents Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Physiological Effects of Drugs Ileal Diseases Duodenal Neoplasms Neoplasms by Site Ileal Neoplasms Sensory System Agents Jejunal Diseases Therapeutic Uses Lymphoma, Large-Cell, Immunoblastic Anti-Inflammatory Agents, Non-Steroidal |
Analgesics Lymphoma Duodenal Diseases Jejunal Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Digestive System Neoplasms Immune System Diseases Vorinostat Enzyme Inhibitors Intestinal Diseases Protective Agents Pharmacologic Actions Intestinal Neoplasms Lymphatic Diseases |