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| Sponsor: | Princess Margaret Hospital, Canada |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00121225 |
Purpose
RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well vorinostat works in treating patients with metastatic or unresectable melanoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Intraocular Melanoma Melanoma (Skin) |
Drug: vorinostat |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study of Suberoylanilide Hydroxamic Acid (SAHA) in Advanced Melanoma |
| Estimated Enrollment: | 32 |
| Study Start Date: | September 2005 |
| Estimated Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral vorinostat once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 4 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study within 10-16 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed melanoma
The following melanoma types are allowed:
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Pennsylvania | |
| Abramson Cancer Center of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
| Canada, Ontario | |
| Margaret and Charles Juravinski Cancer Centre | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Principal Investigator: | Naomi S. Balzer-Haas, MD | Abramson Cancer Center of the University of Pennsylvania |
More Information
| Responsible Party: | Princess Margaret Hospital ( Amit M. Oza ) |
| Study ID Numbers: | CDR0000436851, PMH-PHL-040, NCI-6916 |
| Study First Received: | July 19, 2005 |
| Last Updated: | April 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00121225 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent melanoma stage IV melanoma recurrent intraocular melanoma metastatic intraocular melanoma |
iris melanoma extraocular extension melanoma ciliary body and choroid melanoma, medium/large size |
|
Anticarcinogenic Agents Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Melanoma Neoplasms by Site Sensory System Agents Neoplasms, Germ Cell and Embryonal Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Nevi and Melanomas Analgesics |
Neoplasms by Histologic Type Eye Neoplasms Eye Diseases Vorinostat Enzyme Inhibitors Protective Agents Pharmacologic Actions Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |