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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: | Masking: Open Label Primary Purpose: Treatment |
| 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: | Amit M. Oza, Princess Margaret Hospital |
| ClinicalTrials.gov Identifier: | NCT00121225 History of Changes |
| Other Study ID Numbers: | CDR0000436851, PMH-PHL-040, NCI-6916 |
| Study First Received: | July 19, 2005 |
| Last Updated: | April 14, 2009 |
| 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 |
|
Melanoma Uveal Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Eye Neoplasms |
Neoplasms by Site Eye Diseases Uveal Diseases Vorinostat Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |