Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00112606 |
RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop tumor cells from growing. Lenalidomide may also stop the growth of eye melanoma by blocking blood flow to the tumor.
PURPOSE: This randomized phase II trial is studying two different doses of lenalidomide to see how well it works in treating patients with eye melanoma.
Condition | Intervention | Phase |
---|---|---|
Intraocular Melanoma |
Drug: lenalidomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A Phase II Randomized Study of Oral CC-5013 Lenalidomide (Revlimid), an Antiangiogenic and Immunomodulatory Agent in Subjects With Stage IV Ocular Melanoma |
Estimated Enrollment: | 38 |
Study Start Date: | April 2005 |
Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm I: Experimental
Patients receive oral lenalidomide once daily on days 1-21.
|
Drug: lenalidomide
Given orally
|
Arm II: Experimental
Patients receive lenalidomide as in group one at a higher dose.
|
Drug: lenalidomide
Given orally
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed at 1 month, monthly for 2 months, and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 12-38 patients will be accrued for this study within 2-3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ocular melanoma
No evidence of active brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
Bethesda, Maryland, United States, 20892-1182 |
Principal Investigator: | Steven K. Libutti, MD | NCI - Surgery Branch |
Study ID Numbers: | CDR0000430670, NCI-05-C-0095, NCI-P6501 |
Study First Received: | June 2, 2005 |
Last Updated: | April 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00112606 History of Changes |
Health Authority: | United States: Food and Drug Administration |
ciliary body and choroid melanoma, medium/large size extraocular extension melanoma iris melanoma recurrent intraocular melanoma metastatic intraocular melanoma |
Eye Neoplasms Uveal Melanoma Eye Diseases Lenalidomide Melanoma of the Choroid Angiogenesis Inhibitors Recurrence Melanoma |
Neuroendocrine Tumors Ocular Melanoma Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Intraocular Melanoma Neuroepithelioma Nevus |
Neoplasms by Histologic Type Eye Neoplasms Antineoplastic Agents Eye Diseases Neoplasms, Nerve Tissue Lenalidomide Pharmacologic Actions Melanoma |
Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Nevi and Melanomas |