Protocol Number: 05-C-0095

Title:

A Randomized Phase II Study of Oral Lenalidomide (Revlimid [TM]), an Antiangiogenic and Immunomodulatory Agent, in Subjects with Stage IV Ocular Melanoma

Number:

05-C-0095

Summary:

Background:

Patients with advanced ocular melanoma have very few available treatment options.

Early studies suggest that lenalidomide may be effective against tumors.

Objectives:

To determine whether lenalidomide reduces tumor size and prolongs survival in patients with advanced ocular melanoma.

To study the toxicity and blood effects of lenalidomide in these patients.

Eligibility:

Patients 18 years of age and older with advanced ocular melanoma.

Design:

76 patients with advanced ocular melanoma will be enrolled over 4 to 5 years.

Participants are randomly assigned to receive one of two doses of lenalidomide by mouth in 28-day treatment cycles for up to 2 years. One cycle consists of 21 days on drug followed by a 7-day rest.

Patients are monitored with the following:

-Weekly blood tests

-24-hour urine collection the first treatment cycle.

-Periodic visits to NIH for blood tests, physical examination, and scans and x-rays to evaluate the tumor. Visits are scheduled every month for 3 months, then every 3 months until 2 years after stopping treatment, then every 4 months for 1 year and as needed after that.

-Tumor biopsy (optional).

-Brain magnetic resonance imaging (MRI) yearly to watch for new areas of tumor.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: No longer recruiting/follow-up only

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Response Rate

Toxicity

Progression-Free Survival

Overall Survival

Pharmacokinetic

Recruitment Keyword(s):

Ocular Melanoma

Condition(s):

Melanoma

Investigational Drug(s):

CC-5013 Revlimid

Investigational Device(s):

None

Interventions:

Drug: CC-5013 Revlimid

Drug: CC-5013 Revlimid

Supporting Site:

National Cancer Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Shields CL, Shields JA, Gunduz K, Cater J, Mercado GV, Gross N, Lally B. Conjunctival melanoma: risk factors for recurrence, exenteration, metastasis, and death in 150 consecutive patients. Arch Ophthalmol. 2000 Nov;118(11):1497-507.

Shields CL, Naseripour M, Cater J, Shields JA, Demirci H, Youseff A, Freire J. Plaque radiotherapy for large posterior uveal melanomas (> or =8-mm thick) in 354 consecutive patients. Ophthalmology. 2002 Oct;109(10):1838-49.

Gragoudas ES, Egan KM, Seddon JM, Glynn RJ, Walsh SM, Finn SM, Munzenrider JE, Spar MD.Survival of patients with metastases from uveal melanoma.Ophthalmology. 1991 Mar;98(3):383-9; discussion 390.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home

National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/30/2009