Protocol Number: 07-C-0134

Title:

A Phase II Study of Combination Oral CC-5013 Lenalidomide (Revlimid ® (Registered Trademark)), Oral Sunitinib (Sutent) and Low Dose Oral Metronomic Cyclophosphamide for the Treatment of Stage IV Ocular Melanoma

Number:

07-C-0134

Summary:

Background:

Patients with advanced ocular melanoma (a rare form of eye cancer) have very few treatment options.

Recent research shows that combinations of lenalidomide, sunitinib and cyclophosphamide can slow tumor growth in mice.

Objectives:

To determine if combination therapy with lenalidomide, sunitinib and cyclophosphamide can reduce tumor size and prolong survival in patients who have metastatic ocular melanoma (ocular melanoma that has spread beyond the eye).

Eligibility:

Patients 18 years of age and older with stage IV ocular melanoma.

Design:

Patients take lenalidomide, sunitinib and cyclophosphamide daily in 28-day cycles for up to 2 years.

Patients keep a record (diary) of their daily dosing, side effects of the medicines and any other health problems that may develop during the study period. They fax this diary to researchers at the end of each treatment cycle.

In addition, patients have the following tests and procedures:

-Blood tests, scans and x-rays at the end of each cycle to monitor the cancer.

-Visits to NIH every month for 4 months and then every 4 months until the study ends for evaluations, which include a physical examination, blood tests, and review of their diary.

-MRI and CT scans of the brain every year.

-Tumor biopsies (surgical removal of a small piece of tumor tissue, if the tumor is easy to biopsy) to examine the effect of the study drugs on the cancer. Biopsies may be done before starting the study drugs and again at the end of the first and second treatment cycles.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: No longer recruiting/follow-up only

Gender: Male & Female

Referral Letter Required: No

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):

Metastatic Melanoma

Anti-Angiogenic Therapy

Mechanism of Action

Targeted Therapy

Recruitment Keyword(s):

Melanoma

Metastatic Melanoma

Ocular Melanoma

Condition(s):

Ocular Melanoma

Investigational Drug(s):

Lenalidomide

Investigational Device(s):

None

Interventions:

Drug: Lenalidomide

Drug: Sunitinib

Drug: Cyclophosphamide

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):

Tuomaala S, Eskelin S, Tarkkanen A, Kivela T. Population-based assessment of clinical characteristics predicting outcome of conjunctival melanoma in whites. Invest Ophthalmol Vis Sci. 2002 Nov;43(11):3399-408.

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.

• 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.

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