Lenalidomide, Sunitinib, and Cyclophosphamide in Treating Patients With Stage IV Eye Melanoma

• Status: Terminated
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Lenalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with sunitinib and low doses of cyclophosphamide once a day may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving lenalidomide together with sunitinib and cyclophosphamide works in treating patients with stage IV eye melanoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institutes of Health Clinical Center (CC)
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Lenalidomide; Sunitinib; Thalidomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed ocular melanoma

• Stage IV disease

• Measurable disease

• No active brain metastases

• Patients with brain metastases must have had a complete excision or radiotherapy and remain asymptomatic with stable disease by magnetic resonance imaging (MRI) or computed tomography (CT) scan for ≥ 6 months

PATIENT CHARACTERISTICS:

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Life expectancy > 3 months

• Granulocyte count > 1,500/mm^3

• Platelet count > 100,000/mm^3

• Creatinine ≤ 1.5 mg/dL OR creatinine clearance > 60 mL/min

• Bilirubin ≤ 2.0 mg/dL

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 10 times upper limit of normal (ULN)

• Prothrombin time (PT)/partial thromboplastin time (PTT)/International Normalized Ratio (INR) normal

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use one highly effective method of contraception (with an additional method) or barrier methods of contraception for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study therapy

• Ejection fraction normal by echocardiogram

• No acute, critical illness, including serious untreated infection

• No history of any of the following:

• Unstable or newly diagnosed angina pectoris

• Myocardial infarction within the past 6 months

• New York Heart Association class II-IV heart disease

• Congestive heart failure

• Chronic obstructive lung disease requiring oxygen therapy

• Chronic uncontrollable hypertension

• Uncontrolled seizure activity

• No known human immunodeficiency virus (HIV) positivity

• No known hypersensitivity reaction to thalidomide, lenalidomide, sunitinib malate, or cyclophosphamide

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Recovered from all prior therapy

• At least 4 weeks since prior surgery, chemotherapy (6 weeks for mitomycin C, nitrosoureas, or carboplatin), hormonal therapy, radiotherapy, or biological therapy

• No concurrent grapefruit or grapefruit juice

• No other concurrent antitumor therapy