Lenalidomide, Sunitinib, and Cyclophosphamide in Treating Patients With Stage IV Eye Melanoma (NCT00482911) | Clinical Trial Compass
TerminatedPhase 2
Lenalidomide, Sunitinib, and Cyclophosphamide in Treating Patients With Stage IV Eye Melanoma
Stopped: Investigator left the institute.
United States12 participantsStarted 2007-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Response Rate (Complete and Partial Response)
Timeframe: 2 years
2
Toxicity
Timeframe: 16 months
3
Overall Survival
Timeframe: up to 16 months
Trial details
NCT IDNCT00482911
SponsorNational Institutes of Health Clinical Center (CC)