Cixutumumab in Treating Patients With Metastatic Melanoma of the Eye (NCT01413191) | Clinical Trial Compass
CompletedPhase 2
Cixutumumab in Treating Patients With Metastatic Melanoma of the Eye
United States18 participantsStarted 2011-08
Plain-language summary
This phase II trial studies how well giving cixutumumab works in treating patients with metastatic melanoma of the eye. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
Who can participate
Age range
17 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.
Inclusion Criteria:
* Patients must have a history of uveal melanoma and documented metastatic disease
* Patients must have at least one unidimensionally measurable lesion; if this is a cutaneous lesion it must be at least 10 mm by caliper measure; if it is a visceral or nodal or soft tissue lesion, it must be clearly measurable \> 20 mm with conventional techniques or \> 10 mm with spiral CT scan; bone lesions are not considered measurable
* One prior systemic chemotherapy and any number of immunotherapies or vaccine therapies are allowed; prior treatment with hepatic arterial chemotherapy infusion or perfusion or chemoembolization of liver metastasis is allowed; prior treatment with radiation therapy is allowed but not more than 3000 cGy to fields including substantial marrow; patients are not required to have had prior therapy
* At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine or other therapy unless patients have progressed during therapy; if progression occurred during therapy, patient must have recovered from any side effects
* At least 4 weeks (28 days) since prior radiotherapy and prior adjuvant chemotherapy
* Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
* Patients must have a life expectancy of at least 3 months
* Leukocytes \> 3,000/mm3
* Absolute neutrophil count ≥ 1,500/mm3
* Hemoglobin ≥ 9.0 g/dL
* Platelets ≥ 100,000/mm3
* Aspartate transaminase-alanine transaminase ratio (AST…
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.