Genasense, Carboplatin, Paclitaxel (GCP) Combination in Uveal Melanoma
Stopped: Pharmaceutical company no longer manufacturing investigational product.
United States7 participantsStarted 2010-12
Plain-language summary
The goal of this clinical research is to learn if the combination of Genasense (oblimersen), carboplatin, and paclitaxel (GCP) can help to control metastatic uveal melanoma. The safety of this combination will also be studied.
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.
Inclusion criteria
. Patients must have a history of uveal melanoma and documented metastatic disease
. Patients must have at least one measurable lesion as per revised RECIST Criteria. A measurable lesion is defined as a non-nodal lesions that is \>/= 10 mm provided the CT slice is \</=5 mm in thickness or a pathologic lymph node that is \>/= 15 mm on the short axis provided the CT slice is \</= 5 mm in thickness or Superficial skin lesion that is \>/= 10 mm in diameter as assessed using calipers. Bone lesions are not considered measurable.
. Patients may be previously untreated or may have received prior systemic therapy but no more than one systemic cytotoxic chemotherapy regimen and one targeted therapy for metastatic disease.
. 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 before starting GCP therapy.
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
Overall Response Rate (Percentage Subjects With Confirmed Complete or Partial Response)
. At least 4 weeks (28 days) since prior radiotherapy to \> 20% of the bone marrow.
. Lesions being used to assess disease status may not have been radiated or if so, must have progressed during or after radiation therapy.
. Patients must have ECOG performance status of 0 - 2.
. Patients should be 18 years of age or older.
Exclusion criteria
. Patients who have received prior therapy with Genasense, any taxane or any of cisplatin analogues for systemic disease.
. Patients whose site of primary melanoma is not in the choroid.
. Patients who have a current history of neoplasm other than the entry diagnosis, except for curatively treated non-melanoma skin cancer or carcinoma in situ of the prostate or cervix or other cancers treated for cure and with a disease-free survival longer than 2 years.
. Patients with brain metastasis or history of brain metastasis (es).
. Patients who are pregnant or breastfeeding.
. Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals).
. Patients with current peripheral neuropathy of any etiology that is greater than grade one (1).
. Patients with unstable or serious concurrent medical conditions are excluded. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent. PI or his designee shall make the final determination regarding appropriateness of enrollment.