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 range18 Years
SexALL
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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.
✓. 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.
What they're measuring
1
Overall Response Rate (Percentage Subjects With Confirmed Complete or Partial Response)
. 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.