Clinical Trial Alliance A091201
- Randomized Phase II Study Comparing the MET Inhibitor Cabozantinib to Temozolomide/Dacarbazine in Ocular Melanoma
- Principal Investigator
- Timothy Kuzel
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.Alliance A091201
- The purpose of this study is to test whether the new treatment with an experimental drug, known as cabozantinib is more effective than chemotherapy for treating ocular melanoma.
- Cabozantinib may work by blocking a protein called MET which is often found to be an important cause of the growth and spread of ocular melanoma.
Some of the eligibility criteria include:
- Participants must have ocular melanoma that has spread beyond the eye and/or it cannot be removed with surgery.
- Prior treatment is allowed, with the exception of drugs that target specific cell receptors. Please discuss all prior treatments with the study doctor.
- Participants must be 18 or older.
- Description of Treatment
- Participants will be "randomized" into one of the study groups described below. Those in Group 1 (often called "Arm 1") will receive cabozantinib. Cabozantinib is taken by mouth every day of a 28-day cycle. Those in Group 2 (often called "Arm 2") will receive temozolomide (or dacarbazine if temozolomide is not available). Temozolomide is taken by mouth on days 1-5 of a 28 days cycle. If temozolomide is not available, dacarbazine may be given as a replacement. If this happens dacarbazine will be given by intravenous (IV) (through a needle or tube inserted into a vein) infusion on day 1 of a 21-day cycle.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- A Randomized, Open-Label, Phase 3 Trial of brentuximab vedotin (SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma
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- A Randomized, Open-Label, Phase 3 Study of BMS-936558 vs. Everolimus in Subjects with Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy
- A Phase 1 Open-label Study of Safety and Tolerability of MEDI4736 in Subjects with Metastatic or Unresectable Melanoma in Combination with Dabrafenib and Trametinib or with Trametinib Alone
- A Phase 3, Randomized, Controlled Study of Cabozantinib (XL184) vs Everolimus in Subjects with Metastatic Renal Cell Carcinoma that has Progressed after Prior VEGFR Tyrosine Kinase Inhibitor Therapy
- A Randomized Phase II Trial of Sunitinib/Gemcitabine or Sunitinib in Advanced Renal Cell Carcinoma with Sarcomatoid Features
- A Phase II Trial of Dasatinib in Patients with Unresectable Locally Advanced or Stage IV Mucosal, Acral and Solar Melanomas
- Randomized, Double-Blind Phase III Study of Pazopanib vs. Placebo in Patients with Metastatic Renal Cell Carcinoma Who Have No Evidence of Disease Following Metastatectomy
- A Randomized Phase II Study of Ipilimumab at 3 mg/kg or 10 mg/kg Alone or in Combination with High Dose Interferon-a in Advanced Melanoma
- A Randomized Phase II Study of Sequential Biotherapy with Aflibercept and High Dose IL-2 versus High Dose IL-2 alone in Patients with Inoperable Stage III or Stage IV Melanoma: Efficacy and Biomarker Study
- A Randomized Phase I Dose-Escalation Trial of Carfilzomib with and without Romidepsin in Cutaneous T-Cell Lymphoma
- Phase II Trial of Everolimus or Everolimus plus Paclitaxel as First-line Therapy in Cisplatin-ineligible Patients with Advanced Urothelial Carcinoma (GU10-147)
- A Phase 1/2 study combining Ipilimumab with Abiraterone Acetate Plus Prednisone in Chemotherapy and Immunotherapy-Naïve Patients with Progressive Metastatic Castration-Resistant Prostate Cancer
last updated: 22-Dec-14 11:00 AM
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