Clinical Trial DRUG 0761-010
- Open-Label, Multi-Center, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 (mogamulizumab) Versus Vorinostat in Subjects with Previously Treated Cutaneous T-Cell Lymphoma
- Principal Investigator
- Timothy Kuzel
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG 0761-010
- The purpose of this study is threefold. First, to determine if KW-0761 will work in treating cutaneous T-cell lymphoma (CTCL) that has not responded to other treatments. Second, to evaluate the side effects (good and/or bad) of KW-0761. Third, to compare treatment of CTCL with KW-0761 to treatment with vorinstat.
- KW-0761 is an investigational drug. An investigational drug is one which has not been approved by the U.S. Food and Drug Administration (FDA). KW-0761 is an antibody. Antibodies are proteins which the immune system, your body’s defense system, uses to recognize foreign or unwanted material, such as infection or some cancers. Antibodies are used to try to destroy cancer cells while causing little harm to normal cells. The cancer cells of many patients with T-cell lymphoma contain a protein called CCR4. KW-0761 finds T-cells that CCR4 on their surface and attempts to destroy them. KW-0761 will be tested in this study versus vorinostat which is a FDA approved drug for CTCL.
Some of the eligibility criteria include:
- Participants must have had at least one prior therapy for CTCL.
- Participants must be 18 years of age or older.
- Participants must have confirmed diagnosis of Mycosis Fungoides (MF) or Sezary Syndrome (SS). Both MF and SS are forms of cutaneous T-cell lymphoma.
- Description of Treatment
- Participants will either be assigned to the KW-0761 or the vorinstat group by a computer program designed to consider each participant's disease. Neither the participant or the doctor can choose which treatment group participants will be assigned to. Vorinostat is an established standard treatment for CTCL. Each group will receive treatment for 4 weeks and then be re-assessed to see how the treatment is working. If there is disease progression (it has gotten worse) and the participant is in the vorinostat group, they may be allowed to receive KW-0761. Participants may continue on treatment until disease progression or until the study doctor feels it is in their best interest to stop.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- 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)
last updated: 13-Oct-15 03:54 AM
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