Clinical Trial DRUG E7777-G000-302
- A Clinical Study to Demonstrate Safety and Efficacy of E7777 (Denileukin Diftitox) in Persistent or Recurrent Cutaneous T-Cell Lymphoma
- Principal Investigator
- Timothy Kuzel
- Status: SUSPENDED
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG E7777-G000-302
- The purpose of this study is to evaluate the effects, good and/or bad, of the drug E7777 in the treatment of persistent (continuous) or recurrent (disease keeps coming back) cutaneous T-cell lymphoma (CTCL).
- CTCL is a rare form of skin cancer. When CTCL is persistent or recurrent the medical and scientific community is always looking for new treatments that may have success with controlling this cancer. E7777 is an investigational drug (it has not been approved by the Food and Drug Administration). There is not yet evidence of the benefits of E7777.
Some of the eligibility criteria include:
- Participants must be 18 years of age or older.
- Participants must have confirmed CTCL (mycosis fungoides [MF] or Sezary Syndrome [SS]).
- Participants must have had prior therapy for CTCL.
- Description of Treatment
- This study has two parts. The first part (the Lead-In part) will evaluate different doses of E7777. The second part (the Main Study) will assess E7777’s ability to control CTCL and will start after the end of the Lead-In part of the study. Participants in the Lead-In part of the study will receive the study drug by intravenous (IV through a vein) for 5 straight days every 3 weeks. Each 3 week period is called a cycle. Participants may continue up to 8 cycles (24 weeks) of treatment at most or be taken off treatment before that if their disease worsens or the study doctor thinks 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 II Trial of Dasatinib in Patients with Unresectable Locally Advanced or Stage IV Mucosal, Acral and Solar Melanomas
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- 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
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- 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)
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last updated: 01-Mar-15 09:29 PM
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