Physicians are currently seeking subjects to participate in this open-label, dose-escalation research study of an investigational agent. Eligible subjects will be hospitalized for 5 days. The investigational agent will be administered twice daily intravenously for four days. Subjects will then be monitored daily on an outpatient basis for a total of 10 additional days with a 30 day follow-up evaluation. Subjects with partial or complete remissions will have another follow-up visit on day 60, then every three months for 1 year, followed by annual visits to assess duration of the response. Approximately 30 patients will be enrolled in this study over two years.
Qualified subjects receive all evaluations and procedures related to the study at no cost, including physical examinations, laboratory tests, ECG and CT-scan. Blood draws and biopsies will be done periodically. Accommodations will be provided.
Inclusion Criteria includes:
• Age ≥ 18
• Diagnosis of T-cell Lymphoma
• Must be relapsed or refractory after receiving at least one prior topical or conventional therapy
• Patients must have CD3 on tumor cells
• No serious concurrent medical conditions, CNS disease, uncontrolled infections, MI in the last 6 months, or disseminated intravascular coagulopathy (DIC)
• Written informed consent
Cancer Research Institute
Scott & White
5701 South Airport Rd
Temple, TX 76508
Arthur Frankel, MD, Principal Investigator