This is a Phase I/II, open-label, dose-escalation, multi-dose study of A-dmDT390-bisFv(UCHT1) Fusion Protein, an antibody tagged with diphtheria toxin targeting CD3 ε surface membrane protein found on malignant T-cells. Patients will receive full supportive care including transfusions of irradiated washed blood and blood products, antibiotics, antiemetics, etc, when appropriate. However, other anti-neoplastic drugs or hematopoietic growth factors (e.g., erythropoietin, interleukin-11, G-CSF and GM-CSF) are not allowed. Treatment will consist of one 4 day cycle consisting of 2 daily infusions for a total of 8 treatments. Patients will be monitored until day 14 for signs of late drug toxicity by a daily phone call from their health care provider. Subjects will be instructed on how to monitor their own blood pressure at home and encouraged to measure and chart their daily weights that they can report to their health care provider. Off-treatment follow-up will be based upon response. Patients will then have a follow-up visit and testing on day 30. Patients 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.
Travel & Lodging Defrayment
As a result of study participation, travel will be requested to a participating medical center. Angimmune (the study sponsor) will partially pay to defray travel & lodging costs for a family member to accompany a patient to this trial. Please contact the appropriate Clinical Research Coordinator at the trial site listed below for more information.
Universtiy of Louisville - James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
Principal Investigator: Cesar Rodriguez, MD
Clinical trial contact information: David Figg, SC
Brown Cancer Center Clinical Trials Office
Please refer to this study by its ClinicalTrials.gov identifier: NCT00611208