A-dmDT390-bisFv (UCHT1) Immunotoxin Therapy for Patients With T-cell Diseases
This is a Phase I/II clinical trial aimed at treating patients with T-cell lymphomas (T-cell blood cancers). The drug consists of a toxin, called diphtheria toxin, which is attached to an antibody that can specifically target cancerous T-cells. As this is a Phase I/II trial, it has not been tested in humans. Our primary objectives are, therefore, to determine how much of the drug can be given to an individual and what are the toxicities associated with the drug. It is anticipated that approximately 40 patients will be enrolled in this study over two years. Patients will receive full supportive care during the course of the study. Participation in the study will require a 5 day stay in the hospital, as well as frequent (2-3 times/week) outpatient labs (blood draws) for the first 30 days. Patients with partial or complete remissions at their 1 month follow up visit 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.
Biological: A-dmDT390-bisFv (UCHT1)
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study of A-dmDT390-bisFv (UCHT1) Fusion Protein in Patients With Surface CD3+ Malignant T Cell Diseases|
- Remission status (complete, partial, stable disease, progressive disease) [ Time Frame: Time Frame: 6 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Biological: A-dmDT390-bisFv (UCHT1)
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 CD3ε surface membrane protein found on malignant T-cells. It is anticipated that approximately 40 patients will be enrolled in this study over two years. 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. Patients will be hospitalized for 5 days (4 day administration cycle of A-dmDT390-bisFv (UCHT1))and will be monitored two to three times weekly for 30 days. 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.
- Determine the maximal tolerated dose (MTD) of A-dmDT390-bisFv (UCHT1) fusion protein as a bolus infusion on days 1-4 in patients with CD3+ T-cell malignant diseases.
- Define the dose-limiting toxicities (DLTs) of this A-dmDT390-bisFv (UCHT1) regimen in patients with CD3+ T-cell malignant diseases.
- Measure the pharmacokinetics, immune responses, and cytokine responses to this course of bolus infusions of A-dmDT390-bisFv (UCHT1) fusion protein.
- Evaluate responses and correlate with the in vitro sensitivity of patient malignant T-cells to A-dmDT390-bisFv (UCHT1).
- Determine the extent and kinetics of resting and malignant T-cell depletion and repopulation in the treatment groups by flow cytometry of samples obtained from blood and marrow aspirations.
|Contact: David Neville, MDemail@example.com|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77230|
|Contact: Carol Wilson, RN 713-563-4655 firstname.lastname@example.org|
|Contact: Vicki Jeanis, RN 713-745-0367 email@example.com|
|Principal Investigator: Madeleine Duvic, MD|
|Sub-Investigator: Susan O'Brien, MD|
|Scott and White Hospital and Clinic||Recruiting|
|Temple, Texas, United States, 76508|
|Contact: Margarite Grable, CCRP 254-724-0292 firstname.lastname@example.org|
|Contact: David Neville, MD 240-383-2589 email@example.com|
|Principal Investigator: Arthur E Frankel, MD|
|Study Chair:||Arthur E Frankel, MD||Cancer Research Institute of Scott and White Memorial Hospital|