RFT5-dgA Immunotoxin in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Non-Hodgkin Lymphoma
RATIONALE: Immunotoxins, such as RFT5-dgA immunotoxin (also called anti-CD25 immunotoxin IMTOX25), can find certain cancer cells and kill them without harming normal cells.
PURPOSE: This phase II trial is studying the side effects of anti-CD25 immunotoxin IMTOX25 and how well it works in treating patients with relapsed or refractory cutaneous T-cell non-Hodgkin lymphoma.
|Lymphoma||Biological: RFT5-dgA immunotoxin Other: fluorescence activated cell sorting Other: immunohistochemistry staining method||Phase 2|
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of IMTOX25 in Relapsed/Refractory Cutaneous T-Cell Lymphoma|
- Response rate
- Overall response (CR, PR, or SD) as defined by RECIST criteria
- Progression-free survival
|Study Start Date:||July 2008|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
- Determine the response rate of patients with relapsed or refractory cutaneous T-cell non-Hodgkin lymphoma (CTCL) following treatment with RFT5-dgA immunotoxin (anti-CD25 immunotoxin IMTOX25) .
- Determine whether responses correlate with the level of CD25+ expression on the CTCL tumor cells.
- Determine whether changes in the pre-treatment and the post-treatment levels of CD4+CD25+ Treg cells correlate with responses.
OUTLINE: Patients receive anti-CD25 immunotoxin IMTOX25 IV over 4 hours on days 1, 3, and 5. Treatment repeats every 6 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Tissue and blood samples are collected at baseline, and during study for CD25+ expression by fluorescent-activated cell sorter analysis, immunohistochemistry.
After completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00667017
|United States, Texas|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Simrit Parmar, MD||Simmons Cancer Center|