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Sponsored by: |
Simmons Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00667017 |
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.
Condition | Intervention | Phase |
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Lymphoma |
Biological: RFT5-dgA immunotoxin Other: fluorescence activated cell sorting Other: immunohistochemistry staining method |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | Phase II Study of IMTOX25 in Relapsed/Refractory Cutaneous T-Cell Lymphoma |
Estimated Enrollment: | 29 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Relapsed or refractory disease, meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
No history of uncontrolled concurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
United States, Texas | |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Recruiting |
Dallas, Texas, United States, 75390 | |
Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a 866-460-4673; 214-648-7097 |
Principal Investigator: | Simrit Parmar, MD | Simmons Cancer Center |
Responsible Party: | UT Southwestern University Hospital - Zale Lipshy ( Ellen Vitetta ) |
Study ID Numbers: | CDR0000594170, SCCC-02407, SCCC-122007-014 |
Study First Received: | April 24, 2008 |
Last Updated: | February 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00667017 History of Changes |
Health Authority: | Unspecified |
recurrent mycosis fungoides/Sezary syndrome recurrent cutaneous T-cell non-Hodgkin lymphoma |
Immunoproliferative Disorders Immunologic Factors Sezary Syndrome Mycosis Fungoides Immunotoxins Recurrence Lymphoma, Small Cleaved-cell, Diffuse Mycoses |
Lymphatic Diseases Cutaneous T-cell Lymphoma Lymphoma, T-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Lymphoma, T-Cell, Cutaneous |
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Immunotoxins |
Lymphatic Diseases Neoplasms Lymphoma, T-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Lymphoma, T-Cell, Cutaneous |