RFT5-dgA Immunotoxin in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Non-Hodgkin Lymphoma

This study has been completed.
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
First received: April 24, 2008
Last updated: February 4, 2010
Last verified: February 2010

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
Biological: RFT5-dgA immunotoxin
Other: fluorescence activated cell sorting
Other: immunohistochemistry staining method
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]
  • Overall response (CR, PR, or SD) as defined by RECIST criteria [ Designated as safety issue: No ]
  • Toxicities [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 29
Study Start Date: July 2008
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Detailed Description:



  • 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Histologically confirmed cutaneous T-cell non-Hodgkin lymphoma (CTCL)
  • Relapsed or refractory disease, meeting 1 of the following criteria:

    • Progression of disease following 2 prior chemotherapies
    • Failure to respond to the second prior chemotherapy
  • Measurable disease


  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • Serum creatinine < 1.5 times upper limit of normal (ULN)
  • Serum AST/ALT < 2.5 times ULN
  • Total bilirubin ≤ 2.0 mg/dL (< 3.0 mg/dL in patients with Gilbert syndrome)
  • WBC count ≥ 3,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Serum albumin > 2.5 g/dL
  • LVEF ≥ 45% by 2-D ECHO or MUGA scan
  • Human antimurine antibody < 1 μg/mL
  • Patients with a history of electrocardiogram abnormalities, symptoms of cardiac ischemia, or arrhythmias must have a normal cardiac stress test (i.e., stress thallium, stress MUGA, dobutamine echocardiogram, or other stress test)
  • Must be willing to undergo venipuncture and central line placement
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No HBV surface antigen, HCV, or HIV antibody positivity
  • No autoimmune disease or immunodeficiency (i.e., HIV)
  • No history of uncontrolled concurrent illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • Ongoing or active cardiac disease (i.e., congestive heart failure, unstable angina pectoris, or cardiac arrhythmia)
    • Psychiatric illness and/or social situation that would preclude study compliance
  • No other malignancies except treated basal cell or squamous cell carcinoma of the skin, or treated carcinoma in situ of the cervix


  • See Disease Characteristics
  • More than 3 weeks since prior systemic therapy for CTCL
  • More than 6 months since prior chronic steroid therapy or chronic anti-coagulation therapy
  • No prior therapy with anti-CD25 immunotoxin IMTOX25 and/or Ontak
  • No other concurrent cancer chemotherapy, experimental therapy, investigational agent, or immunomodulating agent (including steroids)
  Contacts and Locations
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
Sponsors and Collaborators
Simmons Cancer Center
Principal Investigator: Simrit Parmar, MD Simmons Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Ellen Vitetta, UT Southwestern University Hospital - Zale Lipshy
ClinicalTrials.gov Identifier: NCT00667017     History of Changes
Other Study ID Numbers: CDR0000594170, SCCC-02407, SCCC-122007-014
Study First Received: April 24, 2008
Last Updated: February 4, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent mycosis fungoides/Sezary syndrome
recurrent cutaneous T-cell non-Hodgkin lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014