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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00667017
First received: April 24, 2008
Last updated: February 4, 2010
Last verified: February 2010
  Purpose

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
Lymphoma
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:

OBJECTIVES:

Primary

  • 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) .

Secondary

  • 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.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667017

Locations
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
Investigators
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
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunotoxins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014