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

Lymphoma Clinical Trial

Official title:

Phase II Study of IMTOX25 in Relapsed/Refractory Cutaneous T-Cell Lymphoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00667017
• Other study ID #: SCCC-02407
• Secondary ID: CDR0000594170SCC
• Status: Terminated
• Phase: Phase 2
• Start date: November 7, 2008
• Est. completion date: February 2010

Study information

• Verified date: November 2018
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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)

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous

Intervention

Biological:
• RFT5-dgA immunotoxin

Other:
• fluorescence activated cell sorting

• immunohistochemistry staining method

Locations

Country	Name	City	State
United States	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate - Cutaneous T Cell Lymphoma (CTCL)	Response rate of patients with relapsed/refractory Cutaneous T Cell Lymphoma (CTCL) following treatment with IMTOX25.	Once a week for seven weeks