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Dallas, Texas 75390


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.

Study summary:

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.


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)



Primary Contact:

Principal Investigator
Simrit Parmar, MD
Simmons Cancer Center

Backup Contact:


Location Contact:

Dallas, Texas 75390
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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