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

Phase 2
18 Years
Not Enrolling

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Trial Information

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



- 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.

Inclusion Criteria


- 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

- 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)

Type of Study:


Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Safety Issue:


Principal Investigator

Simrit Parmar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Simmons Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

July 2008

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous



Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390