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

The University of Texas System (UT)

Status and phase: Terminated; Phase 2

Conditions: Lymphoma

Treatments: Biological: RFT5-dgA immunotoxin; Other: fluorescence activated cell sorting; Other: immunohistochemistry staining method

Study type: Interventional

Funder types: Other

Identifiers

NCT00667017

SCCC-02407

SCCC-122007-014

CDR0000594170 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

IMTOX25 at 2mg/m²/dose

Experimental group

Description:

Patients will receive IMTOX25 at 2mg/m²/dose, by IV administration, every other day for a total of 3 doses. A total of 6 cycles of treatment will be allowed. A cycle is equal to 6 weeks, with IMTOX25 infusion on Day 1, 3 and 5, followed by a 5 week rest period.

Treatment:

Other: immunohistochemistry staining method

Biological: RFT5-dgA immunotoxin

Other: fluorescence activated cell sorting