RFT5-dgA Immunotoxin in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Non-Hodgkin Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell, Cutaneous
Intervention: RFT5-dgA immunotoxin; fluorescence activated cell sorting; immunohistochemistry staining method
Intervention MeSH terms: Immunotoxins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent mycosis fungoides/Sezary syndrome; recurrent cutaneous T-cell non-Hodgkin lymphoma

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.
    

Eligibility 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)