Non Hodgkin Lymphoma Clinical Trial
RFT5-dgA Immunotoxin in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Non-Hodgkin Lymphoma
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.
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.
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
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)
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Dallas Texas, 75390, United States
How clear is this clinincal trial information?
Introducing, the Journey Bar
Use this bar to access information about the steps in your cancer journey.