Status:
TERMINATED
RFT5-dgA Immunotoxin in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Non-Hodgkin Lymphoma
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Lymphoma
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief 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 tri...
Detailed 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 immuno...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
November 7 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00667017
Start Date
November 7 2008
End Date
February 1 2010
Last Update
December 14 2018
Active Locations (1)
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1
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390