Clinical trial NCT00667017: RFT5-dgA Immunotoxin in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Non-Hodgkin Lymphoma
Official title: Phase II Study of IMTOX25 in Relapsed/Refractory Cutaneous T-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lymphoma
Keywords: recurrent mycosis fungoides/Sezary syndrome
recurrent cutaneous T-cell non-Hodgkin lymphoma
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2008-04-25
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 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.

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)

Primary outcomes:
measure: Response Rate - Cutaneous T Cell Lymphoma (CTCL)
timeFrame: Once a week for seven weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
state: Texas
Study officials:
affiliation: Simmons Cancer Center
name: Simrit Parmar, MD
role: PRINCIPAL_INVESTIGATOR
References: