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

NCT ID: NCT00667017

Last Updated: 2018-12-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-07
• Study Completion Date: 2010-02-28

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.

Conditions

Lymphoma

Keywords

recurrent mycosis fungoides/Sezary syndrome; recurrent cutaneous T-cell non-Hodgkin lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IMTOX25 at 2mg/m²/dose

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.

Group Type: EXPERIMENTAL

RFT5-dgA immunotoxin

Intervention Type: BIOLOGICAL

fluorescence activated cell sorting

Intervention Type: OTHER

immunohistochemistry staining method

Intervention Type: OTHER

Interventions

RFT5-dgA immunotoxin

Intervention Type: BIOLOGICAL

fluorescence activated cell sorting

Intervention Type: OTHER

immunohistochemistry staining method

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simrit Parmar, MD

Role: PRINCIPAL_INVESTIGATOR

Simmons Cancer Center

Locations

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, United States

Countries

United States

Other Identifiers

CDR0000594170

Identifier Type: REGISTRY

Identifier Source: secondary_id

SCCC-122007-014

Identifier Type: -

Identifier Source: secondary_id

SCCC-02407

Identifier Type: -

Identifier Source: org_study_id