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

NCT00667017 | Terminated Phase 2 Results

• 3 other identifiers: SCCC-02407CDR0000594170SCCC-122007-014
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Response Rate - Cutaneous T Cell Lymphoma (CTCL)

  Response rate of patients with relapsed/refractory Cutaneous T Cell Lymphoma (CTCL) following treatment with IMTOX25.

  Once a week for seven weeks

Study Arms (1)

IMTOX25 at 2mg/m²/dose

EXPERIMENTAL

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.

Biological: RFT5-dgA immunotoxin; Other: fluorescence activated cell sorting; Other: immunohistochemistry staining method

Interventions

RFT5-dgA immunotoxin BIOLOGICAL

IMTOX25 at 2mg/m²/dose

fluorescence activated cell sorting OTHER

IMTOX25 at 2mg/m²/dose

immunohistochemistry staining method OTHER

IMTOX25 at 2mg/m²/dose

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

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

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Lymphoma; Mycosis Fungoides; Sezary Syndrome; Lymphoma, T-Cell, Cutaneous

Interventions

RFT5-SMPT-dgA immunotoxin; Flow Cytometry; Immunohistochemistry

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Histocytochemistry; Histological Techniques; Immunologic Techniques

Results Point of Contact

• Title: Larry Andeson, MD
• Organization: University of Texas Southwestern Medical Center

214-648-7097

Study Officials

• Simrit Parmar, MD

  Simmons Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 25, 2008
• Study Start: November 7, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: December 14, 2018
• Results First Posted: December 14, 2018

Record last verified: 2018-11

Locations

US (1)