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

• Sponsor: University of Texas Southwestern Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00667017
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Arm: 1
• Actual Duration (Months): 14.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Biological: RFT5-dgA immunotoxin; Other: fluorescence activated cell sorting; Other: immunohistochemistry staining method	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study of IMTOX25 in Relapsed/Refractory Cutaneous T-Cell Lymphoma
• Actual Study Start Date: Nov 7, 2008
• Actual Primary Completion Date: Feb 1, 2010
• Actual Study Completion Date: Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Biological: RFT5-dgA immunotoxin; Other: fluorescence activated cell sorting; Other: immunohistochemistry staining method

Outcome Measures

Primary Outcome Measures

1. Response Rate - Cutaneous T Cell Lymphoma (CTCL) [Once a week for seven weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas	United States	75390

Sponsors and Collaborators

• University of Texas Southwestern Medical Center

Investigators

• Principal Investigator: Simrit Parmar, MD, Simmons Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT00667017
• Other Study ID Numbers: SCCC-02407; CDR0000594170; SCCC-122007-014
• First Posted: Apr 25, 2008
• Last Update Posted: Dec 14, 2018
• Last Verified: Nov 1, 2018

• Keywords provided by University of Texas Southwestern Medical Center: recurrent mycosis fungoides/Sezary syndrome; recurrent cutaneous T-cell non-Hodgkin lymphoma
• Additional relevant MeSH terms: Lymphoma; Lymphoma, T-Cell, Cutaneous; Immunotoxins

Study Results

Participant Flow

Recruitment Details	Consent Withdrawn After Treatment Started. Pt withdrew from treatment due to side effects

Arm/Group Title	IMTOX25 at 2mg/m²/Dose
Arm/Group Description	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. RFT5-dgA immunotoxin fluorescence activated cell sorting immunohistochemistry staining method
Period Title: Overall Study
STARTED	1
COMPLETED	0
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	IMTOX25 at 2mg/m²/Dose
Arm/Group Description	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. RFT5-dgA immunotoxin fluorescence activated cell sorting immunohistochemistry staining method
Overall Participants	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Age () []
Sex: Female, Male () []
Female
Male
Region of Enrollment (participants) []

Outcome Measures

1. Primary Outcome

Title	Response Rate - Cutaneous T Cell Lymphoma (CTCL)
Description	Response rate of patients with relapsed/refractory Cutaneous T Cell Lymphoma (CTCL) following treatment with IMTOX25.
Time Frame	Once a week for seven weeks

Outcome Measure Data

Analysis Population Description

Consent Withdrawn After Treatment Started Pt withdrew from treatment due to side effects.

Arm/Group Title	IMTOX25 at 2mg/m²/Dose
Arm/Group Description	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. RFT5-dgA immunotoxin fluorescence activated cell sorting immunohistochemistry staining method
Measure Participants	0

Adverse Events

Arm/Group Title	IMTOX25 at 2mg/m²/Dose
Arm/Group Description	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. RFT5-dgA immunotoxin fluorescence activated cell sorting immunohistochemistry staining method
All Cause Mortality
	IMTOX25 at 2mg/m²/Dose
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
Serious Adverse Events
	IMTOX25 at 2mg/m²/Dose
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
Other (Not Including Serious) Adverse Events
	IMTOX25 at 2mg/m²/Dose
	Affected / at Risk (%)	# Events
Total	0/1 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.