Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

LMB-2 Immunotoxin in Treating Patients With Cutaneous T-Cell Lymphoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 18 and over NCI NCI-04-C-0142 NCI-5943, NCT00085085

Special Category: NIH Clinical Center trial, NCI Web site featured trial

Objectives

Primary

1. Determine the response rate and response duration in patients with CD25-positive cutaneous T-cell lymphoma treated with LMB-2 immunotoxin.

Secondary

1. Determine the relationship between immunogenicity, toxicity, and serum concentration of this drug in these patients.
2. Correlate soluble Tac-peptide (sIL2Rα) levels with response in patients treated with this drug.

Entry Criteria

Disease Characteristics:

• Histologically confirmed cutaneous T-cell lymphoma (CTCL)
  • Stage IB-IV disease
  • CD25-positive disease* meeting at least 1 of the following criteria:
    • At least 20% expression of CD25 on the lymphocytes in the skin at a site of a patch, plaque, or tumor
    • At least 20% of the peripheral blood Sézary cells must be CD25-positive

   [Note: *CD25 expression status must have been determined within the past year]




• Disease progression after at least 2 prior systemic or topical therapies



• Measurable disease

Prior/Concurrent Therapy:

Biologic therapy

• More than 4 weeks since prior monoclonal antibodies

Chemotherapy

• Not specified

Endocrine therapy

• Concurrent prednisone ≤ 20 mg/day (or equivalent dose of another steroid) allowed if on stable dose for ≥ 3 weeks and disease has progressed

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• At least 3 weeks since prior therapy for CTCL (with evidence of disease progression)
• At least 4 days since prior warfarin
• No concurrent warfarin
  • Heparin or low-molecular weight heparin allowed

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,000/mm³ (500/mm³ if blood or bone marrow involvement)
• Platelet count ≥ 50,000/mm³ (10,000/mm³ if blood or bone marrow involvement)

Hepatic

• AST and ALT ≤ 2.5 times upper limit of normal
• Albumin ≥ 3.0 g/dL
• Bilirubin ≤ 2.2 mg/dL
• Hepatitis B surface antigen negative
• Hepatitis C negative by polymerase chain reaction
• No chronic liver disease

Renal

• Creatinine ≤ 2.0 mg/dL

  OR

• Creatinine clearance ≥ 50 mL/min

Cardiovascular

• Ejection fraction normal by echocardiogram or nuclear medicine
• No symptomatic cardiac disease
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Pulmonary

• DLCO ≥ 55% of normal
• FEV₁ ≥ 60% of normal
• No symptomatic pulmonary disease

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception
• HIV negative
• No other concurrent uncontrolled illness
• No active or ongoing infection
• No psychiatric illness or social situation that would preclude study compliance
• No other active cancer requiring treatment
• No anti-toxin or anti-mouse immunoglobulin G antibodies as evidenced by serum neutralization of LMB-2 in tissue culture
  • Serum neutralization ≤ 75% of activity of 1 μg/mL LMB-2 allowed

Expected Enrollment

A total of 16-27 patients will be accrued for this study within 2 years.

Outcomes

Response rate and response duration

Relationship between immunogenicity, toxicity, and serum concentration
Correlation of soluble Tac-peptide levels with response

Outline

This is a multicenter study.

Patients receive LMB-2 immunotoxin IV over 30 minutes on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression, unacceptable toxicity, or neutralizing antibodies. Patients who have a documented ongoing response between courses 4 and 6 receive up to 3 additional courses.

Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Robert Kreitman, MD, Principal investigator		Ph: 301-496-6947 Email: kreitmar@mail.nih.gov

U.S.A.
Maryland
	Bethesda
	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
		Patient Recruitment	Ph:  888-NCI-1937

Related Information

Featured trial article
Web site for additional information

Registry Information
Official Title		A Phase II Clinical Trial Of Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin For Treatment Of CD25 Positive Cutaneous T-Cell Lymphomas
Trial Start Date		2004-03-16
Registered in ClinicalTrials.gov		NCT00085085
Date Submitted to PDQ		2004-04-16
Information Last Verified		2008-05-20

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