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LMB-2 Immunotoxin in Treating Patients With Cutaneous T-Cell Lymphoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), May 2008
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00085085
  Purpose

RATIONALE: LMB-2 immunotoxin can locate cancer cells and kill them without harming normal cells.

PURPOSE: This phase II trial is studying how well LMB-2 immunotoxin works in treating patients with cutaneous T-cell lymphoma.


Condition Intervention Phase
Lymphoma
Drug: LMB-2 immunotoxin
Phase II

MedlinePlus related topics: Cancer Fungal Infections Lymphoma
Drug Information available for: Dacliximab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Clinical Trial Of Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin For Treatment Of CD25 Positive Cutaneous T-Cell Lymphomas

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate and response duration [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relationship between immunogenicity, toxicity, and serum concentration [ Designated as safety issue: Yes ]
  • Correlation of soluble Tac-peptide levels with response [ Designated as safety issue: No ]

Estimated Enrollment: 27
Study Start Date: March 2004
Detailed Description:

OBJECTIVES:

Primary

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

Secondary

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

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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,000/mm^3 (500/mm^3 if blood or bone marrow involvement)
  • Platelet count ≥ 50,000/mm^3 (10,000/mm^3 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
  • FEV_1 ≥ 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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00085085

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Patient Recruitment     888-NCI-1937        
Sponsors and Collaborators
Investigators
Principal Investigator: Robert Kreitman, MD National Cancer Institute (NCI)
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
Featured trial article  This link exits the ClinicalTrials.gov site
Web site for additional information  This link exits the ClinicalTrials.gov site

Publications indexed to this study:
Study ID Numbers: CDR0000367248, NCI-04-C-0142, NCI-5943
Study First Received: June 10, 2004
Last Updated: December 11, 2008
ClinicalTrials.gov Identifier: NCT00085085  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent cutaneous T-cell non-Hodgkin lymphoma
stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent mycosis fungoides/Sezary syndrome
stage I mycosis fungoides/Sezary syndrome
stage II mycosis fungoides/Sezary syndrome
stage III mycosis fungoides/Sezary syndrome
stage IV mycosis fungoides/Sezary syndrome

Study placed in the following topic categories:
Sezary syndrome
Immunoproliferative Disorders
Daclizumab
Cutaneous T-cell lymphoma
Lymphoma, small cleaved-cell, diffuse
Sezary Syndrome
Mycosis Fungoides
Immunotoxins
Recurrence
Antibodies, Monoclonal
Mycoses
Lymphatic Diseases
Antibodies
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Immunoglobulins
Lymphoma, T-Cell, Cutaneous

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009