LMB-2 Immunotoxin and Vaccine Therapy in Treating Patients With Metastatic Melanoma That Cannot Be Removed By Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00295958
Recruitment Status : Completed
First Posted : February 24, 2006
Last Update Posted : June 14, 2012
National Cancer Institute (NCI)
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief Summary:

RATIONALE: The LMB-2 immunotoxin can find tumor cells and kill them without harming normal cells. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving LMB-2 immunotoxin together with vaccine therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving LMB-2 immunotoxin together with vaccine therapy works in treating patients with metastatic melanoma that cannot be removed by surgery.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Non-melanomatous Skin Cancer Biological: LMB-2 immunotoxin Biological: MART-1 antigen Biological: gp100 antigen Biological: incomplete Freund's adjuvant Phase 2

Detailed Description:



  • Determine objective clinical response in patients with progressive, unresectable metastatic melanoma treated with recombinant LMB-2 immunotoxin and peptide vaccination comprising gp100:209-217 (210M) antigen, MART-1:27-35 antigen, and Montanide ISA-51.


  • Determine changes in levels of CD4+, CD25+ regulatory T cells in peripheral blood before and after treatment in patients treated with this regimen.
  • Determine the ability of recombinant immunotoxin LMB-2 to augment peptide vaccination in these patients.
  • Determine the toxicity profile of this regimen in these patients.

OUTLINE: Patients receive LMB-2 immunotoxin IV over 30 minutes twice on days 1-3. Patients then receive peptide vaccinations comprising gp100:209-217 (210M) antigen emulsified in Montanide ISA-51 subcutaneously (SC), and MART-1:27-35 vaccine emulsified in Montanide ISA-51 SC on days 4, 5, 6, and 24-27 (course 1). After week 8, patients achieving tumor response may receive 1 additional course in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically in the absence of disease progression.

PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Evaluation of Peptide Immunization and LMB-2 in Metastatic Melanoma
Study Start Date : December 2005
Actual Primary Completion Date : June 2006
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Primary Outcome Measures :
  1. Objective clinical response rate

Secondary Outcome Measures :
  1. Changes in levels of CD4+, CD25+ regulatory T cells
  2. Ability of LMB-2 to augment peptide vaccination
  3. Toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of metastatic melanoma

    • Unresectable disease
    • Progressive disease while receiving standard therapy (e.g., interleukin-2 or dacarbazine)
  • HLA-A0201 positive
  • Measurable disease
  • The following are not allowed:

    • Resectable local/regional disease
    • Patients whose serum neutralizes LMB-2 in tissue culture, due either to antitoxin or antimouse-immunoglobulin G antibodies (> 75% of the activity of 1 ug/mL of LMB-2)
    • Received LMB-2 on another trial


  • ECOG performance status 0-2
  • Life expectancy more than 3 months
  • WBC ≥ 3,000/mm^3
  • Absolute lymphocyte count > 500/mm^3
  • Platelet count ≥ 90,000/mm^3
  • Bilirubin ≤ 2.0 mg/dL (≤ 3.0 mg/dL for patients with Gilbert's syndrome)
  • AST and ALT ≤ 2.5 times normal
  • Albumin ≥ 3.0 g/dL
  • No hepatitis B surface antigen or hepatitis C positivity
  • Creatinine ≤ 1.4 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No ongoing or active infection
  • Ejection fraction ≥ 45% by echocardiogram or thallium stress test (for patients > 50 years of age OR who have a history of cardiovascular disease)
  • LVEF ≥ 45%
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness
  • No known HIV positivity
  • No autoimmune disease
  • No immunodeficiency
  • No other malignancies
  • Must be willing to undergo leukapheresis


  • See Disease Characteristics
  • More than 12 weeks since prior monoclonal antibody therapy
  • More than 3 weeks since prior and no concurrent systemic therapy for cancer
  • No concurrent chronic anticoagulant therapy
  • No concurrent systemic steroid therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00295958

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
NCI - Surgery Branch
Bethesda, Maryland, United States, 20892-1201
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
Study Chair: Steven A. Rosenberg, MD, PhD NCI - Surgery Branch

Responsible Party: Steven A. Rosenberg, M.D./National Cancer Institute, National Institutes of Health Identifier: NCT00295958     History of Changes
Obsolete Identifiers: NCT00263510
Other Study ID Numbers: 060041
First Posted: February 24, 2006    Key Record Dates
Last Update Posted: June 14, 2012
Last Verified: June 2012

Keywords provided by National Institutes of Health Clinical Center (CC):
recurrent melanoma
stage IV melanoma
skin cancer

Additional relevant MeSH terms:
Skin Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Skin Diseases
Freund's Adjuvant
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic