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Phase II Evaluation of Peptide Immunization and LMB-2 in Metastatic Melanoma

Phase 2
18 Years
Not Enrolling
Melanoma (Skin), Non-melanomatous Skin Cancer

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Trial Information

Phase II Evaluation of Peptide Immunization and LMB-2 in Metastatic Melanoma



- 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.

Inclusion Criteria


- Diagnosis of metastatic melanoma

- Unresectable disease

- Progressive disease while receiving standard therapy (e.g., interleukin-2 or

- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective clinical response rate

Safety Issue:


Principal Investigator

Steven A. Rosenberg, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Surgery Branch


United States: Food and Drug Administration

Study ID:




Start Date:

December 2005

Completion Date:

July 2008

Related Keywords:

  • Melanoma (Skin)
  • Non-melanomatous Skin Cancer
  • recurrent melanoma
  • stage IV melanoma
  • skin cancer
  • Skin Neoplasms
  • Melanoma



Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral OfficeBethesda, Maryland  20892-1182
NCI - Surgery BranchBethesda, Maryland  20892-1201