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Randomized Comparison of Peptide Immunization in Patients at High Risk for Recurrence of Melanoma

Phase 2
7 Years
Not Enrolling

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Trial Information

Randomized Comparison of Peptide Immunization in Patients at High Risk for Recurrence of Melanoma

Human leukocyte antigens (HLA-A)*0201 positive patients at high risk for recurrence of
melanoma, or completely resected metastatic melanoma will receive immunization with peptides
representing human leukocyte antigen (HLA)-restricted T cell epitopes of the melanoma
antigen recognized by T-cells (MART-1) or glycoprotein 100 (gp100) melanoma antigens
emulsified in Montanide ISA-51 or Montanide trademark(TM) ISA 51 vegetable grade (VG).
Patients will be randomized to receive one of three different melanoma antigen recognized by
T-cells (MART-1) peptides or to receive a combination of a melanoma antigen recognized by
T-cells (MART-1) peptide plus a glycoprotein 100 (gp100) peptide. This study is designed to
evaluate the immunologic effects of the different peptide immunizations.

Inclusion Criteria


Human leukocyte antigens (HLA-A)*0201 patients, age greater than or equal to 16 years,
with lesions greater than or equal to 1.5 mm in thickness, or greater than or equal to 1
positive lymph node, or ulcerated lesions, or local recurrence, or completely resected
metastatic melanoma, within 6 months of surgical resection will be considered. Patients
must be clinically disease free at the time of protocol entry as documented by radiologic
studies within 6 weeks of patient entry.

Serum creatinine of 2.0 mg/dl or less.

Total bilirubin 1.6 mg/dl or less, except for patients with Gilbert's Syndrome who must
have a total bilirubin less than 3.0 mg/dl.

White blood cell (WBC) 3000/mm^3 or greater.

Platelet count 90,000 mm^3 or greater.

Serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than three
times normal.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Patients of both genders must be willing to practice effective birth control during this
trial because the potential for teratogenic effects are unknown.

Patients may have had prior adjuvant treatment with immunotherapy, including interferon,
or may have had treatment for metastatic disease and are now no evidence of disease (NED),
including chemotherapy or biotherapy, as long as 3 weeks have elapsed since prior systemic


Patients will be excluded:

1. who have ocular or mucosal melanoma.

2. who are undergoing or have undergone in the past 3 weeks any systemic therapy except
surgery for their cancer, and must have recovered from any adverse effects of
treatment prior to entry, other than those that do not have clinical implications,
e.g. vitiligo, alopecia.

3. have active systemic infections, autoimmune disease or any known immunodeficiency

4. who require systemic steroid therapy.

5. who are pregnant or breastfeeding.

6. who are known to be positive for hepatitis B surface antigen (B(s)AG) or human
immunodeficiency virus (HIV) antibody.

7. who have any form of active primary or secondary immunodeficiency or who have not
recovered immune competence after chemotherapy or radiation therapy.

8. who have previously been immunized with melanoma antigen recognized by T-cells

9. who have known hypersensitivity to any of the agents used in this study.


Patients who develop progressive disease while receiving peptide alone must meet the
following criteria to be eligible to receive Interleukin-2 (IL-2):

1. Patients must have measurable metastatic melanoma.

2. Patients may not have active major medical illnesses such as cardiac ischemia,
myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary

3. Patients with recent prolonged history of cigarette smoking or symptoms of
respiratory dysfunction must have a normal pulmonary function test as evidenced by a
forced expiratory volume 1 (FEV 1) greater than 60% predicted.

4. Patients with electrocardiogam (EKG) abnormalities, symptoms of cardiac ischemia or
arrhythmias or age greater than 50 years will have a normal stress cardiac test
(stress thallium, stress multi-gated acquisition scan (MUGA), dobutamine
echocardiogram or other stress test).

5. Patients must be willing to sign a durable power of attorney (DPA).

6. Serum creatinine of 2.0 mg/dl or less.

7. Total bilirubin 2.0 mg/dl or less, except in patients with Gilbert's Syndrome who
must have a total bilirubin less than 3.0 mg/dl.

8. White blood cell (WBC) 3000/mm^3 or greater.

9. Platelet count 90,000 mm^3 or greater.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Immunologic Response Rate

Outcome Description:

Immunologic monitoring will be conducted using in vitro sensitization assays. The immunologic response in these assays will be considered positive if at least a two-fold increase in vaccine specific interferon gamma (y-IFN) secretion is seen between post vaccination specimens compared to the pre vaccination specimens.

Outcome Time Frame:

11 months

Safety Issue:


Principal Investigator

Steven A Rosenberg, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute, National Institutes of Health


United States: Federal Government

Study ID:




Start Date:

April 2003

Completion Date:

May 2010

Related Keywords:

  • Melanoma
  • Adjuvant Therapy
  • MART-1 Peptides
  • GP100 Peptide
  • Immunologic Response
  • Melanoma
  • Melanoma



National Cancer Institute (NCI) Bethesda, Maryland  20892