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Immunization of Patients With Metastatic Melanoma Using the GP100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence


Phase 2
N/A
N/A
Not Enrolling
Both
Melanoma, Neoplasm Metastasis

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Trial Information

Immunization of Patients With Metastatic Melanoma Using the GP100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence


Patients with metastatic melanoma who are HLA-A201+ will be immunized with a modified
peptide from the gp100 molecule that contains a signal sequence designed to improve peptide
presentation by antigen presenting cells. This peptide called gp100:ES209-217 (210M) will
be administered either alone or in combination with high or low dose IL-2. Patients will be
evaluated for clinical response, as well as undergo studies of the immunologic response to
the peptide immunization.

Inclusion Criteria


Any patient age greater than or equal to 18 with measurable metastatic melanoma who has
failed standard treatment and has an expected survival of greater than three months will
be considered.

Serum creatinine of 2.0 mg/dl or less.

Bilirubin 1.6 mg/dl or less.

WBC 3000/mm(3) or greater.

Platelet count 90,000 mm(3) or greater.

Serum AST/ALT less then two times normal.

ECOG performance status of 0 or 1 or 2.

Patients of both genders must be willing to practice effective birth control during this
trial.

No patients who are undergoing or have undergone in the past 3 weeks any other form of
therapy except surgery for their cancer.

No patients who have active systemic infections, coagulation disorders, autoimmune disease
or other major medical illnesses of the cardiovascular or respiratory systems or any known
immunodeficiency disease. Patients with cardiovascular disease will be eligible to
receive peptide in IFA alone.

No patients who require steroid therapy.

No patients who are pregnant (because of possible side effects on the fetus).

No patients who are known to be positive for hepatitis BsAG or HIV antibody (because of
possible immune effects of these conditions).

No patients who have any form of primary or secondary immunodeficiency. (The experimental
treatment being evaluated in this protocol depends on an intact immune system. Patients
who have decreased immune competence may be less responsive to the experimental treatment
and more susceptible to its toxicities).

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

980142

NCT ID:

NCT00001705

Start Date:

July 1998

Completion Date:

June 2001

Related Keywords:

  • Melanoma
  • Neoplasm Metastasis
  • Antigen
  • Cancer
  • Immunotherapy
  • Neoplasms
  • Melanoma
  • Neoplasm Metastasis

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892