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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001705 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma Neoplasm Metastasis |
Drug: GP100 peptide Drug: IL-2 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety/Efficacy Study |
| Official Title: | Immunization of Patients With Metastatic Melanoma Using the GP100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence |
| Estimated Enrollment: | 141 |
| Study Start Date: | July 1998 |
| Estimated Study Completion Date: | June 2001 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations More Information
| Study ID Numbers: | 980142, 98-C-0142 |
| Study First Received: | November 3, 1999 |
| Last Updated: | March 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001705 History of Changes |
| Health Authority: | United States: Federal Government |
|
Antigen Cancer Immunotherapy |
|
Neuroectodermal Tumors Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Neoplasm Metastasis Nevi and Melanomas Neuroendocrine Tumors Melanoma |
