Clinical trial · Interventional
Immunization of Patients With Metastatic Melanoma Using the GP100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence
NCT00001705CI-TRIAL-00001305completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GP100 peptide | Drug | — | UNRESOLVED |
| IL-2 | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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).
References
Publications (3)
- BACKGROUNDRosenberg SA, Yang JC, Topalian SL, Schwartzentruber DJ, Weber JS, Parkinson DR, Seipp CA, Einhorn JH, White DE. Treatment of 283 consecutive patients with metastatic melanoma or renal cell cancer using high-dose bolus interleukin 2. JAMA. 1994 Mar 23-30;271(12):907-13. PMID 8120958
- BACKGROUNDRosenberg SA. Cancer vaccines based on the identification of genes encoding cancer regression antigens. Immunol Today. 1997 Apr;18(4):175-82. doi: 10.1016/s0167-5699(97)84664-6. No abstract available. PMID 9136454
- BACKGROUNDRosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL, Restifo NP, Dudley ME, Schwarz SL, Spiess PJ, Wunderlich JR, Parkhurst MR, Kawakami Y, Seipp CA, Einhorn JH, White DE. Immunologic and therapeutic evaluation of a synthetic peptide vaccine for the treatment of patients with metastatic melanoma. Nat Med. 1998 Mar;4(3):321-7. doi: 10.1038/nm0398-321. PMID 9500606