Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Metastatic Melanoma
Immunization of Patients With Metastatic Melanoma Using a Class II Restricted Peptide From the GP100 Antigen and Class I Restricted Peptides From the GP100 and MART-1 Antigens
NCT00019994CI-TRIAL-00010786completedPhase 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)
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma that has not responded to previous therapy.
Conditions
Conditions (1)
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 (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| gp100 antigen | Biological | — | UNRESOLVED |
| incomplete Freund's adjuvant | Biological | — | UNRESOLVED |
| MART-1 antigen | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven metastatic melanoma that has failed standard treatment * HLA-DRB1\*0401 positive * Known HLA-A0201 status PATIENT CHARACTERISTICS: Age: * 16 and over Performance status: * ECOG 0-2 Life expectancy: * More than 3 months Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 90,000/mm\^3 Hepatic: * Bilirubin no greater than 2.0 mg/dL * AST or ALT less than 3 times normal * Hepatitis B surface antigen negative Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No symptomatic cardiac disease Immunologic: * No autoimmune disease * No primary or secondary immunodeficiency disease * HIV negative Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active systemic infection PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunization to the entire gp100 molecule * At least 3 weeks since prior gp100:209-217 antigen peptide * At least 3 weeks since other prior biologic therapy Chemotherapy: * At least 3 weeks since prior chemotherapy Endocrine therapy: * At least 3 weeks since prior endocrine therapy * No concurrent steroid therapy Radiotherapy: * At least 3 weeks since prior radiotherapy Surgery: * Prior surgery for cancer allowed Other: * At least 3 weeks since any prior therapy except surgery for cancer
References
Publications (1)
- BACKGROUNDPhan GQ, Touloukian CE, Yang JC, Restifo NP, Sherry RM, Hwu P, Topalian SL, Schwartzentruber DJ, Seipp CA, Freezer LJ, Morton KE, Mavroukakis SA, White DE, Rosenberg SA. Immunization of patients with metastatic melanoma using both class I- and class II-restricted peptides from melanoma-associated antigens. J Immunother. 2003 Jul-Aug;26(4):349-56. doi: 10.1097/00002371-200307000-00007. PMID 12843797