Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Refractory Metastatic Melanoma
Immunization Of HLA-A*0201 or HLA-DPB1*04 Patients With Metastatic Melanoma Using Epitopes From The ESO-1 Antigen
NCT00020397CI-TRIAL-00010817completedPhase 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: Randomized phase II trial to study the effectiveness of vaccine therapy in treating patients who have refractory metastatic melanoma.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| NY-ESO-1 peptide vaccine | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of metastatic melanoma that expresses ESO-1 antigen * Must have progressed during prior standard treatment * Measurable or evaluable disease * HLA-A\*201 or HLA-DPB1\*04 positive 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: * SGOT and SGPT less than 3 times normal * Bilirubin no greater than 1.6 mg/dL (3.0 mg/dL for patients with Gilbert's syndrome) * Hepatitis B surface antigen negative Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No cardiac ischemia\* * No myocardial infarction\* * No cardiac arrhythmias\* NOTE: \*For interleukin-2 (IL-2) administration Pulmonary: * No obstructive or restrictive pulmonary disease (for IL-2 administration) Immunologic: * No autoimmune disease * No active primary or secondary immunodeficiency * HIV negative * No active systemic infections Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No other active major medical illness (for IL-2 administration) PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior ESO-1 immunization Chemotherapy: * Recovered from any prior chemotherapy Endocrine therapy: * No concurrent systemic steroid therapy Radiotherapy: * Recovered from any prior radiotherapy Surgery: * Not specified Other: * At least 3 weeks since any prior systemic therapy for cancer * No other concurrent systemic therapy for cancer
References
Publications (1)
- RESULTKhong HT, Yang JC, Topalian SL, Sherry RM, Mavroukakis SA, White DE, Rosenberg SA. Immunization of HLA-A*0201 and/or HLA-DPbeta1*04 patients with metastatic melanoma using epitopes from the NY-ESO-1 antigen. J Immunother. 2004 Nov-Dec;27(6):472-7. doi: 10.1097/00002371-200411000-00007. PMID 15534491