Clinical trial · Interventional
Immunization With gp100 Protein Vaccine in Treating Patients With Metastatic Melanoma
Immunization Of Patients With Metastatic Melanoma Using A Recombinant GP100 Protein (184V) And A Class I Restricted Peptide From The GP100 Antigen
NCT00072085CI-TRIAL-00010814completedPhase 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: This randomized phase II trial is studying immunization using two different gp100 protein vaccines to compare how well they work in treating patients with 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| gp100 antigen | Biological | — | UNRESOLVED |
| incomplete Freund's adjuvant | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of metastatic melanoma * Measurable disease * Progressive disease during or after prior standard treatment with or without interleukin-2 PATIENT CHARACTERISTICS: Age * 16 and over Performance status * ECOG 0-2 Life expectancy * More than 6 months Hematopoietic * WBC at least 3,000/mm\^3 * Platelet count at least 90,000/mm\^3 * Lymphocyte count greater than 500/mm\^3 Hepatic * Bilirubin no greater than 2.0 mg/dL (less than 3.0 mg/dL for patients with Gilbert's syndrome) * ALT and AST 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 active systemic infection * No autoimmune disease * No known immunodeficiency disease * No known hypersensitivity to study agents * No form of primary or secondary immunodeficiency * No opportunistic infection * HIV negative Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * No prior gp100 peptide vaccine Chemotherapy * More than 6 weeks since prior nitrosoureas Endocrine therapy * No concurrent systemic steroid therapy Radiotherapy * Not specified Surgery * Prior recent (within the past 3 weeks) minor surgical procedures allowed Other * Recovered from prior therapy (toxicity no greater than grade 1) * More than 3 weeks since prior systemic anticancer therapy * No other concurrent systemic anticancer therapy
References
Publications (0)
Data not yet available
No reference posted for this study.