Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Recurrent or Refractory Metastatic Melanoma
Immunization of Patients With Metastatic Melanoma Using Immunodominant Peptides From the Tyrosinase Protein or Tyrosinase Related Protein-1 (TRP1)
NCT00019383CI-TRIAL-00010892completedPhase 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. Giving the vaccine with interleukin-2 or sargramostim may help kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of peptide vaccine with or without adjuvant interleukin-2 or sargramostim in treating patients who have recurrent or 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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| incomplete Freund's adjuvant | Biological | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
| tyrosinase peptide | Biological | — | UNRESOLVED |
| tyrosinase-related protein-1 | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven refractory metastatic melanoma * Must be HLA-A1, HLA-A3, HLA-A24, or HLA-A31 positive * Measurable disease PATIENT CHARACTERISTICS: Age: * 16 and over Performance Status: * ECOG 0-1 Life Expectancy: * Greater than 3 months Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 90,000/mm\^3 * No coagulation disorder Hepatic: * AST or ALT less than 2 times upper limit of normal * Bilirubin no greater than 1.6 mg/dL Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No major cardiovascular disease Pulmonary: * No major respiratory disease Other: * Not pregnant * Fertile patients must use effective contraception * HIV negative * Hepatitis B surface antigen negative * No known allergy to Montanide ISA-51 * No active systemic infection * No immunodeficiency disease PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 3 weeks since prior biologic therapy * No concurrent biologic therapy Chemotherapy: * At least 3 weeks since prior chemotherapy * No concurrent chemotherapy Endocrine therapy: * At least 3 weeks since prior endocrine therapy * No concurrent steroid therapy or other endocrine therapy Radiotherapy: * At least 3 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * Prior or concurrent surgery for melanoma allowed
References
Publications (0)
Data not yet available
No reference posted for this study.