Clinical trial · Interventional
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma
Immunization of Patients With Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201
- 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. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may be an effective treatment for metastatic melanoma. PURPOSE: Phase II trial to compare the effectiveness of vaccine therapy with or without interleukin-2 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 confirmed metastatic melanoma that has failed standard therapy * Measurable disease * HLA-A0201 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: * Bilirubin no greater than 2.0 mg/dL (less than 3.0 mg/dL for patients with Gilbert's syndrome) * AST/ALT less than 3 times normal * Hepatitis B surface antigen negative * No coagulation disorder Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No major cardiovascular disease * If cardiovascular disease or other debilitating symptoms present, may receive peptide emulsified with Montanide ISA-51 only Pulmonary: * No major respiratory disease Other: * Not pregnant * Fertile patients must use effective contraception * HIV negative * No active systemic infection * No autoimmune disease or immunodeficiency disease * No primary or secondary immunodeficiency PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 3 weeks since prior biologic therapy * No prior MART-1 antigen immunization 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 allowed
References
Publications (0)
Data not yet available