Clinical trial · Interventional
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma
Phase I/II Study in Patients With Metastatic Melanoma of Immunization With Dendritic Cells Presenting Epitopes Derived From The Melanoma Associated Antigens MART-1 and gp 100
- 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 made from white blood cells treated with antigens may make the body build an immune response to kill melanoma cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may kill more melanoma cells. PURPOSE: This phase I/II trial is studying the side effects and how well giving vaccine therapy and interleukin-2 works compared to vaccine therapy alone in treating patients with 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| gp100 antigen | Biological | — | UNRESOLVED |
| MART-1 antigen | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic melanoma that has failed standard effective therapy * Measurable or evaluable disease * HLA-A2 positive PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * More than 3 months Hematopoietic: * WBC greater than 3,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 8.0 g/dL Hepatic: * Bilirubin no greater than 2.0 mg/dL * AST/ALT less than 4 times upper limit of normal * Negative hepatitis B surface antigen * No coagulation disorder Renal: * Creatinine no greater than 1.6 mg/dL OR * Creatinine clearance greater than 75 mL/min Cardiovascular: * No major cardiovascular disease Pulmonary: * No major respiratory disease Other: * No major immunological disease * No penicillin allergy * HIV negative * No active systemic infection * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * At least 4 weeks since prior steroid therapy and recovered Radiotherapy * Not specified Surgery * Not specified Other * More than 4 weeks since any other prior therapy and recovered
References
Publications (0)
Data not yet available