Clinical trial · Interventional
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma That Has Not Responded to Previous Treatment
Immunization of HLA-0201 Positive Patients With Metastatic Melanoma Using a Peptide From Tyrosinase-related Protein 2 (TRP-2)
- 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: Randomized phase II trial to compare the effectiveness of vaccine therapy plus interleukin-2 to that of vaccine therapy alone in treating patients who have metastatic melanoma that has not responded to previous treatment.
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 |
| incomplete Freund's adjuvant | Biological | — | UNRESOLVED |
| recombinant tyrosinase-related protein-2 | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of metastatic melanoma * Refractory to standard therapy * No resectable locoregional disease * HLA-A0201 positive * Measurable disease * Previously resected brain metastases, brain metastases stable after prior radiosurgery, or brain metastases less than 1 cm and without edema allowed 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 * No coagulation disorders Hepatic: * Bilirubin no greater than 2.0 mg/dL (3.0 mg/dL for patients with Gilbert's syndrome) * AST/ALT less than 3 times normal * Hepatitis B surface antigen negative Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No major medical illness of the cardiovascular system * No cardiac ischemia\* * No myocardial infarction\* * No cardiac arrhythmias\* NOTE: \* For interleukin-2 (IL-2) administration Pulmonary: * No major medical illness of the respiratory system * No obstructive or restrictive pulmonary disease (for IL-2 administration) Immunologic: * HIV negative * No primary or secondary immunodeficiency * No known immunodeficiency disease * No autoimmune disease * No active systemic infections Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 3 weeks since prior biologic therapy for melanoma * No prior immunization to tyrosinase-related protein-2 antigen * No other concurrent biologic therapy for melanoma Chemotherapy: * At least 3 weeks since prior chemotherapy for melanoma and recovered * No concurrent chemotherapy for melanoma Endocrine therapy: * At least 3 weeks since prior endocrine therapy for melanoma * No concurrent systemic steroid therapy * No concurrent endocrine therapy for melanoma Radiotherapy: * See Disease Characteristics * At least 3 weeks since prior radiotherapy for melanoma and recovered * No concurrent radiotherapy for melanoma Surgery: * See Disease Characteristics Other: * No other concurrent therapy for melanoma
References
Publications (0)
Data not yet available