Clinical trial · Interventional
Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma
A Phase II Trial of a MART-1/gp100/Tyrosinase Peptide-Pulsed Dendritic Cell Vaccine Treated With CD40 Ligand/Gamma Interferon With Subcutaneous IL-2 for Patients With Metastatic Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of efficacy
Summary
Brief summary (as posted)
RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to kill tumor cells. Biological therapies such as interferon gamma and interleukin-2 use different ways to stimulate the immune system and stop cancer cells from growing. Combining vaccine therapy with biological therapy may kill more tumor cells. PURPOSE: This phase II trial is studying giving vaccine therapy together with interferon gamma and interleukin-2 in treating patients with stage III or stage IV 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 (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| Candida albicans skin test reagent | Radiation | — | UNRESOLVED |
| gp100 antigen | Biological | — | UNRESOLVED |
| MART-1 antigen | Biological | — | UNRESOLVED |
| recombinant CD40-ligand | Biological | — | UNRESOLVED |
| recombinant interferon gamma | Biological | — | UNRESOLVED |
| recombinant interleukin-4 | Biological | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic melanoma * Measurable disease after attempted curative surgery * Unresectable stage III or IV uveal melanoma * Metastatic mucosal melanoma * HLA-A2.1 positive * No disease progression following high dose interleukin-2 (600,000 or 720,000 IU/kg every 8 hours) PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 75,000/mm\^3 * Hemoglobin at least 9.0 g/dL * No coagulation disorders Hepatic: * Bilirubin no greater than 2.0 mg/dL Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No myocardial infarction within the past 6 months * Patients with documented or suspected coronary artery disease must undergo stress thallium test * No major cardiovascular illness Pulmonary: * No major pulmonary illness Immunologic: * HIV negative * Hepatitis B surface antigen negative * Hepatitis C antibody negative * No history of uveitis or autoimmune inflammatory eye disease Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No major systemic infection * No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * No prior MART-1:26-35, gp100:209-217, or tyrosinase:368-376 antigens Chemotherapy: * At least 1 month since prior chemotherapy for melanoma Endocrine therapy: * No concurrent steroid therapy Radiotherapy: * At least 1 month since prior radiotherapy for melanoma Surgery: * See Disease Characteristics Other: * At least 1 month since prior adjuvant therapy for melanoma * At least 1 month since other prior therapy for melanoma
References
Publications (0)
Data not yet available