Clinical trial · Interventional
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma
Immunization of Patients With Metastatic Melanoma Using a Recombinant Fowlpox Virus Encoding a GP100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence
- 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. It is not yet known whether combining melanoma vaccine with interleukin-2 is more effective than vaccine therapy alone in treating metastatic melanoma. PURPOSE: Phase II trial to compare the effectiveness of melanoma vaccine and interleukin-2 with that of melanoma vaccine 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 |
| fowlpox virus vaccine vector | Biological | — | UNRESOLVED |
| gp100 antigen | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven metastatic melanoma that has failed standard treatment * Measurable disease * HLA-A-201 positive PATIENT CHARACTERISTICS: Age: * 16 and over Performance status: * ECOG 0-2 Life expectancy: * More than 3 months Hematopoietic: * WBC ≥ 3,000/mm\^3 * Platelet count ≥ 90,000/mm\^3 * No coagulation disorders Hepatic: * Bilirubin ≤ 1.6 mg/dL (less than 3.0 mg/dL for patients with Gilbert's syndrome) * AST/ALT \< 2 times normal * Hepatitis B surface antigen negative Renal: * Creatinine ≤ 2.0 mg/dL Cardiovascular: * No major cardiovascular disease * No cardiac ischemia by a stress thallium test or other comparable test\* * No myocardial infarction\* * No cardiac arrhythmias\* NOTE: \*In order to be eligible to receive interleukin-2 (IL-2) Pulmonary: * No major respiratory disease * No obstructive or restrictive pulmonary disease\* NOTE: \*In order to be eligible to receive IL-2 Immunologic: * No autoimmune disease * No known immunodeficiency disease * No primary or secondary immunodeficiency * No allergy to eggs * No active systemic infections * HIV negative Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No other active major medical illness\* NOTE: \*In order to be eligible to receive IL-2 PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior gp100 vaccination Chemotherapy: * Not specified Endocrine therapy: * No concurrent steroids Radiotherapy: * Not specified Surgery: * Prior surgery for the malignancy allowed Other: * At least 3 weeks since other prior therapy for the malignancy
References
Publications (1)
- BACKGROUNDRosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Topalian SL, Sherry RM, Restifo NP, Wunderlich JR, Seipp CA, Rogers-Freezer L, Morton KE, Mavroukakis SA, Gritz L, Panicali DL, White DE. Recombinant fowlpox viruses encoding the anchor-modified gp100 melanoma antigen can generate antitumor immune responses in patients with metastatic melanoma. Clin Cancer Res. 2003 Aug 1;9(8):2973-80. PMID 12912944