Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Metastatic Melanoma
Immunization of Patients With Metastatic Melanoma Using Recombinant Fowlpox and Vaccinia Viruses Encoding the Tyrosinase Antigen
NCT00019734CI-TRIAL-00010872completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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. PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy with and without interleukin-2 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 |
| vaccinia-tyrosinase vaccine | 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 treatment * No ocular or mucosal melanoma as primary site * Measurable disease * No existing brain metastases PATIENT CHARACTERISTICS: Age: * 16 and over Performance status: * ECOG 0 or 1 Life expectancy: * More than 3 months Hematopoietic: * WBC at least 3,000/mm3 * Platelet count at least 90,000/mm3 * No coagulation disorder Hepatic: * Bilirubin no greater than 1.6 mg/dL * AST/ALT less than 3 times normal * Hepatitis B surface antigen negative Renal: * Creatinine no greater than 1.6 mg/dL Cardiovascular: * No major cardiovascular illness Pulmonary: * No major respiratory illness Immunologic: * HIV negative * No autoimmune disease * No primary or secondary immunodeficiency * No allergy to eggs * No history of allergy or untoward reaction to prior smallpox vaccination Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Must be able to avoid close contact with children under 5 years, pregnant women, people with active or a past history of eczema or other eczematoid skin disorders, and immunosuppressed people for at least 2 weeks after each vaccinia virus vaccination * No active systemic infections * No active atopic dermatitis or active or past history of eczema * No concurrent active extensive psoriasis, severe acneiform rash, impetigo, varicella zoster, burns, or other traumatic or pruritic skin conditions or open wounds * Surgical scars must be healed * Healed surgical stomas (e.g., colostomy) allowed PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior recombinant vaccinia or fowlpox vaccines for melanoma * At least 3 weeks since prior systemic biologic therapy for melanoma Chemotherapy: * At least 3 weeks since prior systemic chemotherapy for melanoma Endocrine therapy: * At least 3 weeks since prior systemic endocrine therapy for melanoma * No concurrent steroid therapy Radiotherapy: * At least 3 weeks since prior systemic radiotherapy for melanoma Surgery: * Prior surgery allowed
References
Publications (0)
Data not yet available
No reference posted for this study.