Clinical trial · Interventional
Vaccine Therapy and Interleukin-2 in Treating Patients With Metastatic Melanoma
Treatment Of Patients With Metastatic Melanoma Using Recombinant Vaccinia And Fowlpox Viruses Encoding The Tyrosine Antigen In Combination With Interleukin-2
NCT00054535CI-TRIAL-00010836completedPhase 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 that will kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with interleukin-2 in treating patients who have metastatic 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| recombinant fowlpox-tyrosinase vaccine | Biological | — | UNRESOLVED |
| vaccinia-tyrosinase vaccine | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of metastatic melanoma * Measurable disease * Disease progression while receiving prior standard treatment * No ocular or mucosal primary site * No uncontrolled brain metastases PATIENT CHARACTERISTICS: Age * 16 and over Performance status * ECOG 0-1 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 1.6 mg/dL (less than 3.0 mg/dL in patients with Gilbert's syndrome) * AST/ALT less than 3 times normal * Hepatitis B surface antigen negative * Hepatitis C antibody 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 active systemic infections * No primary or secondary immunodeficiency (e.g., hereditary disorders such as ataxia-telangiectasia or Wiskott-Aldrich syndrome or acquired immunodeficiencies after bone marrow transplantation) * No allergy to eggs * No prior allergy or untoward reaction to smallpox vaccination (if previously vaccinated) Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No close contact with the following individuals for 2 weeks after vaccinia vaccination: * Children under 5 years of age * Pregnant women * Individuals with prior or active eczema or other eczematoid skin disorders * Individuals with other acute, chronic, or exfoliative skin conditions (e.g., burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds) * Immunosuppressed individuals * No active atopic dermatitis * No prior or active eczema * No active cases of the following conditions: * Extensive psoriasis * Severe acneiform rash * Impetigo * Varicella zoster * Burns * Traumatic or pruritic skin conditions * Open wounds * No unhealed surgical scars * Healed surgical stomas (e.g., colostomy) allowed PRIOR CONCURRENT THERAPY: Biologic therapy * No prior recombinant vaccinia or fowlpox vaccines for melanoma * No prior vaccination with full length tyrosinase protein, or a vector encoding the full length protein for melanoma * Prior individual tyrosinase peptides are allowed * No prior high-dose interleukin-2 Chemotherapy * Not specified Endocrine therapy * No concurrent oral, IV, topical, or inhaled steroids Radiotherapy * Not specified Surgery * Recovered from prior surgery Other * Recovered from prior therapy for melanoma * More than 3 weeks since prior systemic therapy for melanoma * No other concurrent systemic therapy for melanoma
References
Publications (0)
Data not yet available
No reference posted for this study.