Clinical trial · Interventional
Interferon Alfa With or Without Vaccine Therapy in Treating Patients With Metastatic Melanoma
PHASE III TRIAL OF MELACINE PLUS INTERFERON ALFA-2B VERSUS INTERFERON ALFA-2B IN PATIENTS WITH DISSEMINATED MALIGNANT MELANOMA
- 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: Interferon alfa may interfere with the growth of cancer cells.Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether melanoma vaccine plus interferon alfa is more effective than interferon alfa alone in treating patients with metastatic melanoma. PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without vaccine therapy in treating patients with 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Detox-B adjuvant | Biological | — | UNRESOLVED |
| recombinant interferon alfa | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically confirmed malignant melanoma that is metastatic (any pT, any N, M1 by AJCC staging) Measurable disease by physical exam or noninvasive radiologic procedure No concurrent or prior diagnosis of ocular melanoma No CNS metastases No patients who can be rendered NED by surgery unless patient declines surgery PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Life expectancy: At least 4 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 mg/dL AST or ALT no greater than 3 times normal No evidence of hepatic failure No active hepatitis Renal: Creatinine clearance at least 40 mL/min Cardiovascular: No myocardial infarction within 6 months No decompensating congestive heart failure No unstable angina No current symptomatic arrhythmia Other: No known HIV antibody No thyroid abnormality uncontrollable by medication No medical, sociological, or psychological impediment to study compliance No pre-existing psychiatric condition (especially depression) or history of severe psychiatric disorder No autoimmune disease (e.g., systemic lupus erythematosus, multiple sclerosis, ankylosing spondylitis) No concurrent malignancy except nonmelanomatous skin cancer Not pregnant or nursing Negative pregnancy test Effective contraception required of fertile women No history of egg allergies PRIOR CONCURRENT THERAPY: Biologic therapy: At least 12 months since interferon alfa or melanoma vaccine No prior immunotherapy for metastatic disease No concurrent cytokines or levamisole Chemotherapy: No prior chemotherapy for metastatic disease At least 4 months since adjuvant therapy No concurrent chemotherapy Endocrine therapy: At least 1 week since corticosteroids No concurrent immunosuppressives (e.g., azathioprine or cyclosporine) Radiotherapy: Prior radiotherapy for metastatic disease allowed Surgery: See Disease Characteristics Prior surgery for metastatic disease allowed
References
Publications (0)
Data not yet available