Clinical trial · Interventional
Azacitidine and Interferon Alfa in Treating Patients With Metastatic Melanoma
A Phase I Study of 5-azacytidine (Vidaza) With Interferon α2b in Metastatic Melanoma Patients
- 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: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Interferon alfa may interfere with the growth of tumor cells. Giving azacitidine together with interferon alfa may be an effective treatment for melanoma. PURPOSE: This phase I trial is studying the side effects and best dose of azacitidine when given together with interferon alfa 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 |
|---|---|---|---|
| azacitidine | Drug | Azacitidine | ALIAS |
| recombinant interferon alfa-2b | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Maximum tolerated dose
- measure
- Toxicity
Secondary outcomes (4)
- measure
- Response
- measure
- Survival at day 1, 12 months, 3 years, and 5 years
- measure
- Relapse-free survival
- measure
- Time to relapse
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic melanoma * At least one lesion appropriate for 3 separate punch or core needle biopsies * Must have received and failed ≥ 1 prior systemic treatment for metastatic disease PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT \< 2 times ULN * Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 60 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known allergies to azacitidine, interferon alfa, benzyl alcohol, or mannitol * No uncontrolled infection * No known HIV positivity * No hepatitis B or hepatitis C infection PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 3 weeks since prior systemic therapy * More than 4 weeks since prior radiotherapy to target lesions with evidence of progression * No concurrent radiotherapy to target lesions * No concurrent oral or IV corticosteroids * Topical creams or ocular steroid drops are allowed
References
Publications (0)
Data not yet available