Clinical trial · Observational
Effect of Proactive Management of Side Effects on Treatment Compliance in Malignant Melanoma Patients on High-dose Intron A Therapy (Study P04600)
Guidelines to the Intron A® Health Management Program II: A Nursing Support Program for Patients With High-Risk Melanoma Receiving High Dose Intron A Therapy
NCT00723710CI-TRIAL-00018938completedResults postedClinicalTrials.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)
Patients with malignant melanoma who had undergone surgery will receive adjuvant treatment with high-dose Intron A for one year. The objective of this study is to maximize treatment compliance by proactive management of side effects in a day-to-day healthcare setting.
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 | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intron A (interferon alfa-2b; SCH 30500) | Biological | Interferon Alfa-2b | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Intron A
- description
- Patients with malignant melanoma who are free of disease post-surgery but at high risk for systemic recurrence.
- interventionNames
- Biological: Intron A (interferon alfa-2b; SCH 30500)
Primary outcomes (1)
- measure
- Number of Participants Who Completed Treatment
- timeFrame
- Up to 1 year
- description
- Treatment completion was defined as those who completed both the induction and maintenance phases.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent * Age \> 18 years * Confirmed melanoma * Patient has been prescribed Intron A therapy for High-Risk Stage II \& III Melanoma * Intron A therapy started within 70 days of surgery (additional 15 days may be granted by the sponsor upon written approval) * Proper contraception in both male and female subjects and the female partner(s) of male study subjects Exclusion Criteria: * Metastatic disease at the time of diagnosis * Other malignancies * History of non compliance to other therapies * Pregnancy or breast feeding * Previous Intron A therapy
References
Publications (1)
- RESULTLevesque N, Mitchinson K, Lawrie D, Fedorak L, Macdonald D, Normand C, Pouliot JF. Health management program: factors influencing completion of therapy with high-dose interferon alfa-2b for high-risk melanoma. Curr Oncol. 2008 Jan;15(1):36-41. doi: 10.3747/co.2008.200. PMID 18317583