Clinical trial · Interventional
Standard High-Dose Alpha Interferon Versus Intermittent High-Dose Alpha Interferon
Randomized, Multicenter Study for Adjuvant Treatment of Stage III Malignant Melanoma: Intermittent, High-Dose Intravenous Interferon Alpha-2b Versus Standard High-Dose Interferon Alpha-2b Therapy
NCT00226408CI-TRIAL-00000358unknownPhase 3ClinicalTrials.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)
The study protocol is being conducted to compare intermittent high-dose i.v. administation of interferon alpha-2b with the standard high-dose treatment by Kirkwood with distant metastasis free survival (DMFI) as a primary endpoint.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adjuvant | — | UNRESOLVED | — |
| Interferon Alpha | — | UNRESOLVED | — |
| Stage III Malignant Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interferon-alpha-2b | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- distant metastasis free survival/(DMFI )
Secondary outcomes (3)
- measure
- overall survival
- measure
- time to progression
- measure
- toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histological documentet cutaneous malognant melanoma * Stage IIIa, IIIb, IIIc (AJCC 2002) * R0 resection dating back no longer than 56 days * Performance status (ECOG o-1) * Bone marrow funktion: White cell count \> 3000 cells/ul, platletts \> 100000 cells/ul, hemoglobin \> 10 g/dl * Liver and kidney funktion: Serum creatinin \< 1.5 times upper limit of normal, AST and ALT \< 2.5 times upper limit of normal, Serum bilirubin \< 2 times upper limit of normal * Written inform consent Exclusion Criteria: * Confirmed distant metastasis * Choroid or mucosal melanoma * Pregnant or lactating women and women of childbearing potential not using a reliable form of contraception * Active autoimmun disease * patients with history of neuropsychiatric disease requiring hospitalization * Severe medical condition such us: * Florid hepatitis * Severe acute infection * Myocardial infarction within the past year,symptomatic angina pectoris * Grade III to IV congestive heart failure * serious pulmonary disease * HIV-positive patients with an AIDS - defining condition * treatment in another clinical drug trial within the last 30 days * A history of hypersensitivity to interferon alfa * History of maignant disease during the past 5 years (except for curatively treated skin carcinoma or in situ carcinoma) * Prior high dose interferon alfa therapy.Prior adjuvant low dose or intermediate-dose interferon alfa therapy is allowed
References
Publications (1)
- DERIVEDMohr P, Hauschild A, Trefzer U, Enk A, Tilgen W, Loquai C, Gogas H, Haalck T, Koller J, Dummer R, Gutzmer R, Brockmeyer N, Holzle E, Sunderkotter C, Mauch C, Stein A, Schneider LA, Podda M, Goppner D, Schadendorf D, Weichenthal M. Intermittent High-Dose Intravenous Interferon Alfa-2b for Adjuvant Treatment of Stage III Melanoma: Final Analysis of a Randomized Phase III Dermatologic Cooperative Oncology Group Trial. J Clin Oncol. 2015 Dec 1;33(34):4077-84. doi: 10.1200/JCO.2014.59.6932. Epub 2015 Oct 26. PMID 26503196