Status:
COMPLETED
Nordic Adjuvant IFN Melanoma Trial
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Melanoma
Adjuvant Therapy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The aim of this study is to evaluate the effect of giving adjuvant treatment with intermediate doses of interferon-alpha2b to patients operated for high risk melanoma. Patients are randomly assigned t...
Detailed Description
This is an open multicenter, prospective randomised phase III trial evaluating the efficacy of two different schedules of Interferon-alpha2b (IFN-alpha2b) administered in an adjuvant setting after ade...
Eligibility Criteria
Inclusion
- T4 N0 M0 - Thick primary melanoma: \> 4.0 mm Breslow depth, without lymph node involvement, or
- Tx N1-2 M0 Primary melanoma of any thickness with regional lymph node metastases confirmed by lymphadenectomy, or
- Tx N1-2 M0 Recurrent melanoma in regional lymph node(s) confirmed by lymphadenectomy.
- ECOG performance status of 0-1
- No active medical or psychiatric disorder requiring therapy that would prevent completion of protocol
- Written informed consent
Exclusion
- Patients with unknown primary site of melanoma or primary melanoma originating apart from the skin, except subungual melanoma
- Patients who have clinical, radiological/laboratory or pathological evidence of incompletely resected melanoma or distant metastatic disease
- Patients who have had prior adjuvant radiotherapy, chemotherapy, immunotherapy including preoperative infusion or perfusion therapy
- Female patients who are pregnant or lactating
Key Trial Info
Start Date :
November 1 1996
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
855 Patients enrolled
Trial Details
Trial ID
NCT01259934
Start Date
November 1 1996
End Date
June 1 2008
Last Update
December 14 2010
Active Locations (1)
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1
Karolinska Institutet, Karolinska University Hospital,
Stockholm, Sweden, S-171 76