Status:
COMPLETED
Efficacy and Safety of High-dose Interferon Alfa-2b (Intron A®) for the Adjuvant Treatment of Malignant Melanoma (Study P04083)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Melanoma
Eligibility:
All Genders
18-70 years
Brief Summary
The aim of this observational study is to document the efficacy and tolerability of high-dose interferon therapy in adult participants with malignant melanoma at high risk of relapse and to compare th...
Detailed Description
Observational study to evaluate the tolerability and efficacy (vs historical controls) of a high-dose therapy scheme with interferon-α-2b (IntronA®): Adjuvant treatment with interferon-α-2 has been d...
Eligibility Criteria
Inclusion
- Male and female participants
- Age 18-70 years
- Malignant melanoma stage II or III (\>/= 1.5 mm tumor thickness, no distant metastases or Malignant melanoma with lymph node metastases or Lymph node metastases with unknown primary tumor
- An excision border of at least 2 cm around the primary tumor
- Therapy must start within 12 weeks after surgery of the tumor/of the lymph node metastases
- ECOG status 0-1 (= Karnofsky Index \>/= 80)
- Laboratory parameters
- Hematocrit \>= 33%
- Leukocytes \>= 3000/μl
- Thrombocytes \>= 100000/μl
- Alanine aminotransferase(ALT) \<= 2x normal values
- Bilirubin \<= 2x normal values
Exclusion
- Known allergy to one of the medications or any of its component parts
- Refusal on the part of participants capable of childbearing to use a reliable contraceptive
- Lactating mothers
- Presence of distant metastases
- Another primary tumor of different histological origin than corresponding to the indication (except when the relapse-free interval is \> 5 years, or the tumor is a cervical carcinoma in situ, a basal cell carcinoma or cutaneous squamous cell carcinoma)
- Participants on corticosteroid treatment or treatment with an immunomodulating substance
- Preexisting psychiatric illness, particularly serious depression
- Prior adjuvant radio-, chemo-, or immuno-therapy
- Treatment with an investigational drug within the prior 30 days
- Participant history that includes cardiac arrhythmia, cardiac insufficiency requiring treatment, or anthracycline administration
- Myocardial infarction within the prior year
- An unstable medical condition (apart from the indication) that in the judgment of the investigating physician excludes the participants from the study
- Psoriasis (a relative exclusion criterion, since interferon can aggravate psoriasis; decision to be based on risk/benefit analysis)
Key Trial Info
Start Date :
December 1 1996
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT00749684
Start Date
December 1 1996
End Date
September 1 2009
Last Update
October 19 2015
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