Efficacy and Safety of High-dose Interferon Alfa-2b (Intron A®) for the Adjuvant Treatment of Malignant Melanoma (Study P04083)
- Conditions
- Melanoma
- Interventions
- Biological: Interferon α-2b
- Registration Number
- NCT00749684
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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 them with the survival times and relapse rates in previous studies (historical control).
- 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 demonstrated in a number of studies to have an antiproliferative effect on malignant melanoma. In these cases a response rate of up to 20% could be achieved with a dose of 10 million IU or more 3x/week or daily. Kirkwood et al. showed in a study carried out in ECOG (the Eastern Cooperative Oncology Group, study no. 1684) that there was a clear and significant survival advantage versus the observation group with the following dose:
20 mio IU/m² interferon-α-2b (IntronA®) 5x/week iv over the course of one month followed by 11 months with 10 mio IU/m² 3x/week sc.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 138
-
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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Adults with malignant melanoma at high risk of relapse Interferon α-2b Adults with malignant melanoma of the following stages: * II and III (\>/= 1.5 mm Breslow thickness without distant metastases * melanoma with lymph node metastases
- Primary Outcome Measures
Name Time Method Number of Participants With Disease Recurrence Throughout 12 months of treatment and 24 months of follow-up Number of participants with disease recurrence was being measured.
Relapse Free Survival Time Throughout 12 months of treatment and 24 months of follow-up Median time to recurrence according to Kaplan Maier evaluation
- Secondary Outcome Measures
Name Time Method