Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
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.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
