Melanoma of cutaneous origin with regional lymph-node metastasis radically resected Cancer Melanoma of cutaneous origin with regional lymph-node metastasis radically resected
Conditions
Interventions
Dose-Dense/Dose-Intense arm: IFN alpha-2b 20 MU/m^2/day intravenously five days a week for four weeks, repeated for four times on weeks nine to 12, 17 to 20, 25 to 28
Standard arm: IFN alpha-2b 20 MU
Sponsors
Italian Melanoma Intergroup - IMI (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Primary melanoma of any tumour stage in presence of N1 regional lymph node metastases detected at elective or selective lymph node dissection with clinically not apparent regional lymph node metastases (designed CS1PS2, any TpN1M0) 2. Clinically apparent N1 regional lymph node involvement synchronous with primary melanoma of T1-4 (designed CS2PS2, any TcN1M0) 3. Regional lymph node recurrence at any interval after appropriate surgery for primary melanoma of any depth (designed CS2R, TxrN1M0) 4. ECOG performance status (PS) zero to one 5. Age 18 to 70 6. Absence of active medical or psychiatric troubles requiring medical or pharmacological interventions 7. Absence of thyroid or auto-immune pathology 8. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with non-cutaneous primary melanoma 2. Clinical or pathological evidence of not completely resected melanoma or of lymph-node metastases 3. Clinical history of progressed neoplasia, except for the in situ carcinoma of the cervix and of radically treated basal carcinomas 4. Patients requiring a continuous treatment with steroids, non-steroid antiinflammatory drugs or other inhibitors of the prostaglandins synthesis, antihistaminic (cimetidine, ranitidine, famotidine and nazatidine) or other known immunomodulators 5. Patients with history of (ventricular or supraventricular) heart rhythm troubles needing treatment, or congestive heart failure (class New York Heart Association [NYHA] more than two) 6. Patients with organic brain syndrome or significant deterioration of the basal cognitive function or with any psychiatric trouble which may hinder the complete participation in the protocol or which may be exacerbated from the IFN therapy (e.g. depression) 7. Patients previously submitted to adjuvant therapy, chemotherapy, immunotherapy, including any perfusion therapy before surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Toxicity 2. Disease free survival | — |
Countries
Italy
Outcome results
None listed