| Methods |
Design: open label 5‐arm parallel, patients stratified by site of distant metastasis (M1a,b,c) and lactate dehydrogenase (LDH) level
No of centres: 64
Recruitment and setting: multi‐centre study across 8 European countries
Recruitment period: 08/02‐01/06
Observation period: 14.9‐56.5 months
Ethical approval: yes |
| Participants |
No. of patients: 488 patients evaluated (389 relevant to this review)
Condition: melanoma, stage IV without brain metastasis
Demographics: men: 250, women: 238
Informed consent: yes |
| Interventions |
Interventional treatment: thymosin α1; dose/schedule: IG1: 1.6 mg s.c.; IG2: 3.2 mg s.c. or IG3: 6.4 mg s.c. (d8‐11 and d15‐18) of every chemotherapy cycle
Control treatment: no treatment
Basic treatment: dacarbazine 800 mg/m² i.v. every 4 weeks for a maximum of six cycles; interferon α (IFNα) 3 MIU s.c. (d11,18) of every chemotherapy cycle |
| Outcomes |
Outcome measures: survival, response, toxicity (AEs of chemo‐/radiotherapy), safety (AEs of thymic peptides), other |
| Notes |
Method: sample size calculation was performed, accordingly 95 patients would be required in each arm; the original study design scheduled a four arm trial, but after preliminary analysis, which suggested a dose‐response relation the protocol was extended to integrate a fifth arm with a dose of thymosin α1 dose of 6.4 mg; sample size calculation was performed, accordingly 95 patients would be required in each arm
Participants: only 4 of the 5 arms had a control group in accordance with the selection criteria of the review (the other arm was controlled by IFNα)
Outcomes: AEs of thymic peptides not reported differentially; side effects of chemotherapy were not scored using standardized criteria
Funding: supported by sigma‐tau and SciClone Pharmaceuticals |
