Comparison of Melatonin or Metformin and Dacarbazine Combination Versus Dacarbazine Alone in Disseminated Melanoma

Phase II Multicenter Randomized Study to Compare Dacarbazine With Melatonin or Metformin Versus Dacarbazine in the First Line Therapy of Disseminated Melanoma

Treatment of disseminated melanoma is still a difficult issue. Obvious achievements of recent years proves efficacy of immunologic approachees in this field. The ability of melatonin and metformin to decrease metabolic immunosuppression was shown in many experimental studies. Some literature data confirm the possibility of increasing efficacy of melatonin with dacarbazine (DTIC) and metformin with DTIC combinations. We hypothesized that this combinations could be more effective than DTIC monotherapy in terms of response rate and time to progression.

Inclusion Criteria:

• Age >18.
• Obtained Inform Consent
• Morphologically confirmed disseminated Stage IV melanoma
• Eastern Collaborative Oncology Group Performance Status Scale 0 - 2.
• Expected survival >3 month

Exclusion Criteria:

• Evidence of active brain lesions (brain lesions after stereotaxic ray therapy allowed)
• Evidence of liver and bone marrow clinically meaningful disfunction
• Severe uncontrolled concomitant conditions and diseases
• Pregnancy or lactation
• Systemic therapy for disseminated melanoma
• Second malignancy
• Diabetes mellitus requiring drug therapy
• Any condition preventing study participation by investigator opinion