drugset / Trial / NCT02190838

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

NCT02190838

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2014-04
Primary completion
2015-12-12
Completion
2018-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Dacarbazine Small molecule 1000 mg/m2 Intravenous
Subject Melatonin Small molecule 3 mg Oral
Subject Metformin Small molecule 850 mg Oral

Indications