NCT02190838

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: N.N. Petrov National Medical Research Center of Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Metformin	per os 850 mg BID
DRUG	Melatonin	per os 3 mg daily
DRUG	Dacarbazine	IV 1 hour 1000 mg/m\^2 once in 28 days

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-12-12
• Completion: 2018-12-31
• First posted: 2014-07-15
• Last updated: 2019-11-25

Locations

3 sites across 1 country: Russia