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

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

Outcome

Missed primary endpoint

Stopped: “Preliminary terminated due to inefficacy”

paper Melatonin and Metformin Failed to Modify the Effect of Dacarbazine in Melanoma. PMID 33749049 ↗

paper ORR was 7% and did not differ among the treatment groups. PMID 33749049 ↗

Publications

• Novik AV, Protsenko SA, Baldueva IA, Berstein LM, Anisimov VN, Zhuk IN, Semenova AI, Latipova DK, Tkachenko EV, Semiglazova TY. Melatonin and Metformin Failed to Modify the Effect of Dacarbazine in Melanoma. Oncologist. 2021 May;26(5):364-e734. doi: 10.1002/onco.13761. Epub 2021 Apr 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dacarbazine	Small molecule	1000 mg/m2	Intravenous
Subject	Melatonin	Small molecule	3 mg	Oral
Subject	Metformin	Small molecule	850 mg	Oral

Indications