A Phase 2 interventional study of Metformin and Melatonin in Melanoma, sponsored by N.N. Petrov National Medical Research Center of Oncology. Terminated at 3 sites in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-25.
Sponsored by N.N. Petrov National Medical Research Center of Oncology · Phase 2, Interventional, and Treatment
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.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 57 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →N.N. Petrov National Medical Research Center of Oncology is the lead sponsor of 26 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
32 patients will receive Dacarbazine 1000 mg/m\^2 once every 28 days with Metformin 850 mg BID.
Drug: Metformin · Drug: Dacarbazine
32 patients will receive Dacarbazine 1000 mg/m\^2 once every 28 days with Melatonin 3 mg before sleep daily.
Drug: Melatonin · Drug: Dacarbazine
32 patients will receive Dacarbazine 1000 mg/m\^2 once every 28 days
Drug: Dacarbazine
per os 850 mg BID
Also known as: Siofor® 850
per os 3 mg daily
Also known as: Melaxen
IV 1 hour 1000 mg/m\^2 once in 28 days
Also known as: DTIC
Response Rate
Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. ORR is defined as the proportion of patients with a best overall response of complete response or partial response
Time frame: 23 months after FPFV
Progression Free Survival
As per RECIST v1.1. progression-free survival (PFS) is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause.
Time frame: 23 months after FPFV
Adverse events (AE) incidence
Incidence of AE classified using NCI Common Terminology Criteria for AE v4
Time frame: until 30 days after last patient treatment visit
Metabolic Changes Incidence
Nutritional status will be assessed using Nutritional Risk Index (NRI), Subjective global assessment (SGA), and Body Mass Index (BMI) tools.
Time frame: 23 months after FPFV
Immune system assessment
Following tests will be performed at baseline and each response assessment: * Lymphocyte subpopulations detection * Immunosuppressive factors measurements
Time frame: 23 months after FPFV
Plan to share: No
This study is terminated, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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N.N. Petrov National Medical Research Center of Oncology