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

NCT02190838 | Terminated Phase 2 DMC

• 1 other identifier: MMM-1
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Melanoma; Melatonin; Metformin; Dacarbazine

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  23 months after FPFV

Secondary Outcomes (3)

• Adverse events (AE) incidence

  until 30 days after last patient treatment visit

• Metabolic Changes Incidence

  23 months after FPFV

• Immune system assessment

  23 months after FPFV

Study Arms (3)

Dacarbazine with Metformin

EXPERIMENTAL

32 patients will receive Dacarbazine 1000 mg/m\^2 once every 28 days with Metformin 850 mg BID.

Drug: Metformin; Drug: Dacarbazine

Dacarbazine and Melatonin

EXPERIMENTAL

32 patients will receive Dacarbazine 1000 mg/m\^2 once every 28 days with Melatonin 3 mg before sleep daily.

Drug: Melatonin; Drug: Dacarbazine

Dacarbazine

ACTIVE COMPARATOR

32 patients will receive Dacarbazine 1000 mg/m\^2 once every 28 days

Drug: Dacarbazine

Interventions

Metformin DRUG

per os 850 mg BID

Also known as: Siofor® 850

Dacarbazine with Metformin

Melatonin DRUG

per os 3 mg daily

Also known as: Melaxen

Dacarbazine and Melatonin

Dacarbazine DRUG

IV 1 hour 1000 mg/m\^2 once in 28 days

Also known as: DTIC

Dacarbazine; Dacarbazine and Melatonin; Dacarbazine with Metformin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• N.N. Petrov National Medical Research Center of Oncology: lead

Study Sites (3)

N.N. Petrov Research Institute of Oncology Clinical Diagnostic Department

Saint Petersburg, 191124, Russia

Location

N.N. Petrov Research Institute of Oncology Ambulatory Chemotherapy Department

Saint Petersburg, 197758, Russia

Location

N.N. Petrov Research Institute of Oncology Chemotherapy and Innovative Technologies Department

Saint Petersburg, 197758, Russia

Location

Related Publications (1)

• 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.

  PMID: 33749049 DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

Metformin; Melatonin; Dacarbazine

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Aleksei V. Novik, MD, PhD

  N.N. Petrov Research Institute of Oncology

  PRINCIPAL INVESTIGATOR

• Irina A. Baldueva, MD, PhD, DSc

  N.N. Petrov Research Institute of Oncology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2014
• First Posted: July 15, 2014
• Study Start: April 1, 2014
• Primary Completion: December 12, 2015
• Study Completion: December 31, 2018
• Last Updated: November 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (3)