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

November 22, 2019 updated by: N.N. Petrov National Medical Research Center of Oncology

Phase II Multicenter Randomized Study to Compare Dacarbazine With Melatonin or Metformin Versus Dacarbazine in the First Line Therapy of Disseminated Melanoma

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • St. Petersburg, Russian Federation, 197758
        • N.N. Petrov Research Institute of Oncology Ambulatory Chemotherapy Department
      • St. Petersburg, Russian Federation, 197758
        • N.N. Petrov Research Institute of Oncology Chemotherapy and Innovative Technologies Department
      • St.Petersburg, Russian Federation, 191124
        • N.N. Petrov Research Institute of Oncology Clinical Diagnostic Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dacarbazine with Metformin
32 patients will receive Dacarbazine 1000 mg/m^2 once every 28 days with Metformin 850 mg BID.
Drug: Metformin
per os 850 mg BID
Other Names:
  • Siofor® 850
Drug: Dacarbazine
IV 1 hour 1000 mg/m^2 once in 28 days
Other Names:
  • DTIC
Experimental: Dacarbazine and Melatonin
32 patients will receive Dacarbazine 1000 mg/m^2 once every 28 days with Melatonin 3 mg before sleep daily.
Drug: Dacarbazine
IV 1 hour 1000 mg/m^2 once in 28 days
Other Names:
  • DTIC
Drug: Melatonin
per os 3 mg daily
Other Names:
  • Melaxen
Active Comparator: Dacarbazine
32 patients will receive Dacarbazine 1000 mg/m^2 once every 28 days
Drug: Dacarbazine
IV 1 hour 1000 mg/m^2 once in 28 days
Other Names:
  • DTIC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate
Time Frame: 23 months after FPFV
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
Time Frame: 23 months after FPFV
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events (AE) incidence
Time Frame: until 30 days after last patient treatment visit
Incidence of AE classified using NCI Common Terminology Criteria for AE v4
until 30 days after last patient treatment visit
Metabolic Changes Incidence
Time Frame: 23 months after FPFV
Nutritional status will be assessed using Nutritional Risk Index (NRI), Subjective global assessment (SGA), and Body Mass Index (BMI) tools.
23 months after FPFV
Immune system assessment
Time Frame: 23 months after FPFV

Following tests will be performed at baseline and each response assessment:

  • Lymphocyte subpopulations detection
  • Immunosuppressive factors measurements
23 months after FPFV

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

N.N. Petrov National Medical Research Center of Oncology

Investigators

  • Principal Investigator: Aleksei V. Novik, MD, PhD, N.N. Petrov Research Institute Of Oncology
  • Study Director: Irina A. Baldueva, MD, PhD, DSc, N.N. Petrov Research Institute Of Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

December 12, 2015

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

July 13, 2014

First Submitted That Met QC Criteria

July 13, 2014

First Posted (Estimate)

July 15, 2014

Study Record Updates

Last Update Posted (Actual)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 22, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMM-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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