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

Sponsor
N.N. Petrov National Medical Research Center of Oncology (Other)
Overall Status
Terminated
CT.gov ID
NCT02190838
Collaborator
(none)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
57 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Multicenter Randomized Study to Compare Dacarbazine With Melatonin or Metformin Versus Dacarbazine in the First Line Therapy of Disseminated Melanoma
Actual Study Start Date :
Apr 1, 2014
Actual Primary Completion Date :
Dec 12, 2015
Actual Study Completion Date :
Dec 31, 2018

Arms and Interventions

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:
  • SioforĀ® 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: Melatonin
    per os 3 mg daily
    Other Names:
  • Melaxen
  • Drug: Dacarbazine
    IV 1 hour 1000 mg/m^2 once in 28 days
    Other Names:
  • DTIC
  • 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
  • Outcome Measures

    Primary Outcome Measures

    1. Response Rate [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

    2. Progression Free Survival [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.

    Secondary Outcome Measures

    1. Adverse events (AE) incidence [until 30 days after last patient treatment visit]

      Incidence of AE classified using NCI Common Terminology Criteria for AE v4

    2. Metabolic Changes Incidence [23 months after FPFV]

      Nutritional status will be assessed using Nutritional Risk Index (NRI), Subjective global assessment (SGA), and Body Mass Index (BMI) tools.

    3. Immune system assessment [23 months after FPFV]

      Following tests will be performed at baseline and each response assessment: Lymphocyte subpopulations detection Immunosuppressive factors measurements

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 N.N. Petrov Research Institute of Oncology Ambulatory Chemotherapy Department St. Petersburg Russian Federation 197758
    2 N.N. Petrov Research Institute of Oncology Chemotherapy and Innovative Technologies Department St. Petersburg Russian Federation 197758
    3 N.N. Petrov Research Institute of Oncology Clinical Diagnostic Department St.Petersburg Russian Federation 191124

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    N.N. Petrov National Medical Research Center of Oncology
    ClinicalTrials.gov Identifier:
    NCT02190838
    Other Study ID Numbers:
    • MMM-1
    First Posted:
    Jul 15, 2014
    Last Update Posted:
    Nov 25, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by N.N. Petrov National Medical Research Center of Oncology
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 25, 2019