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

Primary Purpose

Melanoma

Status
Terminated
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Metformin
Melatonin
Dacarbazine
Sponsored by
N.N. Petrov National Medical Research Center of Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Melanoma, Melatonin, Metformin, Dacarbazine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • N.N. Petrov Research Institute of Oncology Ambulatory Chemotherapy Department
  • N.N. Petrov Research Institute of Oncology Chemotherapy and Innovative Technologies Department
  • N.N. Petrov Research Institute of Oncology Clinical Diagnostic Department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Dacarbazine with Metformin

Dacarbazine and Melatonin

Dacarbazine

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Adverse events (AE) incidence
Incidence of AE classified using NCI Common Terminology Criteria for AE v4
Metabolic Changes Incidence
Nutritional status will be assessed using Nutritional Risk Index (NRI), Subjective global assessment (SGA), and Body Mass Index (BMI) tools.
Immune system assessment
Following tests will be performed at baseline and each response assessment: Lymphocyte subpopulations detection Immunosuppressive factors measurements

Full Information

First Posted
July 13, 2014
Last Updated
November 22, 2019
Sponsor
N.N. Petrov National Medical Research Center of Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT02190838
Brief Title
Comparison of Melatonin or Metformin and Dacarbazine Combination Versus Dacarbazine Alone in Disseminated Melanoma
Official Title
Phase II Multicenter Randomized Study to Compare Dacarbazine With Melatonin or Metformin Versus Dacarbazine in the First Line Therapy of Disseminated Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
Preliminary terminated due to inefficacy
Study Start Date
April 2014 (Actual)
Primary Completion Date
December 12, 2015 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
N.N. Petrov National Medical Research Center of Oncology

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Melanoma, Melatonin, Metformin, Dacarbazine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dacarbazine with Metformin
Arm Type
Experimental
Arm Description
32 patients will receive Dacarbazine 1000 mg/m^2 once every 28 days with Metformin 850 mg BID.
Arm Title
Dacarbazine and Melatonin
Arm Type
Experimental
Arm Description
32 patients will receive Dacarbazine 1000 mg/m^2 once every 28 days with Melatonin 3 mg before sleep daily.
Arm Title
Dacarbazine
Arm Type
Active Comparator
Arm Description
32 patients will receive Dacarbazine 1000 mg/m^2 once every 28 days
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Siofor® 850
Intervention Description
per os 850 mg BID
Intervention Type
Drug
Intervention Name(s)
Melatonin
Other Intervention Name(s)
Melaxen
Intervention Description
per os 3 mg daily
Intervention Type
Drug
Intervention Name(s)
Dacarbazine
Other Intervention Name(s)
DTIC
Intervention Description
IV 1 hour 1000 mg/m^2 once in 28 days
Primary Outcome Measure Information:
Title
Response Rate
Description
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
Title
Progression Free Survival
Description
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
Secondary Outcome Measure Information:
Title
Adverse events (AE) incidence
Description
Incidence of AE classified using NCI Common Terminology Criteria for AE v4
Time Frame
until 30 days after last patient treatment visit
Title
Metabolic Changes Incidence
Description
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
Title
Immune system assessment
Description
Following tests will be performed at baseline and each response assessment: Lymphocyte subpopulations detection Immunosuppressive factors measurements
Time Frame
23 months after FPFV

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksei V. Novik, MD, PhD
Organizational Affiliation
N.N. Petrov Research Institute of Oncology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Irina A. Baldueva, MD, PhD, DSc
Organizational Affiliation
N.N. Petrov Research Institute of Oncology
Official's Role
Study Director
Facility Information:
Facility Name
N.N. Petrov Research Institute of Oncology Ambulatory Chemotherapy Department
City
St. Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
N.N. Petrov Research Institute of Oncology Chemotherapy and Innovative Technologies Department
City
St. Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
N.N. Petrov Research Institute of Oncology Clinical Diagnostic Department
City
St.Petersburg
ZIP/Postal Code
191124
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33749049
Citation
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.
Results Reference
derived

Learn more about this trial

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

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