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

Phase 2TerminatedNCT02190838

N.N. Petrov National Medical Research Center of Oncology57 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Melanoma

Interventions

Metformin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

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

Saint Petersburg, Russia

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

Saint Petersburg, Russia

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

Saint Petersburg, Russia

Outcomes

Primary Outcomes

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

Secondary Outcomes

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