Melanoma
Conditions
Keywords
Melanoma, Melatonin, Metformin, Dacarbazine
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.
Interventions
DRUGMetformin
per os 850 mg BID
DRUGMelatonin
per os 3 mg daily
DRUGDacarbazine
IV 1 hour 1000 mg/m\^2 once in 28 days
Sponsors
N.N. Petrov National Medical Research Center of Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AE) incidence | until 30 days after last patient treatment visit | Incidence of AE classified using NCI Common Terminology Criteria for AE v4 |
| 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. |
| Immune system assessment | 23 months after FPFV | Following tests will be performed at baseline and each response assessment: * Lymphocyte subpopulations detection * Immunosuppressive factors measurements |
Countries
Russia
Outcome results
None listed