Comparison of Melatonin or Metformin and Dacarbazine Combination Versus Dacarbazine Alone in Disseminated Melanoma
- Registration Number
- NCT02190838
- Lead Sponsor
- N.N. Petrov National Medical Research Center of Oncology
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 57
- Age >18.
- Obtained Inform Consent
- Morphologically confirmed disseminated Stage IV melanoma
- Eastern Collaborative Oncology Group Performance Status Scale 0 - 2.
- Expected survival >3 month
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dacarbazine with Metformin Dacarbazine 32 patients will receive Dacarbazine 1000 mg/m\^2 once every 28 days with Metformin 850 mg BID. Dacarbazine with Metformin Metformin 32 patients will receive Dacarbazine 1000 mg/m\^2 once every 28 days with Metformin 850 mg BID. Dacarbazine and Melatonin Melatonin 32 patients will receive Dacarbazine 1000 mg/m\^2 once every 28 days with Melatonin 3 mg before sleep daily. Dacarbazine and Melatonin Dacarbazine 32 patients will receive Dacarbazine 1000 mg/m\^2 once every 28 days with Melatonin 3 mg before sleep daily. Dacarbazine Dacarbazine 32 patients will receive Dacarbazine 1000 mg/m\^2 once every 28 days
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (3)
N.N. Petrov Research Institute of Oncology Ambulatory Chemotherapy Department
🇷🇺St. Petersburg, Russian Federation
N.N. Petrov Research Institute of Oncology Chemotherapy and Innovative Technologies Department
🇷🇺St. Petersburg, Russian Federation
N.N. Petrov Research Institute of Oncology Clinical Diagnostic Department
🇷🇺St.Petersburg, Russian Federation