Comparison of Melatonin or Metformin and Dacarbazine Combination Versus Dacarbazine Alone in Disseminated Melanoma
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
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:
Drug: Dacarbazine
IV 1 hour 1000 mg/m^2 once in 28 days
Other Names:
|
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:
Drug: Dacarbazine
IV 1 hour 1000 mg/m^2 once in 28 days
Other Names:
|
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:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
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:
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Evidence of active brain lesions (brain lesions after stereotaxic ray therapy allowed)
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Evidence of liver and bone marrow clinically meaningful disfunction
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Severe uncontrolled concomitant conditions and diseases
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Pregnancy or lactation
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Systemic therapy for disseminated melanoma
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Second malignancy
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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.- MMM-1