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Preliminary terminated due to inefficacy
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dacarbazine with Metformin | Experimental | 32 patients will receive Dacarbazine 1000 mg/m^2 once every 28 days with Metformin 850 mg BID. |
|
| Dacarbazine and Melatonin | Experimental | 32 patients will receive Dacarbazine 1000 mg/m^2 once every 28 days with Melatonin 3 mg before sleep daily. |
|
| Dacarbazine | Active Comparator | 32 patients will receive Dacarbazine 1000 mg/m^2 once every 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | per os 850 mg BID |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 23 months after FPFV |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AE) incidence | Incidence of AE classified using NCI Common Terminology Criteria for AE v4 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aleksei V. Novik, MD, PhD | N.N. Petrov Research Institute of Oncology | Principal Investigator |
| Irina A. Baldueva, MD, PhD, DSc | N.N. Petrov Research Institute of Oncology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| N.N. Petrov Research Institute of Oncology Clinical Diagnostic Department | Saint Petersburg | 191124 | Russia | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33749049 | Derived | 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. |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D008550 | Melatonin |
| D003606 | Dacarbazine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D014363 |
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| Melatonin | Drug | per os 3 mg daily |
|
|
| Dacarbazine | Drug | IV 1 hour 1000 mg/m^2 once in 28 days |
|
|
| 23 months after FPFV |
| Immune system assessment | Following tests will be performed at baseline and each response assessment:
| 23 months after FPFV |
| N.N. Petrov Research Institute of Oncology Ambulatory Chemotherapy Department |
| Saint Petersburg |
| 197758 |
| Russia |
| N.N. Petrov Research Institute of Oncology Chemotherapy and Innovative Technologies Department | Saint Petersburg | 197758 | Russia |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D014226 | Triazenes |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |