Clinical trial · Interventional
Comparison of Melatonin or Metformin and Dacarbazine Combination Versus Dacarbazine Alone in Disseminated Melanoma
Phase II Multicenter Randomized Study to Compare Dacarbazine With Melatonin or Metformin Versus Dacarbazine in the First Line Therapy of Disseminated Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Preliminary terminated due to inefficacy
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dacarbazine | Drug | Dacarbazine | ALIAS |
| Melatonin | Drug | — | UNRESOLVED |
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Dacarbazine with Metformin
- description
- 32 patients will receive Dacarbazine 1000 mg/m\^2 once every 28 days with Metformin 850 mg BID.
- interventionNames
- Drug: Metformin
- Drug: Dacarbazine
- type
- EXPERIMENTAL
- label
- Dacarbazine and Melatonin
- description
- 32 patients will receive Dacarbazine 1000 mg/m\^2 once every 28 days with Melatonin 3 mg before sleep daily.
- interventionNames
- Drug: Melatonin
- Drug: Dacarbazine
- type
- ACTIVE_COMPARATOR
- label
- Dacarbazine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDNovik 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. PMID 33749049