Clinical trial NCT02190838: Comparison of Melatonin or Metformin and Dacarbazine Combination Versus Dacarbazine Alone in Disseminated Melanoma
Official title: Phase II Multicenter Randomized Study to Compare Dacarbazine With Melatonin or Metformin Versus Dacarbazine in the First Line Therapy of Disseminated Melanoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Melanoma
Keywords: Melanoma
Melatonin
Metformin
Dacarbazine
Lead sponsor: N.N. Petrov National Medical Research Center of Oncology
Sponsor class: OTHER
First posted: 2014-07-15
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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:

* 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

Primary outcomes:
measure: Response Rate
timeFrame: 23 months after FPFV
measure: Progression Free Survival
timeFrame: 23 months after FPFV
Secondary outcomes:
measure: Adverse events (AE) incidence
timeFrame: until 30 days after last patient treatment visit
measure: Metabolic Changes Incidence
timeFrame: 23 months after FPFV
measure: Immune system assessment
timeFrame: 23 months after FPFV
Other outcomes:
Locations:
city: St. Petersburg
country: Russian Federation
facility: N.N. Petrov Research Institute of Oncology Ambulatory Chemotherapy Department
city: St. Petersburg
country: Russian Federation
facility: N.N. Petrov Research Institute of Oncology Chemotherapy and Innovative Technologies Department
city: St.Petersburg
country: Russian Federation
facility: N.N. Petrov Research Institute of Oncology Clinical Diagnostic Department
Study officials:
affiliation: N.N. Petrov Research Institute of Oncology
name: Aleksei V. Novik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: N.N. Petrov Research Institute of Oncology
name: Irina A. Baldueva, MD, PhD, DSc
role: STUDY_DIRECTOR
References:
citation: 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.