Comparison of Melatonin or Metformin and Dacarbazine Combination Versus Dacarbazine Alone in Disseminated Melanoma

Melanoma Clinical Trial

Official title:

Phase II Multicenter Randomized Study to Compare Dacarbazine With Melatonin or Metformin Versus Dacarbazine in the First Line Therapy of Disseminated Melanoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02190838
• Other study ID #: MMM-1
• Status: Terminated
• Phase: Phase 2
• Start date: April 2014
• Est. completion date: December 31, 2018

Study information

• Verified date: September 2019
• Source: N.N. Petrov National Medical Research Center of Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 57
• Est. completion date: December 31, 2018
• Est. primary completion date: December 12, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• Metformin
per os 850 mg BID
• Melatonin
per os 3 mg daily
• Dacarbazine
IV 1 hour 1000 mg/m^2 once in 28 days

Locations

Country	Name	City	State
Russian Federation	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

Sponsors (1)

Lead Sponsor	Collaborator
N.N. Petrov National Medical Research Center of Oncology

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Adverse events (AE) incidence	Incidence of AE classified using NCI Common Terminology Criteria for AE v4	until 30 days after last patient treatment visit
Secondary	Metabolic Changes Incidence	Nutritional status will be assessed using Nutritional Risk Index (NRI), Subjective global assessment (SGA), and Body Mass Index (BMI) tools.	23 months after FPFV
Secondary	Immune system assessment	Following tests will be performed at baseline and each response assessment: Lymphocyte subpopulations detection; Immunosuppressive factors measurements	23 months after FPFV