Status:
TERMINATED
Comparison of Melatonin or Metformin and Dacarbazine Combination Versus Dacarbazine Alone in Disseminated Melanoma
Lead Sponsor:
N.N. Petrov National Medical Research Center of Oncology
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT02190838
Start Date
April 1 2014
End Date
December 31 2018
Last Update
November 25 2019
Active Locations (3)
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1
N.N. Petrov Research Institute of Oncology Clinical Diagnostic Department
Saint Petersburg, Russia, 191124
2
N.N. Petrov Research Institute of Oncology Ambulatory Chemotherapy Department
Saint Petersburg, Russia, 197758
3
N.N. Petrov Research Institute of Oncology Chemotherapy and Innovative Technologies Department
Saint Petersburg, Russia, 197758