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

N.N. Petrov National Medical Research Center of Oncology

Status and phase: Terminated; Phase 2

Conditions: Melanoma

Treatments: Drug: Dacarbazine; Drug: Metformin; Drug: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT02190838

MMM-1

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 3 patient groups

Dacarbazine with Metformin

Experimental group

Description:

32 patients will receive Dacarbazine 1000 mg/m\^2 once every 28 days with Metformin 850 mg BID.

Treatment:

Drug: Metformin

Drug: Dacarbazine

Dacarbazine and Melatonin

Experimental group

Description:

32 patients will receive Dacarbazine 1000 mg/m\^2 once every 28 days with Melatonin 3 mg before sleep daily.

Treatment:

Drug: Melatonin

Drug: Dacarbazine

Dacarbazine

Active Comparator group

Description:

32 patients will receive Dacarbazine 1000 mg/m\^2 once every 28 days

Treatment:

Drug: Dacarbazine