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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dacarbazine with Metformin

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

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

per os 850 mg BID

Dacarbazine

Intervention Type DRUG

IV 1 hour 1000 mg/m\^2 once in 28 days

Dacarbazine and Melatonin

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

Group Type EXPERIMENTAL

Melatonin

Intervention Type DRUG

per os 3 mg daily

Dacarbazine

Intervention Type DRUG

IV 1 hour 1000 mg/m\^2 once in 28 days

Dacarbazine

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

Group Type ACTIVE_COMPARATOR

Dacarbazine

Intervention Type DRUG

IV 1 hour 1000 mg/m\^2 once in 28 days

Interventions

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Metformin

per os 850 mg BID

Intervention Type DRUG

Melatonin

per os 3 mg daily

Intervention Type DRUG

Dacarbazine

IV 1 hour 1000 mg/m\^2 once in 28 days

Intervention Type DRUG

Other Intervention Names

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Siofor® 850 Melaxen DTIC

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No