Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pilot Study Evaluating the Efficacy and Safety of Metformin in Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01840007
Recruitment Status : Unknown
Verified February 2013 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
First Posted : April 25, 2013
Last Update Posted : April 25, 2013
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief Summary:
In western countries, melanoma represents a major mistake of public health by its frequency, lethality and the increasing of incidence. Surgery can cure melanoma diagnosed very early. In other cases, it exists a risk of recurrence of lymph node and visceral. At the stage of visceral metastases, the prognosis of melanoma is catastrophic, with a median survival of 6 months. Indeed, the reference chemotherapy by dacarbazine induces a very limited response rate of 10-20%, the ipilimumab which has been authorized in the second intention, has a response rate of 10%, and other available treatments don't have a superior efficiency. Metformin is an oral antidiabetic of biguanides family which acts by inducing the activation of AMPK, a molecule which is inactivated in many cancers including the melanoma. In agreement with these data, several preclinical studies suggested that metformin has antineoplastic activity. In the case of melanoma, a study published recently has showed that metformin inhibits proliferation of melanoma cells in vitro and we confirmed for our part these results in our laboratory (INSERM U895).

Condition or disease Intervention/treatment Phase
Metastatic Melanoma (Stage IIIC Non-résécable or no Surgically Curable or Stage IV With Classification AJCC) Drug: Metformin Group Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study Evaluating the Efficacy and Safety of Metformin in Melanoma
Study Start Date : August 2011
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : February 2014


Arm Intervention/treatment
Experimental: Metformin

The chosen posology is 2540 mg/day of metformin-base so 3 tablets/day of Glucophage ® 1000.

Patients should take 3 tablets/day at the rate of 1tablet in morning, noon and evening to favor the absorbtion and reduce the risk of gastrointestinal intolerance. In case of missed dose, patients will be allowed to take 2 tablets on the next grip. The drug will be presented in its officinale form of Glucophage ® 1000 with specifications indicated in the Vidal dictionary. It will be provided each month, to patient, 3 boxes of 30 tablets of Glucophage ® 1000. The patient will be asked to rate each day, on a calendar, the number of tablets of Glucophage ® 1000 effectively taken. It will also ask to the patient to bring back used boxes of Glucophage ® 1000 to count any tablets not taken.

Drug: Metformin Group

The chosen posology is 2540 mg/day of metformin-base so 3 tablets/day of Glucophage ® 1000.

Patients should take 3 tablets/day at the rate of 1tablet in morning, noon and evening to favor the absorbtion and reduce the risk of gastrointestinal intolerance. In case of missed dose, patients will be allowed to take 2 tablets on the next grip. The drug will be presented in its officinale form of Glucophage ® 1000 with specifications indicated in the Vidal dictionary. It will be provided each month, to patient, 3 boxes of 30 tablets of Glucophage ® 1000. The patient will be asked to rate each day, on a calendar, the number of tablets of Glucophage ® 1000 effectively taken. It will also ask to the patient to bring back used boxes of Glucophage ® 1000 to count any tablets not taken.





Primary Outcome Measures :
  1. Response rate [ Time Frame: Once time after 6 months of treatment by metformine ]

    The primary evaluation criteria is the response rate (response rate, RR) defined by the ratio between the total number of patients with a complete response (complete response, CR) or partial (partial response, PR) and the total number of patients in the study. Partial or complete responses will be defined by RECIST 1.1 (15) criteria :

    • Complete response: disappearance of all targets lesions
    • Partial response: decrease of at least 30% of the sum of the biggest diameters of each target lesion All others patients, including those for who the response couldn't be measured, will be considered non-responders.


Secondary Outcome Measures :
  1. the overall survival, the survival without progress (PFS), the tolerance, and the quality of life. [ Time Frame: 6 times ]
    • Overall survival (OS) is defined by the duration (number of days) between the start of treatment (J1) and the date of death from anything.
    • Progression-free survival (PFS) is defined by the duration (number of days) between the start of treatment (J1) and the observation of a progression or death. Tumor progression is defined by an increase of at least 20% of the sum of the biggest diameters of each target lesion.
    • The duration of the response is determined by the time (in days) between the date (visit) which is recorded a response to the treatment (complete or partial) and the date (visit) which is recorded an increase or the date of death.
    • To evaluate the quality of life, a questionnaire EORTC QLQ-C30 version 3 (16), validated in French, will be completed by the patient at visits V1 (J1), V3 (M2), V5 (M4) and V7 (M6) (Annex X).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major patients with metastatic melanoma (stage IIIC non-résécable or no surgically curable or stage IV with classification AJCC) in progression after a first-line of treatment by vemurafenib or chemotherapy, and non-eligible or non-responders to ipilimumab.

Metastases measurable by RECIST criteria. Hematologic, renal and hepatic appropriate functions. Negative pregnancy test.

Exclusion Criteria:

  • Patients with symptomatic brain metastases and Performans Status (PS)>2. Patients with carcinomatous meningitis. Pregnant or breathfeeding women. Patients with a contraindication to the metformine. HIV infection, active infection with HBV or HCV. Patients already treated with metformin in the context of diabetes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840007


Contacts
Layout table for location contacts
Contact: BAHADORAN Philippe, PhD +33492036484 bahadoran.p@chu-nice.fr

Locations
Layout table for location information
France
Bahadoran Recruiting
Nice, Alpes-Maritimes, France, 06200
Contact: BAHADORAN Philipp, PhD    +33492036484    bahadoran.p@chu-nice.fr   
Principal Investigator: BAHADORAN Philippe, Phd         
MORTIER Laurent Recruiting
Lille, Nord, France, 59000
Contact: MORTIER Laurent, PhD    +33 3.20.44.41.93    Laurent.mortier@chru-lille.fr   
Sub-Investigator: MORTIER Laurent, PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Layout table for investigator information
Principal Investigator: BAHADORAN Philippe, PHD Service de Dermatologie - Hôpital de l'Archet - CHU de Nice

Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01840007     History of Changes
Other Study ID Numbers: 10-PP-17
2010-024322-38 ( EudraCT Number )
First Posted: April 25, 2013    Key Record Dates
Last Update Posted: April 25, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Metformin
Hypoglycemic Agents
Melanoma
Nevi and Melanomas
Physiological Effects of Drugs