Combination of Everolimus and Octreotide LAR in Aggressive Recurrent Meningiomas (CEVOREM)

Combination of Everolimus and Octreotide LAR in Aggressive Recurrent Meningiomas.

To determine if combination of everolimus and octreotide exert an anti-tumoral activity in recurrent and/or aggressive meningiomas growth with limited adverse effects.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Urielle DESALBRES, Director
  • Phone Number: 04.91.38.27.47
  • Email: drci@ap-hm.fr

Study Locations

      • Marseille, France, 13354
        • ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male and Female patients ≥ 18 years old with no maximum limited of age
  • Histologically proven meningioma grade II and III; grade I meningioma may also be included, if progression is documented (see criteria 3), particularly in case of skull base location
  • Progression is defined on 2 different MRI as an increase of meningioma's surface ≥ 5% by 3 months period (i.e. an increase of 5% over 3 months, 10% over 6 months, 15% over 9 months…) or as the apparition of a new unequivocal neurological symptom related to the meningioma. We considered as a new unequivocal neurological symptom a new occurring neurological symptom as, for instance, hemiparesia, oculomotor nerve palsy, visual loss, facial nerve palsy, facial neuralgia, directly related to meningioma and suggesting meningioma growth with increase of meningioma compression on neurological structures despite no increasing size on MRIs.
  • Patients must have failed surgery, and not amenable to a new curative intended surgery
  • Patients must have failed radiotherapy and/or radiosurgery
  • Prior chemotherapy is allowed, if progression under the cytotoxic agent is clearly documented. An interval of 4 weeks after the last administration of the cytotoxic agent is warranted. Number of prior chemotherapies is not limited.
  • Patients who have given their written consent
  • Patients affiliated to a social insurance regime
  • Adequate bone marrow function as shown by: Absolute Neutrophil Count ≥ 1.5 x 109/L,
  • Platelets ≥ 100 x 109/L, Hb >9 g/dL
  • Adequate liver function as shown by; serum bilirubin ≤ 1.5 x Upper Limit of Normal; International Normalized Ratio < 1.3; alanine aminotransferase and aspartate aminotransferase ≤ 2.5 x Upper Limit of Normal - Adequate renal function: serum creatinine ≤ 1.5 x Upper Limit of Normal - Fasting serum cholesterol ≤ 300 mg/dL OR ≤ 7.75 mmol/L and fasting triglycerides ≤ 2.5 x Upper Limit of Normal. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after dyslipidemia treatment initiation.

Exclusion Criteria:

  • Patients with symptomatic lithiasis
  • Contra indication to octreotide and everolimus
  • Women of child-bearing age who are using no effective means of contraception
  • Pregnant or breast-feeding women or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes
  • Patients receiving other investigational agents or who received an investigative drug or therapy within the last 30 days.
  • Known intolerance or hypersensitivity to octreotide, everolimus or other rapamycin (sirolimus, temsirolimus)
  • Uncontrolled diabetes mellitus defined by HbA1c>8.5%
  • Patients who have any severe and/or uncontrolled medical condition:

unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤ 6 months prior to inclusion, serious uncontrolled cardiac arrhythmia, active or uncontrolled severe infection, cirrhosis, chronic active hepatitis or chronic persistent hepatitis, severely impaired lung function (spirometry and Diffusing Capacity of the lung for carbon monoxide 50% or less of normal and O2 saturation 88% or less at rest on room air), active, bleeding diathesis

  • Patients receiving chronic treatment with immunosuppressive agent
  • Patients with a known history of HIV seropositivity
  • Patients who have a history of another primary malignancy ≤ 3 years, with the exceptions of non-melanoma skin cancer, and carcinoma in situ of uterine cervix.
  • Females patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combinaison everolimus and octreotide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Progression Free Survival rate
Time Frame: 36 months
Measured by the number of individuals without progression disease at 6 months, according to Response Assessment in Neuro-Oncology criteria's.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2015

Primary Completion (Actual)

January 21, 2019

Study Completion (Actual)

May 24, 2023

Study Registration Dates

First Submitted

January 2, 2015

First Submitted That Met QC Criteria

January 6, 2015

First Posted (Estimated)

January 7, 2015

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Recurrent Meningiomas

Clinical Trials on Octreotide

3
Subscribe