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

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ClinicalTrials.gov Identifier: NCT02333565
Recruitment Status : Unknown
Verified January 2015 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : January 7, 2015
Last Update Posted : January 7, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Tracking Information
First Submitted Date  ICMJE January 2, 2015
First Posted Date  ICMJE January 7, 2015
Last Update Posted Date January 7, 2015
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination of Everolimus and Octreotide LAR in Aggressive Recurrent Meningiomas
Official Title  ICMJE Combination of Everolimus and Octreotide LAR in Aggressive Recurrent Meningiomas.
Brief Summary To determine if combination of everolimus and octreotide exert an anti-tumoral activity in recurrent and/or aggressive meningiomas growth with limited adverse effects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Recurrent Meningiomas
  • Resistant Meningiomas
Intervention  ICMJE
  • Drug: Everolimus
  • Drug: Octreotide
Study Arms  ICMJE Experimental: Combinaison everolimus and octreotide
Interventions:
  • Drug: Everolimus
  • Drug: Octreotide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 6, 2015)
20
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02333565
Other Study ID Numbers  ICMJE 2014-09
2014-003694-42 ( EudraCT Number )
RCAPHM14_0080 ( Other Identifier: APHM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique Hopitaux De Marseille
Study Sponsor  ICMJE Assistance Publique Hopitaux De Marseille
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP