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

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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Recurrent Meningiomas; Resistant Meningiomas	Drug: Everolimus; Drug: Octreotide	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Combination of Everolimus and Octreotide LAR in Aggressive Recurrent Meningiomas.
• Study Start Date: January 2015
• Estimated Primary Completion Date: January 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Combinaison everolimus and octreotide	Drug: Everolimus; Drug: Octreotide

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Urielle DESALBRES, Director; 04.91.38.27.47; drci@ap-hm.fr

Locations

France

Assistance Publique Hôpitaux Marseille; Recruiting

Marseille, France, 13354

Contact: Thomas GRAILLON, CCA 04.91.38.55.33 thomas.graillon@ap-hm.fr

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

More Information

• Responsible Party: Assistance Publique Hopitaux De Marseille
• ClinicalTrials.gov Identifier: NCT02333565
• Other Study ID Numbers: 2014-09; 2014-003694-42 ( EudraCT Number ); RCAPHM14_0080 ( Other Identifier: APHM )
• First Posted: January 7, 2015
• Last Update Posted: January 7, 2015
• Last Verified: January 2015

Additional relevant MeSH terms:

Meningioma; Recurrence; Disease Attributes; Pathologic Processes; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases; Everolimus; Octreotide; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Gastrointestinal Agents; Antineoplastic Agents, Hormonal