Recurrent MeningiomasPhase 2CEVOREMNCT02333565
Combination of Everolimus and Octreotide LAR in Aggressive Recurrent Meningiomas
A Phase 2 study testing Everolimus and Octreotide in people with Recurrent Meningiomas and Resistant Meningiomas, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Meningiomas, Resistant Meningiomas
- What is being tested?
- Everolimus and Octreotide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jan 2015to 24 May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Recurrent Meningiomas, Resistant Meningiomas
- Being tested
- Everolimus, Octreotide
- Medical subject headings
- Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
OctreotideDrug
| Study group | Role | What they receive |
|---|---|---|
| Combinaison everolimus and octreotide | Experimental | Not described Receives: Drug: Everolimus; Drug: Octreotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Progression Free Survival rate
Measured by the number of individuals without progression disease at 6 months, according to Response Assessment in Neuro-Oncology criteria's.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study start22 Jan 2015
- Primary completion21 Jan 2019
- Study completion24 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent MeningiomasStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333565
- Sponsor's protocol ID
- 2014-09
- Other IDs
- 2014-003694-42, RCAPHM14_0080, 2014
- Acronym
- CEVOREM
- Status last verified
- May 2023
- First submitted
- 2 Jan 2015
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Everolimus and Octreotide LAR in Aggressive Recurrent Meningiomas.
- ClinicalTrials.gov ID
- NCT02333565
- Acronym / sponsor ID
- CEVOREM / 2014-09
- Conditions
- Recurrent Meningiomas, Resistant Meningiomas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 22 Jan 2015 (actual)
- Primary completion
- 21 Jan 2019 (actual)
- Study completion
- 24 May 2023 (actual)
- First posted
- 7 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combinaison everolimus and octreotide | Experimental | Drug: Everolimus, Drug: Octreotide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Everolimus | Drug | Combinaison everolimus and octreotide |
| Octreotide | Drug | Combinaison everolimus and octreotide |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Everolimus and Octreotide in people with Recurrent Meningiomas and Resistant Meningiomas, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Progression Free Survival rate (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.