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MeningiomaPhase 2NCT00859040

Monthly SOM230C for Recurrent or Progressive Meningioma

A Phase 2 study testing SOM230C in people with Meningioma, run by Patrick Y. Wen, MD at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this research study is to evaluate the effectiveness and safety of SOM230C in treating recurrent meningiomas. SOM230C is a newly discovered drug that may stop meningioma cells from growing abnormally. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Meningioma
What is being tested?
SOM230C
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
8 sitesUnited States
Study dates
Mar 2009to Jan 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 18 years of age or older
  • Radiographically measurable disease on contrast-enhanced MRI or CT images
  • Karnofsky Performance status of 60 or greater
  • Life expectancy of at least 3 months
  • Histologically confirmed diagnosis of recurrent or progressive intracranial meningioma(s). This includes benign, atypical, or malignant meningioma; patients with neurofibromatosis type 1 or 2 may participate. Participants without histological confirmation but a classic radiographic picture of meningioma may also enroll. Patients with neurofibromatosis type 2 and a classic radiographic picture of meningioma may also enroll without histological confirmation
  • At least ten unstained standard (4-5 micron) paraffin slides for immunohistochemistry. Participants who have not had a surgical procedure are exempt from this requirement
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  • Unequivocal evidence for tumor progression by MRI (or CT scan if MRI is contraindicated)
  • MRI or CT must be performed within 14 days of registration
  • Patients with malignant meningiomas who require corticosteroids must be on a stable dose for at least 5 days prior to baseline imaging.
  • For patients who have been treated with external beam radiation, interstitial brachytherapy, or radiosurgery, an interval of 4 or more weeks must have elapses from the completion of radiation therapy to study drug administration, and there must be evidence of tumor progression.
  • There is no limit on the number of prior therapies

Who cannot join

  • Any cytotoxic chemotherapy, radiation, immunotherapy, or experimental therapy within 4 weeks prior to study drug administration
  • Prior therapy with somatostatin, andy somatostatin analogue, or any other hormonal treatment prescribed for the purpose of treating meningioma
  • Major surgery within 4 weeks prior to study drug administration
  • Malabsorption syndrome, short bowel or chologenic diarrhea not controlled by specific therapeutic means
  • Poorly controlled diabetes mellitus
  • Symptomatic cholelithiasis
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  • Congestive heart failure, unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment
  • QTc > 450 msec
  • Risk factors for Torsades de Pointes such as hypokalemia (< 3.5 mmol/L) not corrected by treatment, hypomagnesemia (< 0.7 mmol/L or < 1.6 mg/dL) not corrected by treatment, cardiac failure, clinically significant/symptomatic bradycardia, or high-grade AV block
  • Concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes, or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism or cardiac failure
  • Concomitant medication(s) known to increase the QT interval within 4 weeks prior to study drug administration
  • Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis with serum bilirubin > 2x ULN, serum albumin < 0.67 LLN, or ALT or AST more than 2 x ULN
  • Any other primary malignancy within the past 3 years (with the exception of basal cell carcinoma or carcinoma in situ of the cervix)
  • Active or suspected acute or chronic, uncontrolled infection or any history of immunocompromise, including any positive HIV test result
  • Abnormal coagulation studies (PT or PTT elevated by 30% above normal limits)
  • Use of anticoagulant medications (not including anti-platelet medications)
  • Lab values as specified in the protocol
  • Any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the investigator
  • Pregnancy or lactation, or failure to practice a medically acceptable method of birth control
  • History of alcohol or drug abuse in the 6 month period before study enrollment
  • Participation in any clinical investigation with an investigational drug within 1 month prior to study drug administration
  • Known hypersensitivity to somatostatin analogues or any component of the pasireotide or octreotide LAR os s.c. formulations

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02115

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Northwestern University

    Chicago, Illinois, 60611

  • Duke University Medical Center, Preston Robert Tisch Brain Tumor Center

    Durham, North Carolina, 27710

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Phase II Study of Monthly SOM230C for Recurrent or Progressive Meningioma

The purpose of this research study is to evaluate the effectiveness and safety of SOM230C in treating recurrent meningiomas. SOM230C is a newly discovered drug that may stop meningioma cells from growing abnormally. This drug has been used in treatment of other tumors, and information from those other research studies suggests that SOM230C may help to stop the growth of meningiomas.

Read the detailed description
  • To enroll in the study, a sample of the participant's tumor tissue, stored from an earlier study, must be sent to a lab at the Dana-Farber/Harvard Cancer Center for diagnosis and special testing.
  • Prior to starting the study medication, participants will undergo a Octreotide scan. This is a special type of scan used to obtain information about certain tumors.
  • Participants will receive the study medication, SOM230C, via an injection into the buttocks every 28 days. Therefore, each treatment cycle lasts 28 days.
  • The following tests and procedures will be done prior to the first, second and third treatment cycles, and every three treatment cycles thereafter: Complete physical examination including neurological exam; vital signs; current medication and symptom review; blood samples and a pregnancy test (for women of child-bearing potential).
  • About 2/3 through the first treatment cycle (around day 22), participants will visit the research doctor for a complete physical examination including a neurological exam and blood work.
  • Participants will have ECGs done prior to their first treatment cycle, about 2/3 through the first and third treatment cycles (around day 22), prior to their sixth treatment cycle, and every three treatment cycles thereafter.
Conditions
Meningioma
Being tested
SOM230C
Keywords
recurrent intracranial meningioma(s), progressive intracranial meningioma(s)
Medical subject headings
Meningioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SOM230CDrug

    Also called pasireotide LAR

    Injection in the buttocks every 28 days

Study groups in NCT00859040
Study groupRoleWhat they receive
SOM230CExperimentalMonthly SOM230C (pasireotide LAR) - 60 mg intramuscularly (Single-Arm Trial)
Receives: Drug: SOM230C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6 Month Progression Free Survival

    Progression is defined using Modified Macdonald Criteria , using a >/= 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).

    Measured: 6 months

Secondary outcomes (5)

  1. Response Rate

    Number of participants to experience complete or partial response on study treatment.

    For response per Modified Macdonald Criteria, all measurable and evaluable lesions and sites must be assessed using the same techniques as baseline.

    1. Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients must be on no steroids.
    2. Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. The steroid dose at the time of the scan evaluation should be no greater than the maximum dose used in the first 8 weeks from initiation of therapy.

    Measured: 5 years

  2. Treatment-related Events

    All Grade 3-4-5 adverse events with a treatment attribution of probable, possible or definite based on CTCAE (v3.0) as reported on case report forms

    Measured: 5 years

  3. Median Progression-Free Survival

    Measured: 5 years

  4. Median Time to Progression

    Per protocol, the study's secondary objectives are to be evaluated "for the estimate of median ... PFS ... at time of interest." At this time, all study participants have been followed for progression for a minimum of 34 months (final patient to accrue to study was registered to trial on 06/14/2011), and study manuscript is currently being written-up with this information.

    Measured: 34 months

  5. Overall Survival

    Percentage of participants alive 34 months after initiating study treatment. Median Overall Survival has not yet been reached for one study group; therefore, we are reporting Overall Survival rates by the end of the study time frame.

    Measured: 34 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionDec 2011
  4. Study completionJan 2016

Resources

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
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00859040
Sponsor's protocol ID
08-266
Other IDs
CSOM230CUS09T
Status last verified
Sep 2017
First submitted
9 Mar 2009
Last updated
27 Oct 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SOM230C in people with Meningioma, run by Patrick Y. Wen, MD at 8 sites in United States.

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 22 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 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. 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?

Yes. Results are posted in the registry (first posted 16 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

6 Month Progression Free Survival (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00859040.

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 27 Oct 2017.

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