Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT00895622 : Observation or Radiation Therapy in Treating Patients With Grade I, Grade II, or Grade III Meningioma
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
DISEASE CHARACTERISTICS:

- Histologically confirmed meningioma, meeting 1 of the following criteria:

- Low-risk disease, as defined by the following:

- Newly diagnosed, WHO grade I disease that was gross totally resected
(Simpson's grade I, II, or III resection with no residual nodular
enhancement on postoperative imaging) or subtotally resected (residual
nodular enhancement or Simpson grade IV or V resection)

- Intermediate-risk disease, as defined by the following:

- Newly diagnosed, WHO grade II disease that was gross totally resected OR
recurrent WHO grade I disease irrespective of the resection extent

- High-risk disease, as defined by 1 of the following:

- Newly diagnosed or recurrent WHO grade III disease of any resection extent

- Recurrent WHO grade II disease of any resection extent

- Newly diagnosed, WHO grade II disease that was subtotally resected

- Patients with newly diagnosed disease must have had a histologic diagnosis within the
past 6 months AND have undergone pre- and post-operative MRIs within the past 3
months

- Patients with recurrent/progressive intermediate- or high-risk disease who have not
undergone recent surgery must have documentation of recurrence or progression by MRI
within the past 3 months

- No extracranial or multiple meningioma and/or hemangiopericytoma

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1

- Negative pregnancy test (for patients enrolled in groups 2 or 3)

- Fertile patients must use effective contraception (for patients enrolled in groups 2
or 3)

- Able to receive gandolinium

- No other invasive malignancy within the past 3 years except for nonmelanoma skin
cancer or carcinoma in situ of the breast, oral cavity, or cervix

- No severe, active comorbidity including, but not limited to, any of the following:

- Unstable angina and/or congestive heart failure requiring hospitalization

- Transmural myocardial infarction within the past 6 months

- Acute bacterial and/or fungal infection requiring IV antibiotics

- Chronic obstructive pulmonary disease exacerbation or respiratory illness
requiring hospitalization or that would preclude study treatment

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

- Known HIV positivity or AIDS, based upon the current CDC definition

- No evidence of active connective tissue disorders (e.g., lupus erythematosus
and/or scleroderma) (for patients enrolled in groups 2 or 3)

- No other major medical illness or psychiatric impairment that, in the investigator's
opinion, would preclude study treatment or informed consent

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior radiotherapy to the scalp, cranium, brain, or skull base
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT00895622      |      Link to official Clinicaltrials.gov listing
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