Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT00045734
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed meningioma
* Benign, malignant, or atypical disease
* Neurofibromatosis (NF) type 1 or 2 allowed
* Hemangiopericytoma allowed
* Unequivocal evidence of tumor recurrence or progression by MRI or CT scan (on steroid dosage that is stable for at least 5 days)
* Evaluable residual disease by MRI or CT scan if previously treated with surgical resection for recurrent or progressive disease
* Newly diagnosed recurrent disease that requires surgical debulking allowed
* Prior standard external-beam radiotherapy, interstitial brachytherapy, or gamma-knife radiosurgery allowed provided disease has progressed since completion of therapy
* Patients who have had prior brachytherapy or stereotactic radiosurgery must have confirmation of true progressive disease rather than radiation necrosis based upon positron-emission tomography or thallium scanning, magnetic resonance spectroscopy, or surgical documentation
* Patients with a history of NF may have other stable Central Nervous System (CNS) tumors (e.g., schwannoma, acoustic neuroma, or ependymoma) provided those lesions have been stable in size for the past 6 months
* Performance status - Karnofsky 60-100%
* More than 8 weeks
* Absolute neutrophil count at least 2,000/mm\^3
* Platelet count at least 120,000/mm\^3
* Hemoglobin at least 10 g/dL (transfusions allowed)
* No bleeding disorders
* Bilirubin less than 2 times upper limit of normal (ULN)
* Serum glutamic oxaloacetic transaminase (SGOT) less than 2 times ULN
* Prothrombin Time (PT), Partial thromboplastin time (PTT), and International normalized Ratio (INR) no greater than 1.5 times ULN
* Creatinine less than 1.5 mg/dL
* Creatinine clearance at least 60 mL/min
* No deep venous or arterial thrombosis within the past 6 weeks
* No pulmonary embolism within the past 6 weeks
* No serious active infection
* No prior intracranial hemorrhage
* No concurrent disease that would obscure toxicity or dangerously alter drug metabolism
* No other malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix unless the patient is in complete remission and off all therapy for that disease for at least 3 years
* No other significant medical illness that would preclude study participation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for 3 months after study participation
* At least 1 week since prior interferon or thalidomide
* No concurrent immunotherapy
* Concurrent epoetin alfa allowed
* At least 4 weeks since prior cytotoxic chemotherapy
* At least 2 weeks since prior vincristine
* At least 6 weeks since prior nitrosoureas
* At least 3 weeks since prior hydroxyurea or procarbazine
* No concurrent chemotherapy
* At least 1 week since prior tamoxifen
* No concurrent hormonal therapy
* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy
* Recovered from prior surgery
* Recovered from all prior therapy
* At least 1 week since prior noncytotoxic therapy (e.g., isotretinoin) except radiosensitizers
* At least 2 weeks since prior drugs that affect hepatic metabolism
* At least 4 weeks since prior investigational agents
* No concurrent warfarin (heparin or low-molecular weight heparin allowed)
* No other concurrent investigational agents
* No concurrent acetaminophen of more than 500 mg/day
* No other concurrent anticancer therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00045734
Study Brief:
Protocol Section:
NCT00045734