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 @ 5:07 AM
Ignite Modification Date:
2025-12-25 @ 5:07 AM
NCT ID:
NCT00049127
Eligibility Criteria:
Inclusion Criteria:
* Study 1 Arm C:
* Currently on anticonvulsants which can induce cytochrome p450 (phenytoin, carbamazepine, barbiturates, primidone and if unsure contact study chair)
* =\< 2 prior chemotherapy regimens (with maximum of 1 prior chemotherapy regimen for recurrent disease)
* Study 2 Arms A and B:
* On or off anticonvulsants
* =\< 2 prior chemotherapy regimens (with maximum of 1 prior chemotherapy regimen for recurrent disease)
* Study 3 Arms D and E:
* On or off anticonvulsants
* \> 2 chemotherapy regimens or 2 prior chemotherapy regimens for progressive/recurrent disease
* All Arms:
* Histological confirmation of a grade 2-4 oligodendroglioma, or mixed oligoastrocytoma grade 2-4 containing oligodendrogliomatous component on central pathology review prior to study registration, and a diagnosis of recurrence; tissues from all available prior surgeries should be sent, in particular those from time of initial diagnosis
* Measurable or evaluable disease by magnetic resonance imaging (MRI) or computed tomography (CT) scan
* Fixed dose of corticosteroids (or no corticosteroids) for at least 1 week prior to the pre-study baseline scan
* Patients undergoing surgery for initial or progressive disease, must be at least 2 weeks from the date of surgery, must have recovered from the effects of their surgery, and must have unequivocal tumor growth on the pre-study baseline neuroimaging study as compared to the first post-operative scan, unless there is a separate lesion or residual disease compatible with tumor that is not within the surgical bed
* Unequivocal evidence of tumor progression by MRI or CT scan performed =\< 21days prior to study registration
* Must have failed surgery/radiotherapy (RT) and Temozolomide or nitrosourea based therapy
* \>= 12 weeks since the completion of RT
* Absolute neutrophil count (ANC) \>= 1500/mm\^3
* Platelets (PLT) \>= 100,000/mm\^3
* Hemoglobin (Hgb) \>= 9 g/dL
* Total bilirubin =\< 1.5 mg/dL
* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =\< 3 x upper limit of normal (ULN)
* Creatinine =\< 2.0 mg/dL
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
* \>= 6 weeks since the last day of nitrosourea-based chemotherapy prior to study entry
* \>= 4 weeks from any investigational agents prior to study entry
* \>= 4 weeks from other chemotherapy prior to study entry
* \>= 2 weeks from vincristine and biologic non-cytotoxic agents, e.g., tamoxifen, thalidomide, cis-retinoic acid, interferon, etc, prior to study entry
* Patients or designated individual(s) with durable medical power of attorney for the patient must be able to provide informed, written consent, and complete any required study questionnaire(s) within the specifications of this study
Exclusion Criteria:
* All Arms
* Receiving warfarin or heparin
* Received prior stereotactic radiosurgery, interstitial brachytherapy, or interstitial chemotherapy including carmustine (BCNU) wafers unless there is a separate lesion on MRI, which is not part of the previous treatment field
* Active uncontrolled infection
* History of myocardial infarction =\< 6 months or congestive heart failure (CHF) requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias; patients must have a New York Heart Association (NYHA) of class II or less; (NYHA class I: patients with no limitation of activities; they suffer no symptoms from ordinary activities; class II: patients with slight, mild limitation of activity; they are comfortable with rest or with mild exertion; class III: patients with marked limitation of activity; they are comfortable only at rest; class IV: patients who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest)
* Other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the interpretation of potential drug-induced toxicities
* Women of child-bearing potential, pregnant or nursing; such patients must have a negative pregnancy test (b-HCG) =\< 7 days prior to study registration
* Men or women of childbearing potential, not willing to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], surgical sterilization, subcutaneous implants, or abstinence, etc.); the efficacy of oral contraceptives may be decreased in patients who receive p450-inducing anticonvulsants; for these patients, use of a second mode of contraception is recommended; patients of childbearing potential must utilize effective contraception and avoid becoming pregnant or fathering a child for 6 months after completing study drug
* Other active malignancy, besides skin carcinomas (must not be melanoma)
* Concomitant serious immunocompromised status (other than that related to concomitant steroids); patients that are human immunodeficiency virus (HIV) positive are eligible, provided that there is no other reason for exclusion, based on the eligibility as outlined elsewhere in this section
* Significant intratumoral hemorrhage on baseline MRI or CT, or other history of significant intratumoral hemorrhage
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00049127
Study Brief:
Protocol Section:
NCT00049127