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 @ 2:14 AM
Ignite Modification Date:
2025-12-25 @ 2:14 AM
NCT ID:
NCT00424060
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed glioblastoma
* Presence of oligodendroglial elements allowed provided they make up \< 25% of tumor
* Measurable disease, defined as ≥ 1 bidimensionally measurable target lesion with a largest diameter of ≥ 2 cm by MRI within the past 2 weeks
* Recurrent disease
* Documented by MRI after failing prior therapy (usually standard radiotherapy with concurrent and maintenance temozolomide)
* Subsequent histologic confirmation of recurrence required for patients who received prior high-dose radiotherapy (\> 65 Gy), stereotactic radiosurgery, or internal radiotherapy
* Multifocal disease that is not amenable to radiotherapy allowed provided the patient received no more than 1 line of prior chemotherapy
PATIENT CHARACTERISTICS:
* WHO performance status 0-2
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Bilirubin \< 1.5 times upper limit of normal (ULN)
* AST and ALT \< 2.5 times ULN
* Alkaline phosphatase \< 2.5 times ULN
* Creatinine \< 1.5 times ULN
* Clinically normal cardiac function
* No ischemic heart disease within the past 12 months
* Stable ischemic heart disease (e.g., treated angina that is stable under appropriate therapy) allowed
* No New York Heart Association class III or IV cardiac insufficiency
* No unstable angina
* No arrhythmia
* No psychological, familial, sociological, or geographical factors that would preclude study compliance
* No other malignancy except cone-biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer
* Not pregnant or nursing
* Negative pregnancy test
* Fertile female patients must use effective contraception during and for 3 months after completion of study treatment
* Fertile male patients must use effective contraception during and for 6 months after completion of study treatment
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
* More than 3 months since prior radiotherapy to the brain
* More than 3 months since prior surgery for recurrent primary brain tumor unless 1 of the following criteria are met:
* Measurable residual disease documented by immediate (within 72 hours) postoperative imaging
* Evidence of a progressive and measurable target lesion found at postoperative follow-up
* Presence of a second measurable target lesion outside the surgical area
* Prior adjuvant temozolomide as first-line therapy allowed
* No prior chemotherapy for recurrent glioblastoma
* One prior chemotherapy regimen given as adjuvant therapy allowed
* Concurrent corticosteroids allowed provided dose is stable or decreasing for ≥ 1 week
* No concurrent phenytoin, carbamazepine, or phenobarbital
* No concurrent Hypericum perforatum (St. John's wort)
* No concurrent enzyme-inducing antiepileptic drugs (EIAEDs)
* Patients on EIAEDs should have been switched to non-EIAEDs with a wash-out period of ≥ 1 month
* No other concurrent anticancer agents (except alternative or homeopathic medicine)
* No other concurrent investigational treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00424060
Study Brief:
Protocol Section:
NCT00424060