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:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT01308632
Eligibility Criteria:
Inclusion Criteria:
1. Patients \> 18 years old
2. Histological confirmed GB at first relapse, assessed by MRI scan, after surgical resection or biopsy, radiotherapy, and first-line chemotherapy with TMZ. A TMZ treatment duration of at least 3 months is required. Previous chemotherapy with CPT-11 is not allowed.
3. Karnofsky performance status ≥ 70.
4. ANC ≥ 1500/ μl, platelet count ≥ 100000/ μl, haemoglobin \> 10 g/dl, serum creatinine and total bilirubin \< 1.5 times the upper limit of laboratory normal, transaminases \< 3.0 times the upper limit of laboratory normal.
5. Stable or descending corticosteroid dose ≥ 72 hours before baseline MRI and study treatment.
6. Life expectancy greater than 3 months
7. Written informed consent.
Exclusion Criteria:
1. Pregnancy or breastfeeding.
2. Neurological impairment that precludes comprehension or treatment administration
3. Vomiting or other condition that interfere with oral administration of TMZ
4. Previous or concurrent malignancy, excluding basal cell carcinomas or in situ cervical cancer.
5. Concurrent disease that could interfere with treatment
6. Concurrent treatment with enzyme-inducing drugs. Patients under enzyme-inducing anticonvulsants should discontinue treatment at least one week before study treatment and begin a new anti-epileptic treatment with non enzyme-inducing drugs if indicated.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01308632
Study Brief:
Protocol Section:
NCT01308632