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A Study of a Retroviral Replicating Vector Combined With a Prodrug Administered to Patients With Recurrent Malignant Glioma
Bu Faz 1 çalışması, tekrarlayan kötü huylu beyin tümörü olan glioma (malignant glioma) hastalarında, tümör hücrelerine gen aktaran bir tedaviyi (Toca 511 vektörü) öncül ilaç Toca FC ile birlikte incelemektedir. Çalışmaya, 18 yaş ve üzeri, ameliyatla tümörü tamamen çıkarılamayan yüksek dereceli glioma hastaları katılmıştır. Faz 1 aşamasında yürütülmüş ve tamamlanmıştır.
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Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * at least 18 years of age * for intratumoral cohorts, supratentorial HGG (WHO grade III or IV) * technically unresectable HGG * initial definitive therapy such as surgery with or without adjuvant radiation * subject elected not to undergo treatment with Gliadel wafer * if receiving corticosteroids, dose is stable or decreasing for past 7 days * KPS: at least 70 * absolute neutrophil count \> 1500/mm\^3 * absolute lymphocyte count \> 500/mm\^3 * platelet count \> 100,000/mm\^3 * hemoglobin \> 10 g/dL * for intratumoral cohort, coagulation profile favorable to surgery * estimated glomerular filtration rate \> 50 mL/min * ALT \< 3 times ULN and bilirubin \< 1.5 mg/dL * negative serum pregnancy test Exclusion Criteria: * cytotoxic therapy within the past 4 weeks (6 weeks for BCNU/CCNU) * more than 2 recurrences including present recurrence * Gliadel wafer or wafers implanted within the past 8 weeks * taking more than 8 mg of dexamethasone per day * for intratumoral cohorts, injection of tumor would require violation of ventricular system * any infection requiring antibiotic, anticoagulant, or antiplatelet agents within the past 4 weeks * for intratumoral cohort, bleeding diathesis or use of anticoagulants/antiplatelet agents that cannot be stopped * allergy or intolerance to 5-FC * HIV positive * g.i. condition that would prevent ingestion or absorption of 5-FC * any investigational treatment within the past 30 days * pregnant or breast feeding * received Avastin * history of prior malignancy, excluding basal or squamous cell carcinoma of the skin, with an expected survival of less than 5 years.