Clinical Trial Details
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NCT01637753 : Safety and Efficacy Study of Intracranially Implanted Carmustine to Treat Recurrent Malignant Glioma
AgesMin: 18 Years Max: 70 Years
Inclusion Criteria:

- Patients must be 18 to 70 years old, signed ICF;

- At least 4 weeks after previous chemotherapy (6 weeks since nitrosoureas);

- KPS ? 60;

- Unilateral, Supratentorial, solitary lesion and not crossing the midline(exclude
patients with little tumors near the resectable tumor even if investigators think
they are single lesions)

- No obvious important organ dysfunction: Blood routine: White blood cell (WBC) ?
4.0×109/L, Absolute neutrophil count (ANC)? 1.5×109/L, Platelets? 100×109/L,
Hemoglobin? 90 g/L; Hepatic function:Serum total bilirubin ?1.5 times upper limit of
laboratory normal; Aspartate aminotransferase (AST) and/or Alanine aminotransferase
(ALT)?2.5 times upper limit of laboratory normal; Renal function:Serum creatinine
?1.5 times upper limit of laboratory normal;

- Not Pregnant or lactating for women of childbearing potential.

Exclusion Criteria:

- Tumor located at ventricular system, Open ventricle tumor cavity postoperatively;

- Concomitant with other life-threatening diseases and with life expectancy ?3 months;

- Allergic to nitrosourea drugs;

- With history of intracranial radiotherapy or implant chemotherapy;

- With serious cardiac, pulmonary, hepatic and renal dysfunction, poor glycemic

- Investigators thought unsuitable for enrollment.
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