Microsurgical Resection Combined With Photodynamic Therapy for Recurrent Glioblastoma

Korábbi kezelés

• Prior or concurrent malignancy at other sites, unless disease-free for >= 3 years
• Contraindications to surgery
• Treatment with any investigational drug within 30 days before study entry
• Prior allogeneic tissue or organ transplantation

Más betegség

• History of allergy to photosensitizers or hematoporphyrin
• Porphyria or soy allergy
• Other uncontrolled active infection
• Psychiatric disease or other conditions (e.g., uncontrolled cardiac or pulmonary disease, diabetes) precluding compliance with study treatment and monitoring
• HIV-positive or AIDS-related disease
• Any other condition judged unsuitable for enrollment by the investigator

Laborértékek

• Severe renal or hepatic impairment (bilirubin > 1.5 x ULN, alkaline phosphatase and AST > 2.5 x ULN, creatinine clearance < 30 mL/min)

Egyéb

• KPS score < 70
• Pregnant or lactating women
• Poor compliance or inability to follow skin photosensitivity precautions
• Contraindications to magnetic resonance imaging
• Follow-up impossible for psychological, family, social, or geographical reasons
• Lack of legal capacity (deprived of liberty or under guardianship)
• Refusal to participate or to provide consent

• Age 18-65 years, any sex
• KPS score >= 70 and ECOG performance status 0-2
• Patient and family members willing and able to provide written informed consent
• Histopathologically confirmed glioblastoma (WHO grade IV) that has progressed or recurred after standard radiotherapy and chemotherapy, based on radiological evidence of measurable disease
• More than 3 months since completion of brain radiotherapy
• Hospitalized for recurrence/progression with a sizable lesion causing related symptoms and/or mass effect, for which gross-total or subtotal resection is considered feasible at reoperation
• No concomitant malignancy, severe autoimmune disease or congenital immunodeficiency, severe active infection, cranial nerve disorder, or psychiatric disease
• Life expectancy greater than 12 weeks
• Cardiac function: essentially normal electrocardiogram, stable hemodynamics, left ventricular ejection fraction > 55%
• White blood cell count > 3.5 x 10\^9/L, platelet count > 100 x 10\^9/L, absolute neutrophil count > 1.5 x 10\^9/L, hemoglobin > 90 g/L
• ALT and AST < 2.5 x upper limit of normal (< 5 x ULN if hepatic impairment mainly due to tumor infiltration), total bilirubin < 1.5 x ULN, serum creatinine < 1 x ULN
• INR or prothrombin time < 1.5 x ULN and APTT < 1.5 x ULN (for patients on anticoagulation, PT/PTT within the expected therapeutic range)
• Negative for HIV antibody, Treponema pallidum antibody, HBsAg, HCV antibody, and EBV-DNA
• Female subjects must use effective contraception throughout the study, with negative serum or urine pregnancy test at screening and during the study
• Able to attend regular follow-up visits at the study institution throughout the trial
• Expected benefit of participation judged to outweigh the risks by the investigators