Metastatic brain tumor Metastatic brain tumor, Recurrent metastatic brain tumor, Photodynamic therapy, local recurrence
Conditions
Interventions
Tumor resection combined with photodynamic therapy using talaporfin sodium and a semiconductor laser device for newly diagnosed and recurrent metastatic brain tumor after stereotactic irradiation
Sponsors
Ohno Makoto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Both cohort A and B 1.A lesion with the largest diameter planned for surgical resection is located in the cerebrum or cerebellum, as confirmed by preoperative gadolinium-enhanced MRI. 2.Preoperative Karnofsky Performance Status (KPS) score of 60 or higher. 3.Gross total resection of the largest lesion is deemed feasible. 4.No evidence of rapid progression of extracranial lesions. 5.Age between 18 and 85 years at the time of enrollment. 6.Adequate function of major organs. 7.Written informed consent obtained from the patient (signature by a surrogate is permitted if the patient's intent can be confirmed). Specific to Cohort A: 1.Presence of four or fewer metastatic lesions on preoperative gadolinium-enhanced MRI. 2.One lesion with a maximum diameter exceeding 2 cm planned for surgical resection, with all other lesions measuring 2 cm or less on preoperative gadolinium-enhanced MRI. 3.Histologica or radiological diagnosis of the primary tumors as one of the following: non-small cell lung cancer, breast cancer, colorectal cancer, renal cell carcinoma, ovarian cancer, cervical cancer, endometrial cancer, gastric cancer, or esophageal cancer. 4.No prior history of intracranial radiotherapy or craniotomy for tumor resection. Specific to Cohort B: 1.One lesion with a maximum diameter exceeding 2 cm planned for surgical resection, as confirmed by preoperative gadolinium-enhanced MRI. 2.History of stereotactic irradiation (STI) to the lesion planned for surgical resection. 3.The lesion planned for surgical resection shows uptake of 18F-fluorodeoxyglucose (FDG) on preoperative positron emission tomography (PET). 4.No restrictions on histological type of the primary tumor. 5.No restrictions on the number of metastatic lesions.
Exclusion criteria
Exclusion criteria: 1) Patients with a history of hypersensitivity to talaporfin sodium. 2) Patients with porphyria. 3) Patients with leptomeningeal carcinomatosis. 4) Patients with uncontrolled hypertension (defined as systolic blood pressure >160 mmHg andor diastolic blood pressure >100 mmHg). 5) Patients with a history of hypertensive crisis or hypertensive encephalopathy. 6) Patients with congestive heart failure of New York Heart Association (NYHA) Class II or higher. 7) Patients with active infections requiring systemic therapy. 8) Patients with diabetes mellitus requiring continuous insulin therapy or with poorly controlled diabetes. 9) Patients receiving continuous systemic corticosteroid therapy (oral or intravenous) at a dose of more than 50 mg/day (prednisolone equivalent) for any underlying condition. 10) Patients with any of the following medical histories within 6 months prior to enrollment: Myocardial infarction or unstable angina. Stroke or transient ischemic attack. Serious vascular disorders (aortic aneurysm requiring surgical intervention or peripheral arterial thrombosis). Abdominal wall fistula or gastrointestinal perforation. Intracranial abscess. 11) Pregnant or breastfeeding women; women who are pregnant, may be pregnant, or intend to become pregnant; and men whose partners are planning to become pregnant. 12) Patients with known allergy to gadolinium contrast agents. 13) Any other condition that, in the investigator judgment, would make the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month local recurrence rate at the surgical site | — |
Secondary
| Measure | Time frame |
|---|---|
| Intratumoral concentration of talaporfin sodium Overall survival Time to leptomeningeal dissemination Time to distant recurrence Intracranial progression-free survival Proportion of patients without deterioration of performance status at 6 months after enrollment Proportion of patients without deterioration of Mini-Mental State Examination (MMSE) score at 6 months after enrollment Incidence of adverse events Incidence of serious adverse events | — |
Contacts
Public ContactDaisuke Kawauchi
National Cancer Center Hospital
Outcome results
None listed