Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors
Overview
RATIONALE: Photodynamic therapy uses light and photosensitizing drugs to kill tumor cells and may be an effective treatment for refractory brain tumors. PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy using porfimer sodium in treating patients with refractory brain tumors, including astrocytoma, ependymoma, and medulloblastoma.
Full Title of Study: “Photodynamic Therapy For Childhood Brain Tumors, A Phase I Study”
Study Type
- Study Type: Interventional
- Study Design
- Primary Purpose: Treatment
Detailed Description
OBJECTIVES: – Determine the maximum tolerated dose of benzoporphyrin monoacid ring A in patients with refractory brain tumors undergoing cavitary photoillumination photodynamic therapy. – Determine the effect of this regimen on neurotoxicity, clinical state, imaging changes, and survival of these patients. OUTLINE: This is a dose-escalation study. Patients are stratified according to tumor location (posterior fossa tumors vs all other brain tumors). Patients receive benzoporphyrin monoacid ring A (BPD-MA) IV preoperatively. Approximately 3 hours after BPD-MA administration, patients undergo craniotomy with photoillumination of the tumor. Patients with tumors greater than 2 cm in diameter also undergo gross tumor resection. Cohorts of 3-6 patients receive escalating doses of BPD-MA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose immediately preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Three additional patients are treated at the MTD. Patients are followed at 4 and 6 weeks, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A minimum of 24 patients will be accrued for this study within 3 years.
Interventions
- Drug: verteporfin
- Procedure: conventional surgery
Participating in This Clinical Trial
DISEASE CHARACTERISTICS:
- Diagnosis of supratentorial or infratentorial brain tumor – Localized, non-disseminated – Primary tumor or solitary metastasis – Recurrent or progressive – Unresectable – Negative CSF – Must have failed standard therapy including radiotherapy – Measurable disease as evidenced by CT scan or MRI – Single or multiple masses accessible to light administration PATIENT CHARACTERISTICS: Age: – 3 to 70 Performance status: – Not specified Life expectancy: – At least 2 months Hematopoietic: – Absolute neutrophil count at least 1,000/mm3 – May transfuse platelets Hepatic: – PT and PTT normal Renal: – Not specified Other: – Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: – Not specified Chemotherapy: – At least 6 weeks since prior chemotherapy Endocrine therapy: – Not specified Radiotherapy: – See Disease Characteristics – No prior brachytherapy Surgery: – See Disease Characteristics Other: – No other concurrent antitumor therapy
Gender Eligibility: All
Minimum Age: 3 Years
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Medical College of Wisconsin
- Overall Official(s)
- Harry T. Whelan, MD, Study Chair, Medical College of Wisconsin
References
Schmidt MH, Bajic DM, Reichert KW 2nd, Martin TS, Meyer GA, Whelan HT. Light-emitting diodes as a light source for intraoperative photodynamic therapy. Neurosurgery. 1996 Mar;38(3):552-6; discussion 556-7. doi: 10.1097/00006123-199603000-00025.
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.