Photodynamic Therapy For Childhood Brain Tumors, A Phase I Study
- 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
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.
Primary Purpose: Treatment
Harry T. Whelan, MD
Medical College of Wisconsin
|Medical College of Wisconsin Cancer Center||Milwaukee, Wisconsin 53226|
|Midwest Children's Cancer Center at Children's Hospital of Wisconsin||Milwaukee, Wisconsin 53226|