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Trial Title:
Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors
NCT ID:
NCT00002647
Condition:
Brain and Central Nervous System Tumors
Metastatic Cancer
Conditions: Official terms:
Brain Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Verteporfin
Conditions: Keywords:
recurrent adult brain tumor
tumors metastatic to brain
recurrent childhood brain stem glioma
recurrent childhood anaplastic astrocytoma
recurrent childhood anaplastic oligoastrocytoma
recurrent childhood anaplastic oligodendroglioma
recurrent childhood cerebellar astrocytoma
recurrent childhood cerebral astrocytoma
recurrent childhood diffuse astrocytoma
recurrent childhood fibrillary astrocytoma
recurrent childhood gemistocytic astrocytoma
recurrent childhood giant cell glioblastoma
recurrent childhood glioblastoma
recurrent childhood gliomatosis cerebri
recurrent childhood gliosarcoma
recurrent childhood oligodendroglioma
recurrent childhood pilocytic astrocytoma
recurrent childhood pilomyxoid astrocytoma
recurrent childhood pleomorphic xanthoastrocytoma
recurrent childhood protoplasmic astrocytoma
recurrent childhood subependymal giant cell astrocytoma
recurrent childhood visual pathway and hypothalamic glioma
recurrent childhood visual pathway glioma
recurrent childhood pineoblastoma
recurrent childhood supratentorial primitive neuroectodermal tumor
recurrent childhood medulloblastoma
recurrent childhood ependymoma
recurrent childhood brain tumor
adult anaplastic astrocytoma
adult anaplastic ependymoma
adult anaplastic meningioma
adult anaplastic oligodendroglioma
adult brain stem glioma
adult central nervous system germ cell tumor
adult choroid plexus tumor
adult craniopharyngioma
adult diffuse astrocytoma
adult ependymoblastoma
adult ependymoma
adult giant cell glioblastoma
adult glioblastoma
adult gliosarcoma
adult medulloblastoma
meningeal melanocytoma
adult meningeal hemangiopericytoma
adult oligodendroglioma
adult papillary meningioma
adult pilocytic astrocytoma
adult pineal gland astrocytoma
adult pineoblastoma
adult pineocytoma
adult subependymal giant cell astrocytoma
adult subependymoma
adult supratentorial primitive neuroectodermal tumor (PNET)
childhood grade I meningioma
childhood grade II meningioma
childhood grade III meningioma
adult grade III meningioma
childhood central nervous system germ cell tumor
childhood choroid plexus tumor
childhood craniopharyngioma
childhood infratentorial ependymoma
childhood supratentorial ependymoma
childhood low-grade cerebral astrocytoma
childhood high-grade cerebral astrocytoma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Unknown status
Study design:
Primary purpose:
Treatment
Intervention:
Intervention type:
Drug
Intervention name:
verteporfin
Intervention type:
Procedure
Intervention name:
conventional surgery
Summary:
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.
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.
Criteria for eligibility:
Criteria:
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:
All
Minimum age:
3 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Medical College of Wisconsin Cancer Center
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Office - Medical College of Wisconsin Cancer C
Phone:
414-805-4380
Facility:
Name:
Midwest Children's Cancer Center at Children's Hospital of Wisconsin
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bruce A. Kaufman, MD
Phone:
414-266-2000
Start date:
May 1994
Lead sponsor:
Agency:
Medical College of Wisconsin
Agency class:
Other
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00002647
