Clinical trial NCT00002647: Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors
Official title: Photodynamic Therapy For Childhood Brain Tumors, A Phase I Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Brain and Central Nervous System Tumors
Metastatic Cancer
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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 24
Sex: ALL
Minimum age (years): 3
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Cancer Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Midwest Children's Cancer Center at Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Harry T. Whelan, MD
role: STUDY_CHAIR
References:
citation: 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.