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Photodynamic Therapy For Childhood Brain Tumors, A Phase I Study


Phase 1
3 Years
70 Years
Open (Enrolling)
Both
Brain and Central Nervous System Tumors, Metastatic Cancer

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Trial Information

Photodynamic Therapy For Childhood Brain Tumors, A Phase I Study


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Harry T. Whelan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Medical College of Wisconsin

Authority:

Unspecified

Study ID:

CDR0000064165

NCT ID:

NCT00002647

Start Date:

May 1994

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Metastatic Cancer
  • 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
  • Brain Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Astrocytoma

Name

Location
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226
Midwest Children's Cancer Center at Children's Hospital of Wisconsin Milwaukee, Wisconsin  53226