Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors

Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).   Recruitment status was  Recruiting

First Received on November 1, 1999.  
Last Updated on January 19, 2012  
History of Changes
Sponsor: Medical College of Wisconsin
Information provided by: National Cancer Institute (NCI) Identifier: NCT00002647

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.

Condition Intervention Phase
Brain and Central Nervous System Tumors
Metastatic Cancer
Drug: verteporfin
Procedure: conventional surgery
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Photodynamic Therapy For Childhood Brain Tumors, A Phase I Study

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 24
Study Start Date: May 1994

Detailed Description:


  • 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.


Ages Eligible for Study:   3 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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



  • 3 to 70

Performance status:

  • Not specified

Life expectancy:

  • At least 2 months


  • Absolute neutrophil count at least 1,000/mm3
  • May transfuse platelets


  • PT and PTT normal


  • Not specified


  • Not pregnant


Biologic therapy:

  • Not specified


  • At least 6 weeks since prior chemotherapy

Endocrine therapy:

  • Not specified


  • See Disease Characteristics
  • No prior brachytherapy


  • See Disease Characteristics


  • No other concurrent antitumor therapy
  Contacts and Locations

Please refer to this study by its identifier: NCT00002647

United States, Wisconsin
Medical College of Wisconsin Cancer Center Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Clinical Trials Office – Medical College of Wisconsin Cancer C     414-805-4380        
Midwest Children’s Cancer Center at Children’s Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Bruce A. Kaufman, MD     414-266-2000        
Sponsors and Collaborators
Medical College of Wisconsin
Study Chair: Harry T. Whelan, MD Medical College of Wisconsin
  More Information

Additional Information:

Publications: Identifier: NCT00002647    
History of Changes
Other Study ID Numbers: CDR0000064165, MCW-7594, MCW-CHW-511, MCW-CHW-9411, NCI-V95-0652
Study First Received: November 1, 1999
Last Updated: January 19, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Brain Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplastic Processes
Pathologic Processes
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses processed this record on August 21, 2012

Leave a Reply

You can use these HTML tags

<a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <s> <strike> <strong>




six − two =