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
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002647
First received: November 1, 1999
Last updated: September 19, 2013
Last verified: June 2009
  Purpose

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:

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

Ages Eligible for Study:   3 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002647

Locations
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
Investigators
Study Chair: Harry T. Whelan, MD Medical College of Wisconsin
  More Information

Additional Information:
Publications:
ClinicalTrials.gov 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: September 19, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent childhood pilocytic astrocytoma
adult pilocytic astrocytoma
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 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

Additional relevant MeSH terms:
Neoplasm Metastasis
Brain Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 22, 2014