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

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ClinicalTrials.gov Identifier: NCT00002647
Recruitment Status : Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : January 27, 2003
Last Update Posted : September 20, 2013
Sponsor:
Information provided by:

Study Description
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.


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

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Primary Purpose: Treatment
Official Title: Photodynamic Therapy For Childhood Brain Tumors, A Phase I Study
Study Start Date : May 1994


Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
ClinicalTrials.gov Identifier: NCT00002647     History of Changes
Other Study ID Numbers: CDR0000064165
MCW-7594
MCW-CHW-511
MCW-CHW-9411
NCI-V95-0652
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: June 2009

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
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplastic Processes
Pathologic Processes
Verteporfin
Photosensitizing Agents
Dermatologic Agents