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Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors
This study is currently recruiting participants.
Study NCT00002647   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: August 25, 2009   History of Changes

November 1, 1999
August 25, 2009
May 1994
 
 
 
Complete list of historical versions of study NCT00002647 on ClinicalTrials.gov Archive Site
 
 
 
Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors
Photodynamic Therapy For Childhood Brain Tumors, A Phase I Study

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.

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.

Phase I
Interventional
Treatment
  • Brain and Central Nervous System Tumors
  • Metastatic Cancer
  • Drug: verteporfin
  • Procedure: conventional surgery
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
24
 
 

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
Both
3 Years to 70 Years
No
 
United States
 
NCT00002647
 
CDR0000064165, MCW-7594, MCW-CHW-511, MCW-CHW-9411, NCI-V95-0652
Medical College of Wisconsin
 
Study Chair: Harry T. Whelan, MD Medical College of Wisconsin
National Cancer Institute (NCI)
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP