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| Sponsored by: |
Medical College of Wisconsin |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002647 |
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 |
Drug: verteporfin Procedure: conventional surgery |
Phase I |
| MedlinePlus related topics: | Brain Cancer Cancer Childhood Brain Tumors |
| ChemIDplus related topics: | Porfimer sodium Dihematoporphyrin ether Trioxsalen Verteporfin |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Photodynamic Therapy For Childhood Brain Tumors, A Phase I Study |
| Estimated Enrollment: | 24 |
| Study Start Date: | May 1994 |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
Diagnosis of supratentorial or infratentorial brain tumor
Measurable disease as evidenced by CT scan or MRI
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and 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 | |||||
| Medical College of Wisconsin |
| Study Chair: | Harry T. Whelan, MD | Medical College of Wisconsin |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000064165, MCW-7594, MCW-CHW-511, MCW-CHW-9411, NCI-V95-0652 |
| First Received: | November 1, 1999 |
| Last Updated: | September 10, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002647 |
| Health Authority: | Unspecified |
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