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| Sponsor: | 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 Metastatic Cancer |
Drug: verteporfin Procedure: conventional surgery |
Phase I |
| 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 | |
| Study Chair: | Harry T. Whelan, MD | Medical College of Wisconsin |
More Information
| Study ID Numbers: | CDR0000064165, MCW-7594, MCW-CHW-511, MCW-CHW-9411, NCI-V95-0652 |
| Study First Received: | November 1, 1999 |
| Last Updated: | August 25, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002647 History of Changes |
| Health Authority: | Unspecified |
|
recurrent adult brain tumor tumors metastatic to brain recurrent childhood brain stem glioma recurrent childhood supratentorial primitive neuroectodermal tumor recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma recurrent childhood medulloblastoma recurrent childhood visual pathway and hypothalamic glioma recurrent childhood ependymoma adult anaplastic astrocytoma adult anaplastic ependymoma adult anaplastic meningioma adult anaplastic oligodendroglioma adult brain stem glioma adult central nervous system germ cell tumor |
adult choroid plexus tumor adult craniopharyngioma adult diffuse astrocytoma adult ependymoblastoma adult ependymoma adult giant cell glioblastoma adult glioblastoma adult gliosarcoma adult medulloblastoma adult melanocytic lesion adult meningeal hemangiopericytoma adult oligodendroglioma adult papillary meningioma adult pilocytic astrocytoma adult pineal gland astrocytoma |
|
Neoplasms, Nerve Tissue Physiological Effects of Drugs Central Nervous System Neoplasms Brain Diseases Neoplastic Processes Pathologic Processes Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Neoplasm Metastasis Glioma Dermatologic Agents Nervous System Neoplasms |
Neoplasms by Histologic Type Astrocytoma Nervous System Diseases Verteporfin Central Nervous System Diseases Pharmacologic Actions Brain Neoplasms Neuroectodermal Tumors Neoplasms Photosensitizing Agents Radiation-Sensitizing Agents Neoplasms, Neuroepithelial Neoplasms, Glandular and Epithelial |
