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Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors Clinical research trials and Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors. Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors  Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors
Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors
For Condition: adult brain tumor,brain metastases,childhood brain stem glioma,childhood brain tumor,childhood cerebellar astrocytoma,childhood visual pathway and hypothalamic glioma
Status: Recruiting
Sponsor(s): Medical College of Wisconsin ,
Synopsis: RATIONALE: Photodynamic therapy uses light and photosensitizing drugs to kill tumor cells and may be an effective treatment for refractory brain tumors. PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy using porfimer sodium in treating patients who have refractory brain tumors, including astrocytoma, ependymoma, and medulloblastoma.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 3 Years/70 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of supratentorial or infratentorial brain tumor - Localized, non-disseminated - Primary 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HarryWhelan, Study Chair, Medical College of Wisconsin
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting Harry Whelan 414-266-7545
Children's Hospital of Wisconsin *Recruiting*
Milwaukee, Wisconsin, 53201
United States
Recruiting Bruce Kaufman 414-266-2000
Additional Information:
Study ID Numbers: CDR0000064165; MCW-7594,MCW-CHW-511,MCW-CHW-9411,NCI-V95-0652
Study Start Date:
Record last reviewed: July 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002647
Other Childhood Brain Stem Glioma Studies:
1. Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors
2. Tipifarnib in Treating Young Patients With Recurrent, Refractory, or Progressive High-Grade Glioma, Medulloblastoma, Primitive Neuroectodermal Tumor, or Brain Stem Glioma
3. Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Malignant Glioma
Related Studies:
Other childhood brain stem glioma Clinical Trials
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Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors
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