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Photodynamic Therapy in Treating Patients With Recurrent Malignant Supratentorial Gliomas Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Photodynamic Therapy in Treating Patients With Recurrent Malignant Supratentorial Gliomas conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Photodynamic Therapy in Treating Patients With Recurrent Malignant Supratentorial Gliomas Clinical research trials and Photodynamic Therapy in Treating Patients With Recurrent Malignant Supratentorial Gliomas medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Photodynamic Therapy in Treating Patients With Recurrent Malignant Supratentorial Gliomas. Photodynamic Therapy in Treating Patients With Recurrent Malignant Supratentorial Gliomas Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Photodynamic Therapy in Treating Patients With Recurrent Malignant Supratentorial Gliomas clinical trial. Subjects often receive the most expert healthcare possible for their Photodynamic Therapy in Treating Patients With Recurrent Malignant Supratentorial Gliomas condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Photodynamic Therapy in Treating Patients With Recurrent Malignant Supratentorial Gliomas  Photodynamic Therapy in Treating Patients With Recurrent Malignant Supratentorial Gliomas
Photodynamic Therapy in Treating Patients With Recurrent Malignant Supratentorial Gliomas
For Condition: adult glioblastoma multiforme,recurrent adult brain tumor,adult anaplastic astrocytoma
Status: Recruiting
Sponsor(s): Roswell Park Cancer Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photodynamic therapy using porfimer sodium may be effective in treating patients with recurrentmalignantsupratentorialgliomas. It is not yet known whether high-dose photodynamic therapy is more effective than low-dose photodynamic therapy in treating recurrent malignant supratentorial gliomas. PURPOSE: Randomizedphase III trial to compare the effectiveness of high-dose photodynamic therapy with that of low-dose photodynamic therapy in treating patients who have recurrent malignant supratentorial gliomas that have not responded to previous surgery and radiation therapy.
Details: OBJECTIVES: - Compare the effect of high or low light dose photodynamic therapy on survival of patients with recurrent malignant supratentorial gliomas. OUTLINE: This is a randomized, multicenter study. Patients receive porfimer sodium (Photofrin) by intravenous injection one day prior to surgery. Craniotomy and tumor resection are performed. Patients are randomized to receive high or low dose light therapy during surgery using a laser and balloon delivery device. Patients receive chemotherapy with procarbazine 2-4 weeks after surgery for 28 days, followed by 28 days of rest. Courses are repeated in the absence of disease progression and unacceptable toxicity. Patients are followed at 4 weeks postsurgery, then every 3 months until death. PROJECTED ACCRUAL: This study will accrue a maximum of 120 patients within 4.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Biopsy proven recurrent malignant glioblastoma or malignant astrocytoma - Failed prior surgery and radiotherapy - Resectable tumor PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 70-100% Life expectancy: - At least 3 months Hematopoietic: - WBC at least 2000/mm^3 - Platelet count at least 80,000/mm^3 Hepatic: - PT/PTT no greater than 1.5 times upper limit of normal (ULN) - Bilirubin and LFTs less than 2 times ULN - Alkaline phosphatase no greater than 3 times ULN - GGT no greater than 3 times ULN Renal: - Creatinine no greater than 2 mg/dL Other: - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior procarbazine Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics Surgery: - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertFenstermaker, Study Chair, Roswell Park Cancer Institute
Western Pennsylvania Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15224
United States
Recruiting Robert Selker 412-578-4340
Rocky Mountain Neurological Associates *Recruiting*
Englewood, Colorado, 80110
United States
Recruiting Timothy Fullagar 303-788-4000
St. Michael's Hospital-Annex *Recruiting*
Toronto, Ontario, M5B 1A6
Canada
Recruiting Paul Muller 416-864-5590
Additional Information:
Study ID Numbers: CDR0000066753; RPCI-DS-9802,HEALTHONE-43892,NCI-G98-1484
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003660
Other Recurrent Adult Brain Tumor Studies:
1. Temozolomide and Carmustine in Treating Patients With Anaplastic Glioma
2. Surgery, Radiation Therapy, and Chemotherapy With or Without Photodynamic Therapy in Treating Patients With Newly Diagnosed or Recurrent Malignant Supratentorial Gliomas
3. Temozolomide in Treating Patients With Recurrent Malignant Glioma
4. Carmustine Wafers Plus Irinotecan in Treating Patients With Recurrent Supratentorial High Grade Gliomas
5. Radiolabeled Monoclonal Antibody in Treating Patients With Glioblastoma Multiforme or Anaplastic Astrocytoma
Related Studies:
Other recurrent adult brain tumor Clinical Trials
Other Colorado Clinical Trials
Other Englewood Clinical Trials
Photodynamic Therapy in Treating Patients With Recurrent Malignant Supratentorial Gliomas
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