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Surgery, Radiation Therapy, and Chemotherapy With or Without Photodynamic Therapy in Treating Patients With Newly Diagnosed or Recurrent Malignant Supratentorial Gliomas Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Surgery, Radiation Therapy, and Chemotherapy With or Without Photodynamic Therapy in Treating Patients With Newly Diagnosed or Recurrent Malignant Supratentorial Gliomas conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Surgery, Radiation Therapy, and Chemotherapy With or Without Photodynamic Therapy in Treating Patients With Newly Diagnosed or Recurrent Malignant Supratentorial Gliomas Clinical research trials and Surgery, Radiation Therapy, and Chemotherapy With or Without Photodynamic Therapy in Treating Patients With Newly Diagnosed or Recurrent Malignant Supratentorial Gliomas healthcare trials occur in a lot of of places throughout 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 potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Surgery, Radiation Therapy, and Chemotherapy With or Without Photodynamic Therapy in Treating Patients With Newly Diagnosed or Recurrent Malignant Supratentorial Gliomas. Surgery, Radiation Therapy, and Chemotherapy With or Without Photodynamic Therapy in Treating Patients With Newly Diagnosed or Recurrent Malignant Supratentorial Gliomas Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Surgery, Radiation Therapy, and Chemotherapy With or Without Photodynamic Therapy in Treating Patients With Newly Diagnosed or Recurrent Malignant Supratentorial Gliomas clinical trial. Participants typically obtain the most effective healthcare available for their Surgery, Radiation Therapy, and Chemotherapy With or Without Photodynamic Therapy in Treating Patients With Newly Diagnosed or Recurrent Malignant Supratentorial Gliomas condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Surgery, Radiation Therapy, and Chemotherapy With or Without Photodynamic Therapy in Treating Patients With Newly Diagnosed or Recurrent Malignant Supratentorial Gliomas  Surgery, Radiation Therapy, and Chemotherapy With or Without Photodynamic Therapy in Treating Patients With Newly Diagnosed or Recurrent Malignant Supratentorial Gliomas
Surgery, Radiation Therapy, and Chemotherapy With or Without Photodynamic Therapy in Treating Patients With Newly Diagnosed or Recurrent Malignant Supratentorial Gliomas
For Condition: adult glioblastoma multiforme,adult anaplastic astrocytoma,recurrent adult brain tumor
Status: No longer recruiting
Sponsor(s): HealthONE Alliance ,
Synopsis: RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. It is not yet known if the addition of photodynamic therapy to combined therapy with surgery, radiation therapy, and chemotherapy is more effective than combined therapy alone for supratentorial gliomas. PURPOSE: Randomized phase III trial to study the effectiveness of surgery, radiation therapy, and chemotherapy with or without photodynamic therapy in treating patients who have newly diagnosed or recurrent malignant supratentorial gliomas.
Details: OBJECTIVES: - Determine whether the addition of photodynamic therapy to standard brain tumor care (surgical resection, postoperative radiotherapy, and chemotherapy) will result in a significant prolongation of time to recurrence and survival in newly diagnosed malignant supratentorial gliomas. - 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, two part study. Patients are stratified according to clinical center. Newly diagnosed patients (Study 1) - Patients are randomized to receive either high light dose photodynamic therapy (arm I) or no photodynamic therapy (arm II): - Arm I: Patients receive porfimer sodium (Photofrin) IV one day prior to surgery. Craniotomy and tumor resection are performed. Upon completion of resection, patients undergo intracavitary photoillumination with a high light dose. - Craniotomy and tumor resection are performed. Postoperatively, all patients receive external beam radiotherapy 5 days per week for 5-6 weeks. After completing radiotherapy, patients receive nitrosourea (carmustine or lomustine) chemotherapy. Recurrent tumor patients (Study 2) - Patients receive Photofrin IV one day prior to surgery. Craniotomy and tumor resection are performed. - Arm I: Patients receive high dose light therapy during surgery. - Patients receive low dose light therapy during surgery. Patients receive chemotherapy with procarbazine for 28 days beginning 2-4 weeks after surgery. Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity. Patients are followed on both studies at 4 weeks postsurgery, then every 3 months until death or for 1 year after study closure. PROJECTED ACCRUAL: A minimum of 150 patients with newly diagnosed tumor will be accrued for this study within 4 years (Study 1). A maximum of 120 patients with recurrent disease will be accrued within 4.5 years (Study 2)
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed newly diagnosed or recurrent supratentorial glioblastoma or malignant astrocytoma - Grade 3 or 4 astrocytoma as defined by the Daumas-Duport classification - Suitable for radical resection on the basis of imaging studies - Patients with recurrent disease must have failed surgery and radiotherapy PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% for newly diagnosed tumor - Karnofsky 70-100% for recurrent tumor Life expectancy: - At least 3 months Hematopoietic: - Recurrent tumor: - WBC at least 2,000/mm^3 - Platelet count at least 80,000/mm^3 Hepatic: - Recurrent tumor: - 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 PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - No prior cranial radiotherapy for newly diagnosed tumor Surgery: - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FredHetzel, Study Chair, HealthONE Alliance
St. Michael's Hospital-Annex
Toronto, Ontario, M5B 1A6
Canada
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Rocky Mountain Neurological Associates
Englewood, Colorado, 80110
United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
United States
Additional Information:
Study ID Numbers: CDR0000066927; HEALTHONE-43892,HEALTHONE-1A,HEALTHONE-CA43892,RPCI-DS-9802,NCI-V99-1525
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003788
Other Adult Anaplastic Astrocytoma Studies:
1. Carmustine Plus O6-benzylguanine in Treating Patients With Recurrent or Progressive Glioma
2. Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma
3. Atrasentan in Treating Patients With Progressive or Recurrent Malignant Glioma
4. Motexafin Gadolinium in Treating Patients With Glioblastoma Multiforme Who Are Undergoing Radiation Therapy to the Brain
5. Gene Therapy in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme
Related Studies:
Other adult anaplastic astrocytoma Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
Surgery, Radiation Therapy, and Chemotherapy With or Without Photodynamic Therapy in Treating Patients With Newly Diagnosed or Recurrent Malignant Supratentorial Gliomas
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