|
Carmustine in Treating Patients With Recurrent Malignant Glioma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Carmustine in Treating Patients With Recurrent Malignant Glioma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Carmustine in Treating Patients With Recurrent Malignant Glioma Clinical research trials and Carmustine in Treating Patients With Recurrent Malignant Glioma healthcare trials occur in a lot of 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 does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Carmustine in Treating Patients With Recurrent Malignant Glioma. Carmustine in Treating Patients With Recurrent Malignant Glioma Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Carmustine in Treating Patients With Recurrent Malignant Glioma clinical trial. Test subjects typically receive the most effective healthcare possible for their Carmustine in Treating Patients With Recurrent Malignant Glioma condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Carmustine in Treating Patients With Recurrent Malignant Glioma  Carmustine in Treating Patients With Recurrent Malignant Glioma
Carmustine in Treating Patients With Recurrent Malignant Glioma
For Condition: adult ependymoblastoma,adult glioblastoma multiforme,Mixed Gliomas,adult anaplastic oligodendroglioma,recurrent adult brain tumor,adult anaplastic astrocytoma,adult malignant ependymoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of carmustine in treating patients who are undergoing surgery for recurrent malignant glioma.
Details: OBJECTIVES: - Determine the safety of polifeprosan 20 with carmustine implant (GLIADEL) in patients undergoing surgery for recurrent malignant glioma. OUTLINE: This is a dose escalation study. All patients undergo maximal tumor resection. At the time of surgery, groups of 6 patients receive up to 8 polifeprosan 20 wafers containing increasing doses of carmustine implanted into the resection cavity. Patients with an intraoperative diagnosis other than glioblastoma multiforme or anaplastic astrocytoma do not receive wafer implantation, and are removed from study. Patients are followed 3, 6, and 12 months after implantation. PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Pathologically confirmed recurrent malignant glioma for which surgery is indicated - Unilateral, supratentorial, solitary lesion at least 1.0 cm in diameter on contrast-enhanced CT or MRI PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - At least 8 weeks Hematopoietic: - WBC at least 3,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin, AST, ALT, and alkaline phosphatase less than 2.5 times normal Renal: - Creatinine less than 1.5 times normal - BUN less than 2.5 times normal - Protein no greater than 3 g/dL - No gross hematuria Other: - No hypersensitivity to nitrosoureas - Not pregnant - Fertile patients must use effective contraception - No concurrent life threatening disease PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent immunotherapy during first 8 weeks of study Chemotherapy: - At least 4 weeks since chemotherapy (6 weeks since nitrosoureas) - No concurrent chemotherapy during first 8 weeks of study Endocrine therapy: - Not specified Radiotherapy: - Prior definitive external-beam radiotherapy (i.e., at least 5,000 cGy) required - No concurrent radiotherapy or brachytherapy during first 4 weeks of study Surgery: - Prior cytoreductive surgery for supratentorial brain tumor required - Biopsy alone not sufficient Other: - No concurrent investigational therapy during first 8 weeks of study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AlessandroOlivi, Study Chair, Sidney Kimmel Cancer Center
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3295
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
Additional Information:
Study ID Numbers: CDR0000065129; NABTT-101-9601,JHOC-NABTT-101-9601,NCI-T96-0052H
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004028
Other Adult Anaplastic Oligodendroglioma Studies:
1. Carmustine Wafers Plus Irinotecan in Treating Patients With Recurrent Supratentorial High Grade Gliomas
2. Carmustine Followed By Surgery in Treating Patients With Recurrent Supratentorial Malignant Glioma or Metastatic Brain Neoplasm
3. BMS 247550 in Treating Patients With Recurrent Glioma
4. Thalidomide, Celecoxib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Malignant Glioma
5. Carboplatin Plus Irinotecan in Treating Patients With Glioblastoma Multiforme
Related Studies:
Other adult anaplastic oligodendroglioma Clinical Trials
Other Texas Clinical Trials
Other San Antonio Clinical Trials
Carmustine in Treating Patients With Recurrent Malignant Glioma
|
|
|
|
|
|
|
|
