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Surgery Followed by Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Surgery Followed by Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Surgery Followed by Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme Clinical research trials and Surgery Followed by Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Surgery Followed by Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme. Surgery Followed by Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Surgery Followed by Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme clinical trial. Subjects frequently get the best healthcare possible for their Surgery Followed by Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Surgery Followed by Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme  Surgery Followed by Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Surgery Followed by Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
For Condition: adult glioblastoma multiforme
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. External-beam radiation therapy uses high-energy x-rays to kill tumor cells. Combining internal radiation with external-beam radiation therapy may kill any remaining tumor cells following surgery. PURPOSE: Phase I trial to study the effectiveness of combining internal radiation therapy with external-beam radiation therapy in treating patients who have undergone surgery for glioblastoma multiforme.
Details: OBJECTIVES: - Determine the maximum tolerated dose of brachytherapy administered via GliaSite RTSâ„¢ applicator followed by external beam radiotherapy in patients with newly diagnosed glioblastoma multiforme. - Determine the acute and chronic toxicity of brachytherapy administered via GliaSite RTSâ„¢ in these patients. - Determine the survival rate of patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of brachytherapy. Patients undergo craniotomy for histologic confirmation of glioblastoma multiforme, surgical resection, and placement of a GliaSite RTSâ„¢ applicator that includes Iotrexâ„¢. Beginning 3-21 days after surgery, patients undergo brachytherapy via the GliaSite RTSâ„¢ applicator. Within 30 days of brachytherapy (no more than 60 days after resection) patients undergo external beam radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 5-10 patients receive escalating doses of brachytherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 5 or 3 of 10 patients experience dose-limiting toxicity. Patients are followed at 21-35 days, every 2 months for 1 year, and then for survival. PROJECTED ACCRUAL: A total of 15-100 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: - Clinically suspected supratentorial grade IV glioblastoma multiforme - Candidate for maximal surgical resection of tumor mass - Expected residual enhancing tumor must be within the expected brachytherapy treatment volume - Resection must not be expected to result in a new permanent neurologic deficit - No clearly multi-focal disease (2 or more separate foci of contrast-enhancing tumor not all within the expected brachytherapy prescription volume by MRI) - No enhancing tumor greater than 1 cm beyond the midline by MRI - No grossly or radiographically apparent leptomeningeal spread and/or ventricular invasion outside the anticipated radiation treatment volume - No marked edema by MRI with significant shift that is not anticipated to be corrected by resection PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 60-100% Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Not specified Renal - Creatinine no greater than 1.7 mg/dL - BUN no greater than 2 times upper limit of normal Cardiovascular - No uncontrolled hypertension - No unstable angina pectoris - No uncontrolled cardiac dysrhythmia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Mini mental state exam score at least 15 - No other concurrent medical illness that would preclude study participation - No concurrent serious infection - No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy - No immunotherapy prior to, during, or within 90 days after brachytherapy - No biologic therapy with any of the following prior to, during, or within 90 days after brachytherapy : - Immunotoxins - Immunoconjugates - Antiangiogenesis compounds - Peptide receptor antagonists - Interferons - Interleukins - Tumor-infiltrating lymphocytes - Lymphokine-activated killer cells - Gene therapy - Antisense agents Chemotherapy - No chemotherapy or polifeprosan 20 with carmustine implant (Gliadel wafers) prior to, during, or within 90 days after brachytherapy Endocrine therapy - No hormonal therapy prior to, during, or within 90 days after brachytherapy - Concurrent corticosteroids to improve quality of life allowed Radiotherapy - No other radiotherapy prior to, during, or within 90 days after brachytherapy Surgery - See Disease Characteristics - No radiosurgery prior to, during, or within 90 days after brachytherapy Other - No other investigational agents directed at the brain tumor prior to, during, or within 90 days after brachytherapy - Concurrent noncytotoxic therapy to improve quality of life allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
VolkerStieber, Study Chair, Comprehensive Cancer Center of Wake Forest University
Massachusetts General Hospital Cancer Center *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting E. Chiocca 617-726-3779
Josephine Ford Cancer Center at Henry Ford Hospital *Recruiting*
Detroit, Michigan, 48202
United States
Recruiting Tom Mikkelsen 313-916-8641
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting Steven Brem 813-979-3063
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3295
United States
Recruiting James Markert 205-975-6985
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Jane Alavi 215-662-6319
University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio, Texas, 78284-7811
United States
Recruiting Pamela New 210-617-5161
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1082
United States
Recruiting Glenn Lesser 336-716-9527
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Gene Barnett 216-444-1379
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Stuart Grossman 410-955-8837
Winship Cancer Institute of Emory University *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting Ian Crocker 404-778-3473
Additional Information:
Study ID Numbers: CDR0000269300; NABTT-2105,JHOC-NABTT-2105
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053183
Other Adult Glioblastoma Multiforme Studies:
1. Irinotecan Plus Radiation Therapy Followed By Chemotherapy in Treating Patients With Glioblastoma Multiforme
2. Combination Chemotherapy for Patients With Brain Cancer
3. Tipifarnib and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
4. Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme
5. Temozolomide and O6-benzylguanine in Treating Patients With Newly Diagnosed, Recurrent, or Progressive Anaplastic Glioma
Related Studies:
Other adult glioblastoma multiforme Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Surgery Followed by Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
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