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Boron Neutron Capture Therapy in Treating Patients With Glioblastoma Multiforme or Melanoma Metastatic to the Brain 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 Boron Neutron Capture Therapy in Treating Patients With Glioblastoma Multiforme or Melanoma Metastatic to the Brain conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Boron Neutron Capture Therapy in Treating Patients With Glioblastoma Multiforme or Melanoma Metastatic to the Brain Clinical research trials and Boron Neutron Capture Therapy in Treating Patients With Glioblastoma Multiforme or Melanoma Metastatic to the Brain 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 Boron Neutron Capture Therapy in Treating Patients With Glioblastoma Multiforme or Melanoma Metastatic to the Brain. Boron Neutron Capture Therapy in Treating Patients With Glioblastoma Multiforme or Melanoma Metastatic to the Brain 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 Boron Neutron Capture Therapy in Treating Patients With Glioblastoma Multiforme or Melanoma Metastatic to the Brain clinical trial. Subjects often receive the most expert healthcare possible for their Boron Neutron Capture Therapy in Treating Patients With Glioblastoma Multiforme or Melanoma Metastatic to the Brain 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 > "B" Clinical Trials Conditions > Boron Neutron Capture Therapy in Treating Patients With Glioblastoma Multiforme or Melanoma Metastatic to the Brain  Boron Neutron Capture Therapy in Treating Patients With Glioblastoma Multiforme or Melanoma Metastatic to the Brain
Boron Neutron Capture Therapy in Treating Patients With Glioblastoma Multiforme or Melanoma Metastatic to the Brain
For Condition: adult glioblastoma multiforme,brain metastases,Stage 4 Melanoma
Status: Recruiting
Sponsor(s): Beth Israel Deaconess Medical Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Radiation therapy such as boron neutron capture therapy may kill tumor cells without harming normal tissue. PURPOSE: Phase I/II trial to study the effectiveness of boron neutron capture therapy in treating patients who have glioblastoma multiforme or melanomametastatic to the brain.
Details: OBJECTIVES: - Determine the time course, uniformity, and severity of acute and chronic normal tissue reactions in patients with glioblastoma multiforme or intracranial melanoma treated with boronophenylalanine-fructose complex (BPA-f) followed by cranial neutron irradiation using a new fission converter beam facility. - Determine the maximum tolerated dose of cranial neutron capture therapy in these patients. - Determine, through serial objective measurements, the clinical response in patients treated with this therapy. - Determine the pharmacokinetics of BPA-f in these patients. OUTLINE: This is a dose-escalation study of cranial neutron capture therapy (NCT). Patients receive boronophenylalanine-fructose complex IV over 90 minutes followed by cranial NCT on days 1 and 2. Cohorts of 3-6 patients receive escalating doses of NCT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the MTD. Patients are followed at 1, 2, 4, 6, 9, and 12 months and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 16 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed glioblastoma multiforme OR - Radiographically diagnosed brain metastases after a diagnosis of melanoma - Contrast-enhanced tumor volume must not exceed 60 mL PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 6 months Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Creatinine normal Cardiovascular: - No prior severe cardiac disease, including the following: - Uncontrolled arrhythmias or conduction defects - Unstable or newly diagnosed angina pectoris - Recent coronary artery disease - Congestive heart failure Other: - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 6 months after study - No prior phenylketonuria - No cognitive impairment that would preclude informed consent PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No concurrent chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior cranial irradiation Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PaulBusse, Study Chair, Beth Israel Deaconess Medical Center
Massachusetts Institute of Technology *Recruiting*
Cambridge, Massachusetts, 02139
United States
Recruiting Jody Kaplan 617-253-4201
Beth Israel Deaconess Medical Center *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Jody Kaplan 617-667-2345
Additional Information:
Study ID Numbers: CDR0000069398; NEDH-E-010284FB,BIDMC-E-010284FB,NCI-V02-1702
Study Start Date:
Record last reviewed: June 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039572
Other Adult Glioblastoma Multiforme Studies:
1. Surgery in Treating Patients With Metastatic Melanoma
2. Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma
3. Vaccine Therapy in Treating Patients With Stage IV Melanoma
4. Vaccine Therapy in Treating Patients With Stage IV Cutaneous Melanoma
5. Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer
Related Studies:
Other adult glioblastoma multiforme Clinical Trials
Other Massachusetts Clinical Trials
Other Cambridge Clinical Trials
Boron Neutron Capture Therapy in Treating Patients With Glioblastoma Multiforme or Melanoma Metastatic to the Brain
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