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Gene Therapy in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Gene Therapy in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Gene Therapy in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme Clinical research trials and Gene Therapy in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Gene Therapy in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme. Gene Therapy in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Gene Therapy in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme clinical trial. Participants oftentimes recieve the finest healthcare available for their Gene Therapy in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "G" Clinical Trials Conditions > Gene Therapy in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme  Gene Therapy in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme
Gene Therapy in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme
For Condition: adult glioblastoma multiforme,recurrent adult brain tumor
Status: Suspended
Sponsor(s): Biogen Idec ,
Synopsis: RATIONALE: Inserting the gene for interferon-beta into a person's glioblastoma cells may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who have recurrent or progressiveglioblastoma multiforme.
Details: OBJECTIVES: - Determine the major toxic effects of intratumor BG00001 (adenoviral vector encoding human interferon beta) in patients with recurrent or progressive glioblastoma multiforme. - Determine the maximum tolerated dose of this drug in these patients. - Determine the 6-month progression-free survival and 12-month overall survival of patients treated with this drug. - Determine the immune response in patients treated with this drug. - Determine the anti-tumor activity of this drug in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive intratumor BG00001 by stereotactic injection on day 1. Patients undergo tumor resection and receive the second injection of BG00001 into the tumor bed and remaining tumor on day 8 in the absence of unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of BG00001 until the maximum tolerated dose (MTD) is determined. The MTD is defined as one dose level below that at which either 2 of 3 or 2 or more of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 14-17 additional patients receive treatment as above with the MTD of BG00001. Patients are followed on days 9, 10, 11, 12, 15, 22, and 29; weeks 8, 17, 26, and 52; and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 3-50 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed glioblastoma multiforme - Recurrent or progressive disease after prior treatment as evidenced by gadolinium-enhanced MRI - Recurrent or progressive tumor must be confirmed as malignant by biopsy - Resection must be clinically indicated - Tumor must be amenable to radical resection - Must be on anticonvulsant therapy with therapeutic serum levels for at least 2 weeks prior to study - No brainstem or optic chiasm involvement of tumor - No more than 1 cm linear dimension of contact between gadolinium-enhancing tumor and a cerebral ventricle PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 Hepatic: - ALT and AST no greater than 4 times upper limit of normal (ULN) - PT no greater than 2 seconds above ULN - Bilirubin no greater than 1.5 mg/dL Renal: - Creatinine no greater than 2 times ULN - Sodium 125-150 mEq/L - Potassium 3.5-5.5 mEq/L Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior intolerance to corticosteroids - No medical condition that would preclude the use of corticosteroids - No uncontrolled seizure disorder - No other clinically significant, uncontrolled medical illness - No other invasive malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer, superficial transitional cell carcinoma of the bladder, or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior BG00001 - No prior treatment with a gene delivery vector or therapeutic adenovirus Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) - No concurrent chemotherapy Endocrine therapy: - Must receive corticosteroids beginning at least 1 week before baseline MRI and ending after the second dose of study drug Radiotherapy: - At least 8 weeks since prior radiotherapy, including interstitial radiation or radiosurgery - No concurrent radiotherapy Surgery: - See Disease Characteristics Other: - See Disease Characteristics - At least 4 weeks since prior investigational drugs or therapy - No other investigational or approved anticancer therapy during and for 8 weeks after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StevenRosenfeld, Study Chair, UAB Comprehensive Cancer Center
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, 85724
United States
Abramson Cancer Center at University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104-4283
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, 80262
United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94115
United States
Additional Information:
Study ID Numbers: CDR0000069312; NCI-V02-1696,BIOGEN-C-1502,UARIZ-HSC-01197
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036725
Other Recurrent Adult Brain Tumor Studies:
1. SarCNU in Treating Patients With Recurrent Malignant Glioma
2. Taurolidine in Treating Patients With Recurrent or Progressive Glioma
3. Topotecan and Thalidomide in Treating Patients With Recurrent or Refractory Malignant Glioma
4. Phosphorus 32 in Treating Patients With Glioblastoma Multiforme
5. Gefitinib Plus Temozolomide in Treating Patients With Malignant Primary Glioma
Related Studies:
Other recurrent adult brain tumor Clinical Trials
Other Arizona Clinical Trials
Other Tucson Clinical Trials
Gene Therapy in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme
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