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Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme Clinical research trials and Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme health trials occur in hundreds of cities throughout 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 typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme. Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme clinical trial. Participants oftentimes recieve the most expert healthcare available for their Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme  Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
For Condition: adult glioblastoma multiforme,recurrent adult brain tumor
Status: Suspended
Sponsor(s): Direct Therapeutics ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of carmustine in treating patients who have progressive or recurrent glioblastoma multiforme.
Details: OBJECTIVES: - Determine the maximum tolerated dose of intratumoral carmustine in ethanol (DTI-015) in patients with unresectable recurrent glioblastoma multiforme. (Phase I of this study closed to accrual as of 01/15/2002.) - Determine the qualitative and quantitative toxicity of this regimen in these patients. - Assess the activity of this regimen in these patients. - Estimate peripheral blood carmustine levels in these patients treated with this regimen. OUTLINE: This is a dose-escalation, multicenter study. Patients receive carmustine in ethanol (DTI-015) intratumorally over 5 minutes during stereotactic biopsy or open craniotomy. Cohorts of 3-6 patients receive escalating doses of DTI-015 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity. (Phase I of this study closed to accrual as of 01/15/2002.) Additional patients then receive treatment with DTI-015 at the recommended phase II dose. Patients are followed at 4, 8, and 12 weeks and then every 1-3 months until disease progression. PROJECTED ACCRUAL: A total of 12 patients were accrued for phase I of this study and approximately 14-18 patients will be accrued for phase II of this study. (Phase I of this study closed to accrual as of 01/15/2002.)
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven supratentorial malignant glioblastoma multiforme - Clear evidence of disease progression by MRI - Unresectable tumor that has spherical, spheroid, or ovoid shape (not multicentric or multilobulated) - Central necrosis and/or central cystic areas allowed in the presence of enhancing rim thickness greater than 5 mm - No brainstem (pons or medulla) or midbrain (mesencephalon) involvement - No involvement of primary sensorimotor cortex in the dominant hemisphere or within 1.5 cm of the optic chiasm, either optic nerve, or any other cranial nerve - No tumor extension into the ventricular system - Tumor volume no greater than 33.4 cm3 - At least one prior radiotherapy PATIENT CHARACTERISTICS: Age: - 18 to 75 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 - No evidence of bleeding diathesis Hepatic: - Bilirubin no greater than 2.0 mg/dL - SGOT/SGPT no greater than 2.5 times normal Renal: - Creatinine no greater than 2.0 mg/dL OR - Creatinine clearance at least 40 mL/min - BUN no greater than 30 mg/dL Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No active uncontrolled infection - Afebrile unless fever due to presence of tumor - No other concurrent serious medical or psychiatric illness that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin including Gliadel wafer therapy) and recovered Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy and recovered - No prior intracranial brachytherapy Surgery: - Recovered from any prior surgery Other: - No prior anticoagulants - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GeneResnick, Study Chair, Millennix
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
Massey Cancer Center
Richmond, Virginia, 23298-0631
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
John F. Kennedy Medical Center
Edison, New Jersey, 08820
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Stanford University Medical Center
Stanford, California, 94305-5408
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Barrett Cancer Center
Cincinnati, Ohio, 45219
United States
University of Colorado Cancer Center
Denver, Colorado, 80262
United States
Evanston Northwestern Health Care
Evanston, Illinois, 60201
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9416
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
Additional Information:
Study ID Numbers: CDR0000068207; UCMC-00042402,NCI-V00-1623,DTI-9901
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006656
Other Recurrent Adult Brain Tumor Studies:
1. Computer Planned Radiation Therapy Plus Chemotherapy in Treating Patients With Glioblastoma Multiforme
2. Radiation Therapy Followed by Bleomycin in Treating Adult Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
3. Karenitecin in Treating Patients With Recurrent Malignant Glioma
4. PEG-Interferon alfa-2b With or Without Thalidomide in Treating Patients With Recurrent High-Grade Gliomas
5. Tipifarnib and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Related Studies:
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Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
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