|
BMS 247550 in Treating Patients With Recurrent Glioma 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 BMS 247550 in Treating Patients With Recurrent Glioma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. BMS 247550 in Treating Patients With Recurrent Glioma Clinical research trials and BMS 247550 in Treating Patients With Recurrent Glioma 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 BMS 247550 in Treating Patients With Recurrent Glioma. BMS 247550 in Treating Patients With Recurrent Glioma 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 BMS 247550 in Treating Patients With Recurrent Glioma clinical trial. Subjects often receive the most expert healthcare possible for their BMS 247550 in Treating Patients With Recurrent Glioma 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.
|
|
|
|
|
|
|
Home > "B" Clinical Trials Conditions > BMS 247550 in Treating Patients With Recurrent Glioma  BMS 247550 in Treating Patients With Recurrent Glioma
BMS 247550 in Treating Patients With Recurrent Glioma
For Condition: recurrent adult brain tumor,adult glioblastoma multiforme,adult anaplastic oligodendroglioma,Mixed Gliomas,adult anaplastic astrocytoma
Status: Recruiting
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/II trial to study the effectiveness of BMS-247550 in treating patients who have recurrentglioma.
Details: OBJECTIVES: - Determine the maximum tolerated dose of BMS-247550 in patients with recurrent high-grade glioma who are receiving or not receiving cytochrome P450-inducing anticonvulsants. - Determine the pharmacokinetics of this drug in these patients. - Determine the response rate of patients treated with this drug. - Determine the toxicity of this drug in these patients. - Determine the 6-month progression-free survival, duration of progression-free survival, and overall survival of patients treated with this drug. OUTLINE: This is a phase I, dose-escalation, multicenter study followed by a phase II, safety and efficacy, multicenter study. For phase I only, patients are stratified according to cytochrome P450-inducing anticonvulsant use (yes vs no). - Patients receive BMS-247550 IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3 patients receive escalating doses of BMS-247550 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity. - Phase II: Once the MTD is determined, additional patients receive BMS-247550 as above at the MTD. Patients are followed every 2 months. PROJECTED ACCRUAL: A minimum of 10-15 patients will be accrued for the phase I portion of this study. A total of 22-33 patients will be accrued for the phase II portion of this study within 4-6 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed malignant glioma - Anaplastic astrocytoma, glioblastoma multiforme, anaplastic oligodendroglioma, or anaplastic mixed glioma - Recurrent or progressive after radiotherapy with or without chemotherapy - Prior low-grade glioma that has progressed to high-grade glioma allowed - Measurable disease by MRI or CT scan 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 - Hemoglobin greater than 9 g/dL Hepatic - Bilirubin no greater than 1.5 mg/dL - AST/ALT no greater than 2.5 times upper limit of normal Renal - Creatinine no greater than 1.5 mg/dL Other - Mini mental score at least 15 - No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast - No concurrent serious infection or medical illness that would preclude study therapy - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - No more than 2 prior chemotherapy regimens - At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - At least 3 months since prior radiotherapy Surgery - Not specified Other - Recovered from prior therapy - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidPeereboom, Study Chair, Cleveland Clinic Foundation Hospital
Josephine Ford Cancer Center at Henry Ford Hospital *Recruiting*
Detroit, Michigan, 48202
United States
Recruiting Mark Rosenblum 313-916-1340
Winship Cancer Institute of Emory University *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting David Lawson 404-778-4189
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Stuart Grossman 410-955-8837
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting David Peereboom 216-445-6068
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting Steven Brem 813-979-3063
Massachusetts General Hospital Cancer Center *Recruiting*
Boston, Massachusetts, 02114-2617
United States
Recruiting Alison O'Neill 617-724-8220
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1030
United States
Recruiting Edward Shaw 336-716-4647
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Louis Nabors 205-934-1432
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Jane Alavi 215-662-6319
Additional Information:
Study ID Numbers: CDR0000257118; NABTT-2111,JHOC-NABTT-2111
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045708
Other Adult Anaplastic Oligodendroglioma Studies:
1. Temozolomide, Thalidomide, and Celecoxib Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
2. Fenretinide in Treating Patients With Recurrent Malignant Glioma
3. Radiation Therapy With or Without Chemotherapy in Treating Patients With Anaplastic Oligodendroglioma
4. CCI-779 in Treating Patients With Malignant Glioma
5. Immunotoxin Therapy in Treating Patients With Malignant Glioma
Related Studies:
Other adult anaplastic oligodendroglioma Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
BMS 247550 in Treating Patients With Recurrent Glioma
|
|
|
|
|
|
|
|
