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COL-3 in Treating Patients With Progressive or Recurrent Brain Tumors Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about COL-3 in Treating Patients With Progressive or Recurrent Brain Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. COL-3 in Treating Patients With Progressive or Recurrent Brain Tumors Clinical research trials and COL-3 in Treating Patients With Progressive or Recurrent Brain Tumors medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as COL-3 in Treating Patients With Progressive or Recurrent Brain Tumors. COL-3 in Treating Patients With Progressive or Recurrent Brain Tumors Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a COL-3 in Treating Patients With Progressive or Recurrent Brain Tumors clinical trial. Participants frequently get the best healthcare available for their COL-3 in Treating Patients With Progressive or Recurrent Brain Tumors condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > COL-3 in Treating Patients With Progressive or Recurrent Brain Tumors  COL-3 in Treating Patients With Progressive or Recurrent Brain Tumors
COL-3 in Treating Patients With Progressive or Recurrent Brain Tumors
For Condition: adult glioblastoma multiforme,adult anaplastic oligodendroglioma,recurrent adult brain tumor,adult anaplastic astrocytoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: COL-3 may stop the growth of brain tumors by stopping blood flow to the tumor. PURPOSE: Phase I/II trial to study the effectiveness of COL-3 in treating patients who have progressive or recurrent brain tumors following radiation therapy or chemotherapy.
Details: OBJECTIVES: - Determine the maximum tolerated dose, dose limiting toxicity, and safety profile of oral COL-3 alone or when combined with anticonvulsants known to be metabolized by CYP450 in patients with progressive or recurrent high grade anaplastic astrocytoma, anaplastic oligodendroglioma, or glioblastoma multiforme. - Define the pharmacokinetics and pharmacodynamics of COL-3 on this schedule and determine the effects of hepatic enzyme inducing drugs, such as anticonvulsants, on the pharmacokinetics. - Determine the response rate, disease free survival, and survival in patients treated with this regimen. OUTLINE: This is a dose-escalation, multicenter study of COL-3. Patients are stratified by anticonvulsant (anticonvulsants that cause induction of CYP450 vs anticonvulsants that cause modest or no induction of CYP450 or no anticonvulsant). - Patients receive oral COL-3 daily. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of COL-3 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. - Phase II: Patients receive oral COL-3 daily at the MTD from the phase I portion of this study. Patients are followed every 2 months until death. PROJECTED ACCRUAL: A total of 15-18 patients will be accrued for phase I of the study and a total of 35 patients will be accrued for phase II of the study at a rate of 3 patients per month.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven high grade glioma that is progressive or recurrent following radiotherapy or chemotherapy - Anaplastic astrocytoma - Anaplastic oligodendroglioma - Glioblastoma multiforme - Prior low grade glioma that has progressed to high grade glioma following radiotherapy and/or chemotherapy 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 Hepatic: - Bilirubin normal - SGOT or SGPT no greater than 2.5 times upper limit of normal Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance greater than 60 mL/min Cardiovascular: - No myocardial infarction, stroke, or congestive heart failure within the past 3 months Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 1 month after study - No serious active infection or medical illness that would preclude compliance - HIV negative - No history of gastrointestinal disorders that would interfere with absorption of study drug - No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or breast, or basal cell or squamous cell skin cancer - No hypersensitivity to tetracyclines or its derivatives PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent filgrastim (G-CSF) Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks since prior nitrosoureas) and recovered - No more than 2 prior chemotherapy regimens Endocrine therapy: - Not specified Radiotherapy: - No prior large field radiotherapy (greater than 20% of total bone marrow) - At least 3 months since other prior radiotherapy and recovered Surgery: - No prior major upper gastrointestinal surgery - At least 14 days since other prior major surgery Other: - No other concurrent investigational agents - No prolonged sun exposure
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PamelaNew, Study Chair, University of Texas
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
Additional Information:
Study ID Numbers: CDR0000067379; NABTT-9809,JHOC-NABTT-9809
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004147
Other Adult Anaplastic Oligodendroglioma Studies:
1. Chemotherapy in Treating Patients With Progressive or Recurrent Brain Tumors
2. Antineoplaston Therapy in Treating Patients With Residual or Recurrent Anaplastic Astrocytoma
3. Radiolabeled Monoclonal Antibody in Treating Patients With Glioblastoma Multiforme or Anaplastic Astrocytoma
4. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Astrocytoma
5. Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma
Related Studies:
Other adult anaplastic oligodendroglioma Clinical Trials
Other Georgia Clinical Trials
Other Atlanta Clinical Trials
COL-3 in Treating Patients With Progressive or Recurrent Brain Tumors
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