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CC-8490 in Treating Patients With Recurrent or Refractory High-Grade Gliomas 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 CC-8490 in Treating Patients With Recurrent or Refractory High-Grade Gliomas conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. CC-8490 in Treating Patients With Recurrent or Refractory High-Grade Gliomas Clinical research trials and CC-8490 in Treating Patients With Recurrent or Refractory High-Grade Gliomas 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 CC-8490 in Treating Patients With Recurrent or Refractory High-Grade Gliomas. CC-8490 in Treating Patients With Recurrent or Refractory High-Grade Gliomas 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 CC-8490 in Treating Patients With Recurrent or Refractory High-Grade Gliomas clinical trial. Subjects often receive the most expert healthcare possible for their CC-8490 in Treating Patients With Recurrent or Refractory High-Grade Gliomas 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 > "C" Clinical Trials Conditions > CC-8490 in Treating Patients With Recurrent or Refractory High-Grade Gliomas  CC-8490 in Treating Patients With Recurrent or Refractory High-Grade Gliomas
CC-8490 in Treating Patients With Recurrent or Refractory High-Grade Gliomas
For Condition: recurrent adult brain tumor,adult glioblastoma multiforme,adult brain stem glioma,adult anaplastic astrocytoma,adult anaplastic oligodendroglioma,Mixed Gliomas
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Drugs used in chemotherapy, such as CC-8490, use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of CC-8490 in treating patients who have recurrent or refractory high-gradegliomas.
Details: OBJECTIVES: Primary - Determine the maximum tolerated dose of CC-8490 in patients with recurrent or refractory high-grade gliomas. - Determine, preliminarily, the toxic effects of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. Secondary - Determine, preliminarily, the potential anti-glioma activity of this drug in these patients. OUTLINE: This is a dose-escalation study. Patients receive oral CC-8490 once daily on days 1 and 3-28 (course 1 only). Beginning with course 2 and for all subsequent courses, patients receive oral CC-8490 once daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of CC-8490 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, a total of 10 patients are treated at that dose. Patients are followed within 2 weeks. PROJECTED ACCRUAL: A total of 3-34 patients will be accrued for this study within 12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed supratentorial malignant glioma, including any of the following: - Glioblastoma multiforme - Gliosarcoma - Anaplastic astrocytoma - Anaplastic oligodendroglioma - Anaplastic mixed oligoastrocytoma - Malignant glioma/astrocytoma not otherwise specified - Radiographically diagnosed infiltrating brain stem gliomas not amenable to biopsy allowed - Recurrent or progressive disease as determined by 1 of the following: - CT scan or MRI within the past 21 days - Biopsy within the past 12 weeks - Failed prior radiotherapy PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 60-100% Life expectancy - More than 8 weeks Hematopoietic - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 (transfusion independent) - Hemoglobin at least 8 g/dL (transfusion allowed) Hepatic - Bilirubin no greater than 1.5 mg/dL - AST and ALT no greater than 2 times upper limit of normal - No significant active hepatic disease that would preclude study participation Renal - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min - No significant active renal disease that would preclude study participation Cardiovascular - No significant active cardiac disease that would preclude study participation Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 2 months after study participation - No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No significant active psychiatric disease that would preclude study participation - No other condition or laboratory abnormality that would preclude study participation - Able to swallow capsules whole PRIOR CONCURRENT THERAPY: Biologic therapy - At least 2 weeks since prior interferon - No concurrent immunotherapy Chemotherapy - At least 2 weeks since prior vincristine - At least 3 weeks since prior procarbazine - At least 4 weeks since prior temozolomide or carboplatin - At least 6 weeks since prior nitrosoureas - No other concurrent anticancer chemotherapy Endocrine therapy - At least 2 weeks since prior tamoxifen - Concurrent steroids allowed provided dose has been stable for at least 5 days prior to study enrollment Radiotherapy - See Disease Characteristics - At least 2 weeks since prior radiotherapy - No concurrent radiotherapy Surgery - At least 2 weeks since prior resection of a recurrent or progressive tumor Other - At least 2 weeks since other prior non-cytotoxic therapy - At least 4 weeks since other prior cytotoxic therapies - More than 28 days since prior experimental study drugs - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HowardFine, Principal Investigator, Neuro-Oncology Branch
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Additional Information:
Study ID Numbers: CDR0000343702; NCI-04-C-0017
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00074243
Other Adult Brain Stem Glioma Studies:
1. Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme
2. Talampanel and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
3. Suramin in Treating Patients With Recurrent Primary Brain Tumors
4. Tipifarnib and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
5. COL-3 in Treating Patients With Progressive or Recurrent Brain Tumors
Related Studies:
Other adult brain stem glioma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
CC-8490 in Treating Patients With Recurrent or Refractory High-Grade Gliomas
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