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Irinotecan in Treating Patients With Recurrent Malignant Glioma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Irinotecan in Treating Patients With Recurrent Malignant Glioma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Irinotecan in Treating Patients With Recurrent Malignant Glioma Clinical research trials and Irinotecan in Treating Patients With Recurrent Malignant Glioma healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Irinotecan in Treating Patients With Recurrent Malignant Glioma. Irinotecan in Treating Patients With Recurrent Malignant Glioma Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Irinotecan in Treating Patients With Recurrent Malignant Glioma clinical trial. Human subjects often receive the most effective healthcare possible for their Irinotecan in Treating Patients With Recurrent Malignant Glioma condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Irinotecan in Treating Patients With Recurrent Malignant Glioma  Irinotecan in Treating Patients With Recurrent Malignant Glioma
Irinotecan in Treating Patients With Recurrent Malignant Glioma
For Condition: recurrent adult brain tumor,adult anaplastic astrocytoma,adult glioblastoma multiforme
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Johns Hopkins Oncology Center
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 irinotecan in treating patients with recurrent malignant glioma.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of intravenous irinotecan when administered weekly for 4 weeks in patients with recurrent malignant gliomas. II. Describe the pharmacokinetics of this route of administration, measuring both irinotecan and the active metabolite SN-38, and determine the effects of hepatic enzyme inducing drugs, such as anticonvulsants, on the pharmacokinetics in these patients. III. Determine preliminary response data and activity of irinotecan in this patient population. IV. Correlate response with topoisomerase I levels in brain tumor tissue from patients undergoing treatment. PROTOCOL OUTLINE: Patients are stratified based on their use/kind of anticonvulsant drugs. This stratification yields two arms for this study. Arm I consists of patients who use anticonvulsant drugs that induce hepatic metabolic enzymes. Arm II consists of patients who use anticonvulsant drugs that cause modest to no induction of hepatic metabolic enzymes or no anticonvulsant drug. Three patients in each arm receive irinotecan by 90-minute IV infusions every week for 4 weeks, followed by a 2 week rest period. The dose is escalated for the next cohort of 3 patients in the absence of unacceptable dose limiting toxicity. The 6 week course is repeated until unacceptable toxicity or disease progression. Once the maximum tolerated dose has been established for each arm, additional patients are treated at that dose level. Patients are followed every 2 months. PROJECTED ACCRUAL: A minimum of 3 patients will be accrued into the phase I portion of the study and a total of 18-35 patients will be accrued into each arm of the phase II portion of the study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed malignant glioma that is progressive or recurrent following radiation therapy or chemotherapy; Anaplastic astrocytoma; Glioblastoma multiforme - Low grade glioma that has progressed to biopsy proven high grade glioma is eligible if the progression occurred after radiotherapy with or without chemotherapy - Measurable progression or recurrence by serial MR or CT imaging --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior topoisomerase 1 inhibitor (topotecan, irinotecan, 9- aminocamptothecin); No more that 1 prior chemotherapy regimen; At least 6 weeks since nitrosourea and recovered; At least 3 weeks since any other chemotherapy and recovered - Endocrine therapy: Not specified - Radiotherapy: At least 3 months since completion of most recent course of radiotherapy and recovered - Surgery: Not specified - Other: No concurrent investigational agents; At least 14 days since prior valproic acid; No concurrent valproic acid --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60-100% - Life expectancy: Greater than 2 months - Hematopoietic: Absolute neutrophil count 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; Transaminases no greater than 4 times upper limit of normal - Renal: Creatinine no greater than 1.7 mg/dL - Cardiovascular: No uncontrolled hypertension; No angina pectoris; No evidence of uncontrolled cardiac dysrhythmia - Other: No serious infection or other medical illness; No other prior or concurrent malignancy within 5 years except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast; Not pregnant or nursing; Adequate contraception required of all fertile patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TracyBatchelor, Study Chair, Johns Hopkins Oncology Center
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston Salem, North Carolina, 27157-1082
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
United States
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
Additional Information:
Study ID Numbers: CDR0000066241; JHOC-NABTT-9711
Study Start Date: July 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003301
Other Recurrent Adult Brain Tumor Studies:
1. BMS 247550 in Treating Patients With Recurrent Glioma
2. Carmustine in Treating Patients With Recurrent Malignant Glioma
3. Temozolomide Plus Irinotecan in Treating Patients With Recurrent Malignant Glioma
4. Surgery, Radiation Therapy, and Chemotherapy With or Without Photodynamic Therapy in Treating Patients With Newly Diagnosed or Recurrent Malignant Supratentorial Gliomas
5. Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma
Related Studies:
Other recurrent adult brain tumor Clinical Trials
Other Florida Clinical Trials
Other Tampa Clinical Trials
Irinotecan in Treating Patients With Recurrent Malignant Glioma
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