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Carmustine Wafers Plus Irinotecan in Treating Patients With Recurrent Supratentorial High Grade Gliomas Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Carmustine Wafers Plus Irinotecan in Treating Patients With Recurrent Supratentorial High Grade Gliomas conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Carmustine Wafers Plus Irinotecan in Treating Patients With Recurrent Supratentorial High Grade Gliomas Clinical research trials and Carmustine Wafers Plus Irinotecan in Treating Patients With Recurrent Supratentorial High Grade Gliomas health trials take place in a lot of of cities across the US. 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 / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Carmustine Wafers Plus Irinotecan in Treating Patients With Recurrent Supratentorial High Grade Gliomas. Carmustine Wafers Plus Irinotecan in Treating Patients With Recurrent Supratentorial High Grade Gliomas Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Carmustine Wafers Plus Irinotecan in Treating Patients With Recurrent Supratentorial High Grade Gliomas clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Carmustine Wafers Plus Irinotecan in Treating Patients With Recurrent Supratentorial High Grade Gliomas condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), 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 > Carmustine Wafers Plus Irinotecan in Treating Patients With Recurrent Supratentorial High Grade Gliomas  Carmustine Wafers Plus Irinotecan in Treating Patients With Recurrent Supratentorial High Grade Gliomas
Carmustine Wafers Plus Irinotecan in Treating Patients With Recurrent Supratentorial High Grade Gliomas
For Condition: adult glioblastoma multiforme,Mixed Gliomas,adult anaplastic astrocytoma,adult brain stem glioma,recurrent adult brain tumor
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Duke Comprehensive Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of carmustine wafers plus irinotecan in treating patients with recurrent supratentorial high grade gliomas.
Details: OBJECTIVES: I. Define the maximum tolerated dose of irinotecan given in combination with Gliadel wafers (carmustine) in patients with recurrent glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma. II. Define the toxicity of irinotecan given in combination with Gliadel wafers in these patients. PROTOCOL OUTLINE: This is a dose escalation study. All patients undergo surgical resection. At the time of surgery, up to eight Gliadel wafers (containing carmustine) are implanted in the resected tumor cavity. Cohorts of 3 patients each receive escalating doses of irinotecan IV over 90 minutes once weekly within 3 weeks after Gliadel wafer implantation. One course of treatment consists of 4 weeks of irinotecan and 2 weeks of rest. If 1 patient experiences dose limiting toxicity (DLT) at a dose level, an additional 3 patients are entered at that same dose level. If 2 patients experience DLT, the maximum tolerated dose (MTD) has been surpassed and a total of 6 patients are treated at the previous dose level. The MTD is defined as the highest dose in which no more than 1 of 6 patients experiences DLT. Treatment continues for up to 12 courses in the absence of unacceptable toxicity and disease progression. Patients are followed for at least 4 months. PROJECTED ACCRUAL: Approximately 18 patients will be accrued into this study over 9 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed recurrent supratentorial glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma - Must be able to undergo surgical resection - At least 1 bidimensionally measurable lesion documented on Gd-MRI within 72 hours after surgical implantation of Gliadel wafers - Not requiring immediate radiotherapy --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior irinotecan; At least 6 weeks since chemotherapy unless there is unequivocal evidence of tumor progression after chemotherapy - Endocrine therapy: At least 1 week of nonincreasing dose of steroids prior to study - Radiotherapy: At least 6 weeks since radiotherapy unless there is unequivocal evidence of tumor progression after radiotherapy; No concurrent radiotherapy - Surgery: Not specified --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 70-100% - Life expectancy: Greater than 12 weeks - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 125,000/mm3; Hematocrit at least 29% - Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN); SGOT or SGPT less than 2.5 times ULN; Alkaline phosphatase less than 2 times ULN - Renal: BUN less than 1.5 times ULN; Creatinine less than 1.5 times ULN - Neurological: Must be neurologically stable - Other: HIV negative No AIDS related illness; No nonmalignant systemic disease that would make patient a poor medical risk; No acute infection requiring intravenous antibiotics; Not pregnant or nursing; Negative pregnancy test 24 hours prior to study; Effective contraception required of all fertile patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HenryFriedman, Study Chair, Duke Comprehensive Cancer Center
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Additional Information:
Study ID Numbers: CDR0000066497; DUMC-0901-01-5R3,NCI-G98-1464,DUMC-000901-00-5R2,DUMC-000901-01-5R3,DUMC-0797-99-5RI,DUMC-796-98-5,DUMC-98065,UCLA-9812060
Study Start Date: July 1998
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003463
Other Mixed Gliomas Studies:
1. Antineoplaston Therapy in Treating Patients With Glioblastoma Multiforme
2. Karenitecin in Treating Patients With Recurrent Malignant Glioma
3. Irinotecan in Treating Patients With Recurrent Malignant Glioma
4. BMS 247550 in Treating Patients With Recurrent Glioma
5. Radiation Therapy Followed by Carmustine in Treating Patients Who Have Supratentorial Glioblastoma Multiforme
Related Studies:
Other Mixed Gliomas Clinical Trials
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Carmustine Wafers Plus Irinotecan in Treating Patients With Recurrent Supratentorial High Grade Gliomas
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