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Irinotecan in Treating Patients With Progressive or Recurrent Malignant Glioma Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Irinotecan in Treating Patients With Progressive or Recurrent Malignant Glioma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Irinotecan in Treating Patients With Progressive or Recurrent Malignant Glioma Clinical research trials and Irinotecan in Treating Patients With Progressive or Recurrent Malignant Glioma healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Irinotecan in Treating Patients With Progressive or Recurrent Malignant Glioma. Irinotecan in Treating Patients With Progressive or Recurrent Malignant Glioma Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Irinotecan in Treating Patients With Progressive or Recurrent Malignant Glioma clinical trial. Participants typically obtain the most effective healthcare available for their Irinotecan in Treating Patients With Progressive or Recurrent Malignant Glioma condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Irinotecan in Treating Patients With Progressive or Recurrent Malignant Glioma  Irinotecan in Treating Patients With Progressive or Recurrent Malignant Glioma
Irinotecan in Treating Patients With Progressive or Recurrent Malignant Glioma
For Condition: adult infiltrating astrocytoma,recurrent adult brain tumor,adult brain stem glioma,Mixed Gliomas,Adult Oligodendroglioma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , North American Brain Tumor Consortium
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 who have progressive or recurrent malignant glioma.
Details: OBJECTIVES: I. Determine the maximum tolerated dose and the dose limiting toxicities of irinotecan in patients with progressive or recurrent malignant glioma. II. Define the safety profile of every 3 week dosing of irinotecan in these patients. III. Characterize the pharmacokinetic profile of this regimen in these patients. IV. Assess evidence of antitumor activity in these patients. V. Determine the efficacy of irinotecan in these patients as measured by 6 month progression-free survival and objective tumor response. VI. Evaluate further the safety profile of irinotecan in these patients during phase II study. PROTOCOL OUTLINE: This is a dose escalation study. Patients are stratified according to concurrent enzyme-inducing antiepileptic drugs (EIAEDs)(yes vs no). Group A (without EIAEDs): Patients receive irinotecan IV over 90 minutes on day 1, followed by up to 3 weeks of rest. Group B (with EIAEDs): Patients receive the same treatment but dose escalation is performed in cohorts of 3 patients. The maximum tolerated dose (MTD) is defined as the dose below that at which 2 of 6 patients experience dose limiting toxicities. The Phase I MTD is the starting dose recommended for use in the Phase II portion of the study. Treatment continues every 3 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 3 months for 1 year, every 4 months for 1 year, then every 6 months until disease progression. Patients are then followed every 4 months for survival. PROJECTED ACCRUAL: Up to 30 patients will be accrued for phase I within 10 months. A total of 48 patients will be accrued for phase II within 6-8 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven progressive or recurrent primary malignant glioma - Phase I (excluding group A patients): No more than 2 prior chemotherapy regimens, including 1 prior adjuvant therapy and 1 prior regimen for recurrent or progressive tumor, or 2 prior regimens for progressive tumor - Phase II and/or group A patients: No more than 1 prior chemotherapy regimen, either as adjuvant or for recurrent disease - Measurable disease by MRI or CT scan --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent immunotherapy; No concurrent sargramostim (GM-CSF) Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or suramin); No prior irinotecan, topotecan, or other topotecan 1 inhibitors; No other concurrent chemotherapy - Endocrine therapy: Stable or decreasing dosage of corticosteroids within 72 hours of study entry (phase II only); No other concurrent immunosuppressive agents; No concurrent hormonal therapy - Radiotherapy: At least 4 weeks since prior radiotherapy; Patients with prior interstitial brachytherapy or stereotactic radiosurgery must have confirmation of progressive disease; No concurrent radiotherapy - Surgery: At least 3 weeks since prior resection - Other: Acute toxic effects (excluding neurotoxicity or alopecia) of any prior therapy must be resolved; No concurrent valproic acid as a single agent; Concurrent enzyme-inducing antiepileptic drugs (EIAED) with or without steroids are allowed; No concurrent investigational drugs --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60-100% - Life expectancy: Not specified - Hematopoietic: Neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; SGOT no greater than 3 times upper limit of normal - Renal: Creatinine no greater than 1.5 mg/dL - Cardiovascular: No uncontrolled hypertension; No unstable angina; No symptomatic congestive heart failure; No myocardial infarction within 6 months; No serious uncontrolled cardiac arrhythmia - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No severe nonmalignant systemic disease or active infection; No concurrent alcoholism or drug abuse; No psychosis; HIV negative
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelPrados, Study Chair, North American Brain Tumor Consortium
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Additional Information:
Study ID Numbers: CDR0000066694; NABTC-9801
Study Start Date: September 1998
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003616
Other Adult Oligodendroglioma Studies:
1. Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma
2. Lonafarnib and Temozolomide in Treating Patients With Recurrent Primary Supratentorial Gliomas
3. Pyrazoloacridine Plus Carboplatin in Treating Patients With Recurrent Glioma
4. Imatinib Mesylate in Treating Patients With Gliomas
5. Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma
Related Studies:
Other Adult Oligodendroglioma Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Irinotecan in Treating Patients With Progressive or Recurrent Malignant Glioma
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