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Imatinib Mesylate in Treating Patients With Gliomas 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 Imatinib Mesylate in Treating Patients With Gliomas conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Imatinib Mesylate in Treating Patients With Gliomas Clinical research trials and Imatinib Mesylate in Treating Patients With Gliomas 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 Imatinib Mesylate in Treating Patients With Gliomas. Imatinib Mesylate in Treating Patients With Gliomas 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 Imatinib Mesylate in Treating Patients With Gliomas clinical trial. Participants frequently get the best healthcare available for their Imatinib Mesylate in Treating Patients With Gliomas 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 > "I" Clinical Trials Conditions > Imatinib Mesylate in Treating Patients With Gliomas  Imatinib Mesylate in Treating Patients With Gliomas
Imatinib Mesylate in Treating Patients With Gliomas
For Condition: Adult Oligodendroglioma,adult brain tumor,adult noninfiltrating astrocytoma,adult infiltrating astrocytoma,Mixed Gliomas
Status: Recruiting
Sponsor(s): EORTC New Drug Development Group , EORTC Brain Tumor Cooperative Group
Synopsis: RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and slow the growth of the tumor. PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have gliomas.
Details: OBJECTIVES: - Determine the therapeutic activity of imatinib mesylate (in terms of objective response and progression-free survival at 6 months) in patients with gliomas. - Determine the safety of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to glioma (glioblastoma multiforme vs anaplastic oligodendroglioma or mixed oligoastrocytoma vs anaplastic astrocytoma or recurrent low-grade astrocytoma). Patients receive oral imatinib mesylate once or twice daily. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 6 months and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 77 patients (29 patients with glioblastoma multiforme, 24 patients with anaplastic oligodendroglioma or mixed oligoastrocytoma, and 24 patients with anaplastic astrocytoma or recurrent low-grade astrocytoma) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed glioblastoma multiforme - Recurrent disease by CT scan or MRI - No prior chemotherapy OR - No more than 1 prior chemotherapy regimen in adjuvant setting or for recurrent disease OR - Histologically or cytologically confirmed anaplastic oligodendroglioma, mixed oligoastrocytoma, anaplastic astrocytoma, or recurrent low-grade astrocytoma - Failed prior radiotherapy - No more than 1 prior chemotherapy regimen - Failed adjuvant chemotherapy OR - Failed first-line chemotherapy - At least 1 bidimensionally measurable target lesion - At least 2 cm on contrast-enhanced CT scan or MRI PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Neutrophil count at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST and ALT no greater than 2.5 times ULN - Alkaline phosphatase no greater than 2.5 times ULN Renal: - Creatinine less than 1.7 mg/dL Cardiovascular: - Cardiac function normal - No ischemic heart disease within the past 6 months - Normal 12-lead ECG Other: - No other prior or concurrent malignancy except cone-biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer - No unstable systemic disease - No active uncontrolled infection - No psychological, familial, sociological, or geographical condition that would preclude study compliance - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent anticancer biologic agents - No concurrent cytokines (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea) - No concurrent chemotherapy Endocrine therapy: - Must be on stable or decreasing dose of corticosteroids for at least 2 weeks Radiotherapy: - See Disease Characteristics - At least 3 months since prior brain irradiation - No prior high-dose radiotherapy (more than 65 Gy), stereotactic radiosurgery, or internal radiotherapy unless the recurrence is histologically confirmed - No concurrent radiotherapy Surgery: - Prior surgery for primary brain tumor within the past 3 months allowed provided one of the following conditions are present: - Postoperative imaging within 72 hours after surgery shows a clearly limited target lesion of at least 2 cm - Postoperative follow-up shows a progressive and measurable target lesion - A second measurable target lesion is present outside the surgical area Other: - No concurrent warfarin or other anticoagulants - No other concurrent anticancer agents - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EricRaymond, , Institut Gustave Roussy
Institut Gustave Roussy *Recruiting*
Villejuif, , F-94805
France
Recruiting Contact Person 33-1-4211-4211
Beatson Oncology Centre *Recruiting*
Glasgow, Scotland, G11 6NT
United Kingdom
Recruiting Contact Person 44-141-330-4006
Centre Antoine Lacassagne *Recruiting*
Nice, , 06189
France
Recruiting Contact Person 33-4-9203-1000
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc *Recruiting*
Dijon, , 21079
France
Recruiting Contact Person 33-3-8073-7500
Daniel Den Hoed Cancer Center at Erasmus Medical Center *Recruiting*
Rotterdam, , 3008 AE
Netherlands
Recruiting Contact Person 31-10-439-1911
Centre Hospitalier Universitaire Vaudois *Recruiting*
Lausanne, , CH-1011
Switzerland
Recruiting Contact Person 41-21-314-1111
CRLCC Nantes - Atlantique *Recruiting*
Nantes-Saint Herblain, , 44805
France
Recruiting Contact Person 33-240-679-900
Kaiser Franz Josef Hospital *Recruiting*
Vienna, , A-1100
Austria
Recruiting Contact Person 43-1-601-9152
Azienda Ospedaliera di Padova *Recruiting*
Padova, , 35100
Italy
Recruiting Contact Person 39-49-821-2970
U.Z. Gasthuisberg *Recruiting*
Leuven, , B-3000
Belgium
Recruiting Contact Person 32-16-332-211
Additional Information:
Study ID Numbers: CDR0000069377; EORTC-16011,EORTC-26013
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039364
Other Adult Infiltrating Astrocytoma Studies:
1. Imatinib Mesylate in Treating Patients With Gliomas
2. Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma
3. Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma
4. Lonafarnib and Temozolomide in Treating Patients With Recurrent Primary Supratentorial Gliomas
5. Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma
Related Studies:
Other adult infiltrating astrocytoma Clinical Trials
Other Clinical Trials
Other Nantes-Saint Herblain Clinical Trials
Imatinib Mesylate in Treating Patients With Gliomas
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