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Home > "I" Clinical Trials Conditions > Imatinib Mesylate in Treating Patients With Recurrent Brain Tumor  Imatinib Mesylate in Treating Patients With Recurrent Brain Tumor
Imatinib Mesylate in Treating Patients With Recurrent Brain Tumor
For Condition: recurrent adult brain tumor,Mixed Gliomas,adult well-differentiated oligodendroglioma,adult anaplastic oligodendroglioma
Status: Recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent brain tumor that has not responded to previous surgery and radiation therapy.
Details: OBJECTIVES: - Determine the efficacy of imatinib mesylate, as measured by response, survival, and progression-free survival, in patients with recurrent oligodendroglioma or mixed oligoastrocytoma. - Determine the toxicity and safety of this drug in these patients. - Correlate, preliminarily, 1p/19q alterations, alpha-PDFGR gene amplification, and levels of related downstream signaling elements in tumor tissue with clinical response in patients treated with this drug. OUTLINE: This is a multicenter study. Patients are stratified according to concurrent enzyme-inducing anticonvulsant therapy (yes vs no). Patients receive oral imatinib mesylate once or twice daily for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 38 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed oligodendroglioma or mixed oligoastrocytoma - Grade 2-4 - Recurrent disease - Must have received at least 1 but no more than 2 prior chemotherapy regimens - Failed prior surgery and radiotherapy - Progressive disease by MRI or CT scan - Measurable or evaluable disease by MRI or CT scan PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL Hepatic - Bilirubin no greater than 1.5 mg/dL - AST no greater than 3 times upper limit of normal Renal - Creatinine no greater than 2.0 mg/dL Cardiovascular - No myocardial infarction within the past 6 months - No congestive heart failure requiring maintenance therapy for life-threatening ventricular arrhythmias - No New York Heart Association class III or IV heart disease Other - No active uncontrolled infection - No other severe concurrent disease that would preclude study or interfere significantly with interpreting potential drug-induced toxic effects - No other active malignancy except nonmelanoma skin cancer - No concurrent serious immunocompromised status unless related to concurrent steroids - HIV-positive patients allowed - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 6 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy - At least 2 weeks since prior biologic noncytotoxic agents (e.g., thalidomide or interferon) - No concurrent biologic therapy or immunotherapy for brain cancer Chemotherapy - No prior interstitial chemotherapy, including carmustine wafers, unless separate lesion seen on MRI outside of prior treatment field - No more than 1 prior chemotherapy regimen for recurrent disease - At least 2 weeks since prior vincristine - At least 4 weeks since other prior chemotherapy (6 weeks for nitrosoureas) - No concurrent chemotherapy for brain cancer Endocrine therapy - At least 2 weeks since prior tamoxifen - Concurrent corticosteroids allowed if dose stable for at least 1 week prior to study entry - No concurrent hormonal therapy for brain cancer Radiotherapy - See Disease Characteristics - At least 12 weeks since prior radiotherapy - No prior stereotactic radiosurgery or interstitial brachytherapy unless separate lesion seen on MRI outside of prior treatment field - No concurrent radiotherapy for brain cancer Surgery - See Disease Characteristics - At least 2 weeks since prior surgery for initial or progressive disease and recovered - No concurrent surgery for brain cancer Other - At least 2 weeks since prior isotretinoin - At least 4 weeks since prior investigational agents - No concurrent therapeutic warfarin - No other concurrent investigational or noninvestigational therapy for brain cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KurtJaeckle, Study Chair, Mayo Clinic
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids, Iowa, 52403-1206
United States
Recruiting Martin Wiesenfeld 319-363-8303
Siouxland Hematology-Oncology *Recruiting*
Sioux City, Iowa, 51101-1733
United States
Recruiting Donald Wender 712-252-0088
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Steven Alberts 507-284-2511
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
Mayo Clinic *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting Kurt Jaeckle 904-953-7102
Additional Information:
Study ID Numbers: CDR0000257812; NCCTG-N0272
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049127
Other Adult Anaplastic Oligodendroglioma Studies:
1. Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma
2. Temozolomide and O6-benzylguanine in Treating Patients With Newly Diagnosed, Recurrent, or Progressive Anaplastic Glioma
3. Imatinib Mesylate in Treating Patients With Recurrent Brain Tumor
Related Studies:
Other adult anaplastic oligodendroglioma Clinical Trials
Other Minnesota Clinical Trials
Other Rochester Clinical Trials
Imatinib Mesylate in Treating Patients With Recurrent Brain Tumor
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