Status:
COMPLETED
Imatinib Mesylate and Temozolomide in Treating Patients With Malignant Glioma
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop...
Detailed Description
OBJECTIVES: * Determine the maximum tolerated dose and dose-limiting toxicity, if attainable, of imatinib mesylate in combination with temozolomide in patients with malignant glioma. * Characterize t...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed malignant glioma
- Any of the following subtypes:
- Glioblastoma multiforme
- Gliosarcoma
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Anaplastic oligoastrocytoma
- Previous histologic diagnosis of a lower grade of glioma allowed if there is histologic evidence of progression to a diagnosis of malignant glioma
- Multifocal disease allowed
- Must have undergone prior conventional external-beam radiation therapy
- Stable disease, disease recurrence, or relapsed disease
- Must not have received any systemic therapy for this recurrence or relapse
- No prior progressive disease
- No central/systemic fluid collections (pericardial effusion, pulmonary effusion, ascites) ≥ grade 2
- No evidence of intratumor hemorrhage on pretreatment diagnostic imaging, except for stable post-operative grade 1 hemorrhage
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Absolute neutrophil count \> 1,500/mm³
- Hemoglobin \> 9 g/dL
- Platelet count \> 100,000/mm³
- AST and ALT \< 2.5 times upper limit of normal (ULN)
- Bilirubin \< 1.5 times ULN
- Creatinine \< 1.5 times ULN
- No chronic renal disease
- No active uncontrolled infection
- No uncontrolled diabetes
- No excessive risk of bleeding, as defined by occurrence of any of the following:
- Stroke within the past 6 months
- History of CNS or intraocular bleed
- Septic endocarditis
- No history of labile hypertension
- No congestive heart failure
- No poorly controlled hypertension
- No myocardial infarction within the past 6 months
- No history of poor compliance with antihypertensive regimen
- No other severe and/or uncontrolled medical disease that would preclude study participation
- No peripheral edema ≥ grade 2
- No gastrointestinal bleeding
- No gross hematuria
- No other active systemic bleeding
- Patients must not have experienced toxicity ≥ grade 3 with prior treatment with either temozolomide or imatinib mesylate
- No other primary malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix or other cancer not currently clinically significant nor requiring active interventions
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from all prior therapy
- Prior surgical resection(s) allowed
- At least 2 weeks since prior surgery
- At least 2 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- At least 2 weeks since prior external-beam radiotherapy
- At least 2 weeks since prior investigational drugs
- More than 1 week since prior biologic, immunotherapeutic, or cytostatic agents
- No concurrent warfarin
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00354068
Start Date
July 1 2004
End Date
November 1 2008
Last Update
March 28 2013
Active Locations (1)
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1
Duke Cancer Institute
Durham, North Carolina, United States, 27710