Status:
COMPLETED
Tumor Tissue Analysis in Patients Receiving Imatinib Mesylate for Malignant Glioma
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief Summary
RATIONALE: Collecting samples of tumor tissue and blood from patients with cancer to study in the laboratory may help doctors learn how patients respond to treatment. PURPOSE: This clinical trial is ...
Detailed Description
OBJECTIVES: Primary * Determine the efficacy, of imatinib mesylate, in terms of achieving a therapeutic tumor:plasma concentration ratio, in patients with primary malignant glioma. Secondary * Cor...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed malignant glioma of 1 of the following subtypes:
- Low-grade glioma
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Glioblastoma multiforme
- Unifocal disease that is progressive or recurrent after prior radiotherapy and/or chemotherapy
- Scheduled to undergo surgical resection
- Able to undergo maximal surgical resection of tumor mass
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Mini Mental Status Exam ≥ 15
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine ≥ 1.7 mg/dL
- BUN ≤ 2 times upper limit of normal (ULN)
- Transaminases ≤ 4 times ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment
- No other medical illness that would preclude study treatment, including any of the following:
- Serious infection
- Uncontrolled hypertension
- Unstable angina pectoris
- Uncontrolled cardiac dysrhythmia
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from all prior therapy
- At least 4 weeks since prior investigational drugs
- No more than 1 prior chemotherapy regimen
- No concurrent chemotherapy, biologic therapy, or radiotherapy
- No concurrent medications that may interact with imatinib mesylate or interfere with hepatic cytochrome P450 system
Exclusion
Key Trial Info
Start Date :
October 12 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2008
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00401024
Start Date
October 12 2006
End Date
November 11 2008
Last Update
June 28 2018
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410