Tumor Tissue Analysis in Patients Receiving Imatinib Mesylate for Malignant Glioma
This study has been completed.
Sponsor:
Sidney Kimmel Comprehensive Cancer Center
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00401024
First received: November 16, 2006
Last updated: July 24, 2010
Last verified: July 2009
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Purpose
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 looking at tumor tissue samples from patients receiving imatinib mesylate for malignant glioma to see how much imatinib mesylate is found in the tumor tissue.
| Condition | Intervention |
|---|---|
|
Brain and Central Nervous System Tumors |
Drug: imatinib mesylate Other: pharmacological study Procedure: conventional surgery |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Determination of the In-Tumor-Concentration of Imatinib Mesylate in Malignant Glioma After Oral Administration |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Tumor:plasma concentration ratio of imatinib mesylate [ Designated as safety issue: No ]
| Estimated Enrollment: | 33 |
| Study Start Date: | July 2006 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
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
- Correlate tumor grade (low vs high) and/or tumor enhancement on MRI with tumor concentration of this drug in these patients.,
OUTLINE: Patients receive oral imatinib mesylate once daily for 7-12 days. Patients then undergo surgical resection.
Blood and tissue samples are collected at the time of surgery and analyzed for imatinib mesylate concentration.
After completion of study treatment, patients are followed for 7 days.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00401024
Locations
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
| Study Chair: | Stuart A. Grossman, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00401024 History of Changes |
| Other Study ID Numbers: | CDR0000510133, JHOC-J0623, JHOC-NA_00001201 |
| Study First Received: | November 16, 2006 |
| Last Updated: | July 24, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adult anaplastic oligodendroglioma adult oligodendroglioma adult anaplastic astrocytoma adult giant cell glioblastoma adult gliosarcoma recurrent adult brain tumor adult brain stem glioma adult mixed glioma adult glioblastoma |
adult pilocytic astrocytoma adult diffuse astrocytoma adult anaplastic ependymoma adult ependymoma adult myxopapillary ependymoma adult subependymoma adult pineal gland astrocytoma adult subependymal giant cell astrocytoma |
Additional relevant MeSH terms:
|
Glioma Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Neoplasms by Site Nervous System Diseases Imatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013