Imatinib Mesylate in Treating Patients With Gliomas
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: imatinib mesylate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Open Label Phase II Study On STI571 (Glivec) Administered As A Daily Oral Treatment In Gliomas |
| Enrollment: | 112 |
| Study Start Date: | March 2002 |
| Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Austria | |
| Kaiser Franz Josef Hospital | |
| Vienna, Austria, A-1100 | |
| Belgium | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| France | |
| Centre de Lutte Contre le Cancer, Georges-Francois Leclerc | |
| Dijon, France, 21079 | |
| CRLCC Nantes - Atlantique | |
| Nantes-Saint Herblain, France, 44805 | |
| Centre Antoine Lacassagne | |
| Nice, France, 06189 | |
| Institut Gustave Roussy | |
| Villejuif, France, F-94805 | |
| Italy | |
| Azienda Ospedaliera di Padova | |
| Padova, Italy, 35100 | |
| Netherlands | |
| Daniel Den Hoed Cancer Center at Erasmus Medical Center | |
| Rotterdam, Netherlands, 3008 AE | |
| Switzerland | |
| Centre Hospitalier Universitaire Vaudois | |
| Lausanne, Switzerland, CH-1011 | |
| United Kingdom | |
| Beatson Oncology Centre | |
| Glasgow, Scotland, United Kingdom, G11 6NT | |
| Study Chair: | Eric Raymond, MD, PhD | Institut Gustave Roussy |
| Study Chair: | Martin J. van Den Bent, MD | Daniel Den Hoed Cancer Center at Erasmus Medical Center |
More Information
Additional Information:
Publications:
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00039364 History of Changes |
| Other Study ID Numbers: | EORTC-16011-26013, EORTC-16011, EORTC-26013 |
| Study First Received: | June 6, 2002 |
| Last Updated: | July 23, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
recurrent adult brain tumor adult glioblastoma adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult mixed glioma |
adult pilocytic astrocytoma adult subependymoma adult giant cell glioblastoma adult gliosarcoma adult diffuse 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 21, 2013