Brain and Central Nervous System TumorsPhase 1/2NCT00010049
Imatinib Mesylate in Treating Patients With Recurrent Malignant Glioma or Meningioma
A Phase 1/2 study testing imatinib mesylate in people with Brain and Central Nervous System Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 11 sites in United States.
Trial summary
RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and may be an effective treatment for recurrent glioma and meningioma. PURPOSE: Phase I/II trial to study the effectiveness of imatinib mesylate in treating patients who have progressive, recurrent, or unresectable malignant glioma or meningioma. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- imatinib mesylate
- How many people
- 105 participants
- Where
- 11 sitesUnited States
- Study dates
- 27 Feb 2001to 15 Aug 2006
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed recurrent or unresectable malignant glioma
- Glioblastoma multiforme (phase I only)
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Anaplastic mixed oligoastrocytoma
- Malignant astrocytoma not otherwise specified
- Gliosarcoma
- Low-grade histology with subsequent diagnosis of malignant glioma allowed (phase I only) OR
- Histologically confirmed recurrent or unresectable benign or malignant meningioma (phase I only)
- No prior intracranial hemorrhage
- Failed prior radiotherapy
- Progressive or recurrent disease by MRI or CT scan and/or resection
- PET or thallium scan, MR spectroscopy, or surgical documentation required in patients who have received prior interstitial brachytherapy or stereotactic radiosurgery
- Stable dose of steroids for 5-7 days prior to MRI or CT scan
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- More than 8 weeks
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL (transfusion allowed)
Hepatic:
- Bilirubin less than 2 times upper limit of normal (ULN)
- SGOT less than 2 times ULN
- No significant hepatic disease
Renal:
- Creatinine less than 1.5 mg/dL
- Creatinine clearance at least 60 mL/min
- No significant renal disease
Cardiovascular:
- No significant cardiac disease
- No deep venous or arterial thrombosis within the past 6 weeks
Pulmonary:
- No pulmonary embolism within the past 6 weeks
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for up to 6 months after study participation
- No other serious concurrent medical illness
- No serious active infection
- No concurrent disease that would obscure toxicity or alter drug metabolism
- No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 1 week since prior interferon or thalidomide and recovered
- No concurrent immunotherapy
- No concurrent prophylactic filgrastim (G-CSF)
Chemotherapy:
- Recovered from prior chemotherapy
- At least 4 weeks since prior cytotoxic therapy
- At least 2 weeks since prior vincristine
- At least 6 weeks since prior nitrosoureas
- At least 4 weeks since prior temozolomide
- At least 3 weeks since prior procarbazine
- Prior polifeprosan 20 with carmustine implant (Gliadel wafer) allowed
- Prior radiosensitizers allowed
- No other concurrent chemotherapy
- Phase I only:
- Prior chemotherapy required for anaplastic astrocytoma, anaplastic oligodendroglioma, and anaplastic mixed oligoastrocytoma
- Prior treatment for up to 3 relapses allowed
- Phase II only:
- Prior chemotherapy not required
- Prior treatment for up to 2 relapses allowed
Endocrine therapy:
- See Disease Characteristics
- At least 1 week since prior tamoxifen and recovered
- No concurrent anticancer hormonal therapy
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- Recovered from prior surgical resection of recurrent or progressive disease
Other:
- At least 1 week since prior non-cytotoxic agents and recovered
- At least 1 week since prior tretinoin and recovered
- At least 2 weeks since prior drugs that affect hepatic metabolism
- No other concurrent investigational agents
- No concurrent warfarin
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0316
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390-9154
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-6220
UCSF Comprehensive Cancer Center
San Francisco, California, 94143-0128
About this study
Official title: Phase I/II Trial of STI571 (NSC 716051) in Patients With Recurrent Malignant Gliomas
RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and may be an effective treatment for recurrent glioma and meningioma.
PURPOSE: Phase I/II trial to study the effectiveness of imatinib mesylate in treating patients who have progressive, recurrent, or unresectable malignant glioma or meningioma.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of imatinib mesylate in patients with recurrent malignant glioma or meningioma.
- Determine the safety profile of this drug in these patients.
- Determine the pharmacokinetics of this drug, with or without concurrent enzyme-inducing anti-epileptic drugs (EIAEDs), in these patients. (Stratum of patients currently taking EIAEDs closed to accrual as of 05/15/2003 for phase I and phase II)
- Determine angiogenic activity in vivo using functional neuro-imaging studies and in vitro with assays of serum angiogenic peptides.
- Determine the efficacy of this drug, in terms of 6-month progression-free survival and objective tumor response, in these patients.
OUTLINE: This is a multicenter, dose-escalation study. Patients are stratified according to concurrent enzyme-inducing anti-epileptic drug use (yes [stratum closed to accrual as of 05/15/2003 for phase I and phase II] vs no).
- Phase I (patients with glioma or meningioma) Patients in cohorts 1 and 2 receive oral imatinib mesylate (STI571) once daily on days 1-28. Patients in cohorts 3-5 receive oral STI571 twice daily on days 1 and 3-28 of the first course and on days 1-28 of subsequent courses. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of STI571 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Phase II (patients with glioma) (glioblastoma multiforme patients excluded as of 05/15/2003) Patients receive oral STI571 at the MTD determined in phase I, 1-2 times daily for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for phase I of the study within 6 months and a total of 39 patients will be accrued for phase II of the study within 6-8 months. (Glioblastoma multiforme patients excluded from phase II as of 05/13/2003).
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- imatinib mesylate
- Keywords
- recurrent adult brain tumor, adult meningioma, adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult pilocytic astrocytoma, adult subependymoma, adult grade III meningioma, adult giant cell glioblastoma, adult gliosarcoma
- Medical subject headings
- Central Nervous System Neoplasms, Brain Neoplasms, Meningioma, Glioblastoma, Astrocytoma, Oligodendroglioma, Glioma, Glioma, Subependymal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imatinib mesylateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study start27 Feb 2001
- Primary completion17 Mar 2005
- Study completion15 Aug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Patrick Y. Wen, MD, Study chair, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00010049
- Sponsor's protocol ID
- NABTC-9908
- Other IDs
- CDR0000068437, NCI-01-C-0243, UCLA-0101024
- Status last verified
- Jun 2018
- First submitted
- 2 Feb 2001
- Last updated
- 27 Jun 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Wen PY, Yung WK, Lamborn KR, Dahia PL, Wang Y, Peng B, Abrey LE, Raizer J, Cloughesy TF, Fink K, Gilbert M, Chang S, Junck L, Schiff D, Lieberman F, Fine HA, Mehta M, Robins HI, DeAngelis LM, Groves MD, Puduvalli VK, Levin V, Conrad C, Maher EA, Aldape K, Hayes M, Letvak L, Egorin MJ, Capdeville R, Kaplan R, Murgo AJ, Stiles C, Prados MD. Phase I/II study of imatinib mesylate for recurrent malignant gliomas: North American Brain Tumor Consortium Study 99-08. Clin Cancer Res. 2006 Aug 15;12(16):4899-907. doi: 10.1158/1078-0432.CCR-06-0773.
PubMed 16914578Wen PY, Yung WKA, Lamborn K, et al.: Phase I/II study of imatinib mesylate (ST1571) for patients with recurrent malignant gliomas (NABTC 99-08). [Abstract] Neuro-Oncology 6 (4): TA-63, 385, 2004.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial of STI571 (NSC 716051) in Patients With Recurrent Malignant Gliomas
- ClinicalTrials.gov ID
- NCT00010049
- Acronym / sponsor ID
- NABTC-9908
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- recurrent adult brain tumor, adult meningioma, adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult pilocytic astrocytoma, adult subependymoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Feb 2001 (actual)
- Primary completion
- 17 Mar 2005 (actual)
- Study completion
- 15 Aug 2006 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and may be an effective treatment for recurrent glioma and meningioma.
PURPOSE: Phase I/II trial to study the effectiveness of imatinib mesylate in treating patients who have progressive, recurrent, or unresectable malignant glioma or meningioma.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of imatinib mesylate in patients with recurrent malignant glioma or meningioma.
- Determine the safety profile of this drug in these patients.
- Determine the pharmacokinetics of this drug, with or without concurrent enzyme-inducing anti-epileptic drugs (EIAEDs), in these patients. (Stratum of patients currently taking EIAEDs closed to accrual as of 05/15/2003 for phase I and phase II)
- Determine angiogenic activity in vivo using functional neuro-imaging studies and in vitro with assays of serum angiogenic peptides.
- Determine the efficacy of this drug, in terms of 6-month progression-free survival and objective tumor response, in these patients.
OUTLINE: This is a multicenter, dose-escalation study. Patients are stratified according to concurrent enzyme-inducing anti-epileptic drug use (yes [stratum closed to accrual as of 05/15/2003 for phase I and phase II] vs no).
- Phase I (patients with glioma or meningioma) Patients in cohorts 1 and 2 receive oral imatinib mesylate (STI571) once daily on days 1-28. Patients in cohorts 3-5 receive oral STI571 twice daily on days 1 and 3-28 of the first course and on days 1-28 of subsequent courses. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of STI571 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Phase II (patients with glioma) (glioblastoma multiforme patients excluded as of 05/15/2003) Patients receive oral STI571 at the MTD determined in phase I, 1-2 times daily for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for phase I of the study within 6 months and a total of 39 patients will be accrued for phase II of the study within 6-8 months. (Glioblastoma multiforme patients excluded from phase II as of 05/13/2003).
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| imatinib mesylate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- Results publication: PubMed 16914578Wen PY, Yung WK, Lamborn KR, Dahia PL, Wang Y, Peng B, Abrey LE, Raizer J, Cloughesy TF, Fink K, Gilbert M, Chang S, Junck L, Schiff D, Lieberman F, Fine HA, Mehta M, Robins HI, DeAngelis LM, Groves MD, Puduvalli VK, Levin V, Conrad C, Maher EA, Aldape K, Hayes M, Letvak L, Egorin MJ, Capdeville R, Kaplan R, Murgo AJ, Stiles C, Prados MD. Phase I/II study of imatinib mesylate for recurrent malignant gliomas: North American Brain Tumor Consortium Study 99-08. Clin Cancer Res. 2006 Aug 15;12(16):4899-907. doi: 10.1158/1078-0432.CCR-06-0773.
- Results publicationWen PY, Yung WKA, Lamborn K, et al.: Phase I/II study of imatinib mesylate (ST1571) for patients with recurrent malignant gliomas (NABTC 99-08). [Abstract] Neuro-Oncology 6 (4): TA-63, 385, 2004.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Y. Wen, MD study chair
Dana-Farber Cancer Institute
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing imatinib mesylate in people with Brain and Central Nervous System Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00010049, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2018.