Brain and Central Nervous System TumorsPhase 1NCT00401024
Tumor Tissue Analysis in Patients Receiving Imatinib Mesylate for Malignant Glioma
A Phase 1 study testing imatinib mesylate, pharmacological study and conventional surgery in people with Brain and Central Nervous System Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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 looking at tumor tissue samples from patients receiving imatinib mesylate for malignant glioma to see how much imatinib… 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, pharmacological study and conventional surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2006to 11 Nov 2008
- Phase
- Phase 1
- 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 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
About this study
Official title: Determination of the In-Tumor-Concentration of Imatinib Mesylate in Malignant Glioma After Oral Administration
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.
Read the 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
- 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.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- imatinib mesylate, pharmacological study, conventional surgery
- Keywords
- 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
- Medical subject headings
- Central Nervous System Neoplasms, Oligodendroglioma, Astrocytoma, Glioblastoma, Gliosarcoma, Brain Neoplasms, Glioma, Ependymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imatinib mesylateDrug
conventional surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Imatinib mesylate 600mg orally once a day for seven consecutive days prior to surgery with last dose taken one day prior to surgery Receives: Drug: imatinib mesylate; Other: pharmacological study; Procedure: conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor:plasma concentration ratio of imatinib mesylate
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2006 (estimated)
- Study start12 Oct 2006
- Primary completion4 Feb 2008
- Study completion11 Nov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stuart A. Grossman, MD, Study chair, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00401024
- Sponsor's protocol ID
- J0623
- Other IDs
- P30CA006973, CDR0000510133, NA_00001201
- Status last verified
- Jun 2018
- First submitted
- 16 Nov 2006
- Last updated
- 28 Jun 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Holdhoff M, Supko JG, Gallia GL, Hann CL, Bonekamp D, Ye X, Cao B, Olivi A, Grossman SA. Intratumoral concentrations of imatinib after oral administration in patients with glioblastoma multiforme. J Neurooncol. 2010 Apr;97(2):241-5. doi: 10.1007/s11060-009-0008-0. Epub 2009 Sep 19.
PubMed 19768386
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the In-Tumor-Concentration of Imatinib Mesylate in Malignant Glioma After Oral Administration
- ClinicalTrials.gov ID
- NCT00401024
- Acronym / sponsor ID
- J0623
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 Oct 2006 (actual)
- Primary completion
- 4 Feb 2008 (actual)
- Study completion
- 11 Nov 2008 (actual)
- First posted
- 17 Nov 2006 (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: 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.
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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: imatinib mesylate, Other: pharmacological study, Procedure: conventional surgeryImatinib mesylate 600mg orally once a day for seven consecutive days prior to surgery with last dose taken one day prior to surgery |
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 | Treatment |
| pharmacological study | Other | Treatment |
| conventional surgery | Procedure or surgery | Treatment |
Primary outcome
Tumor:plasma concentration ratio of imatinib mesylate
Time frame: 2 weeks
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 28 Jun 2018.
- Results publication: PubMed 19768386Holdhoff M, Supko JG, Gallia GL, Hann CL, Bonekamp D, Ye X, Cao B, Olivi A, Grossman SA. Intratumoral concentrations of imatinib after oral administration in patients with glioblastoma multiforme. J Neurooncol. 2010 Apr;97(2):241-5. doi: 10.1007/s11060-009-0008-0. Epub 2009 Sep 19.
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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.
Stuart A. Grossman, MD study chair
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing imatinib mesylate, pharmacological study and conventional surgery in people with Brain and Central Nervous System Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site 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 28 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 1 site 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 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.
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.
What does the primary outcome measure?
Tumor:plasma concentration ratio of imatinib mesylate (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00401024, which also lists 1 linked publication.
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 28 Jun 2018.