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Brain and Central Nervous System TumorsPhase 1NCT00354068

Imatinib Mesylate and Temozolomide in Treating Patients With Malignant Glioma

A Phase 1 study testing imatinib mesylate, temozolomide and pharmacological study in people with Brain and Central Nervous System Tumors, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
imatinib mesylate, temozolomide and pharmacological study
How many people
65 participants
Where
1 siteUnited States
Study dates
Jul 2004to 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant glioma
  • Any of the following subtypes:
  • Glioblastoma multiforme
  • Gliosarcoma
  • Anaplastic astrocytoma
  • Anaplastic oligodendroglioma
  • Anaplastic oligoastrocytoma
  • Previous histologic diagnosis of a lower grade of glioma allowed if there is histologic evidence of progression to a diagnosis of malignant glioma
  • Multifocal disease allowed
  • Must have undergone prior conventional external-beam radiation therapy
  • Stable disease, disease recurrence, or relapsed disease
  • Must not have received any systemic therapy for this recurrence or relapse
  • No prior progressive disease
  • No central/systemic fluid collections (pericardial effusion, pulmonary effusion, ascites) ≥ grade 2
  • No evidence of intratumor hemorrhage on pretreatment diagnostic imaging, except for stable post-operative grade 1 hemorrhage

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • Absolute neutrophil count > 1,500/mm³
  • Hemoglobin > 9 g/dL
  • Platelet count > 100,000/mm³
  • AST and ALT < 2.5 times upper limit of normal (ULN)
  • Bilirubin < 1.5 times ULN
  • Creatinine < 1.5 times ULN
  • No chronic renal disease
  • No active uncontrolled infection
  • No uncontrolled diabetes
  • No excessive risk of bleeding, as defined by occurrence of any of the following:
  • Stroke within the past 6 months
  • History of CNS or intraocular bleed
  • Septic endocarditis
  • No history of labile hypertension
  • No congestive heart failure
  • No poorly controlled hypertension
  • No myocardial infarction within the past 6 months
  • No history of poor compliance with antihypertensive regimen
  • No other severe and/or uncontrolled medical disease that would preclude study participation
  • No peripheral edema ≥ grade 2
  • No gastrointestinal bleeding
  • No gross hematuria
  • No other active systemic bleeding
  • Patients must not have experienced toxicity ≥ grade 3 with prior treatment with either temozolomide or imatinib mesylate
  • No other primary malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix or other cancer not currently clinically significant nor requiring active interventions

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from all prior therapy
  • Prior surgical resection(s) allowed
  • At least 2 weeks since prior surgery
  • At least 2 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  • At least 2 weeks since prior external-beam radiotherapy
  • At least 2 weeks since prior investigational drugs
  • More than 1 week since prior biologic, immunotherapeutic, or cytostatic agents
  • No concurrent warfarin

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke Cancer Institute

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: A Phase I Study of Imatinib Mesylate in Combination With Temozolomide in Patients With Malignant Glioma

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving imatinib mesylate together with temozolomide may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate when given together with temozolomide in treating patients with malignant glioma.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose and dose-limiting toxicity, if attainable, of imatinib mesylate in combination with temozolomide in patients with malignant glioma.
  • Characterize the safety and tolerability of imatinib mesylate, including acute and chronic toxicities, in these patients.
  • Determine the effect of temozolomide on the pharmacokinetics (PK) of imatinib mesylate at each dose level.
  • Evaluate the impact of enzyme-inducing anti-epileptic drug (EIAED) coadministration on the PK of imatinib mesylate using a population-based PK approach.
  • Evaluate the antitumor activity of imatinib mesylate plus temozolomide.

OUTLINE: This is a dose-escalation study of imatinib mesylate. Patients are stratified according to concurrent enzyme-inducing anticonvulsants (e.g., phenytoin, phenobarbital, carbamazepine, fosphenytoin, primidone, oxcarbazepine) (yes vs no).

Patients receive oral imatinib mesylate once or twice daily on days 1-8 and oral temozolomide once daily on days 4-8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of patients receive escalating doses of imatinib mesylate until the maximum tolerated dose is determined.

On days 1 and 8 of course 1, blood is drawn for pharmacokinetic studies.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Being tested
imatinib mesylate, temozolomide, pharmacological study
Keywords
adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma, adult mixed glioma, adult anaplastic astrocytoma, recurrent adult brain tumor, adult glioblastoma
Medical subject headings
Central Nervous System Neoplasms, Oligodendroglioma, Glioblastoma, Gliosarcoma, Glioma, Astrocytoma, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose

  2. Dose-limiting toxicity

  3. Safety and tolerability

  4. Pharmacokinetics

  5. Anti-tumor activity

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2006 (estimated)
  2. Study startJul 2004
  3. Primary completionNov 2008
  4. Study completionNov 2008

Resources

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
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00354068
Sponsor's protocol ID
Pro00004364
Other IDs
DUMC-5514-06-1R2, NOVARTIS-DUMC-5514-06-1R2, CDR0000483760
Status last verified
Mar 2013
First submitted
19 Jul 2006
Last updated
28 Mar 2013
Results posted
No

Publications

  • Reardon DA, Desjardins A, Vredenburgh JJ, Sathornsumetee S, Rich JN, Quinn JA, Lagattuta TF, Egorin MJ, Gururangan S, McLendon R, Herndon JE 2nd, Friedman AH, Salvado AJ, Friedman HS. Safety and pharmacokinetics of dose-intensive imatinib mesylate plus temozolomide: phase 1 trial in adults with malignant glioma. Neuro Oncol. 2008 Jun;10(3):330-40. doi: 10.1215/15228517-2008-003. Epub 2008 Mar 21.

    PubMed 18359865

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing imatinib mesylate, temozolomide and pharmacological study in people with Brain and Central Nervous System Tumors, run by Duke University 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 Mar 2013. 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?

Maximum tolerated dose. The study lists 5 primary outcomes in all. 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 NCT00354068, 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 Mar 2013.

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