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Imatinib Mesylate and Temozolomide in Treating Patients With Malignant Glioma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00354068
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Duke University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 David A. Reardon, MD
Principal Investigator Affiliation Duke Cancer Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors
Additional Details

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.#46;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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Duke Cancer Institute, Durham, North Carolina

Status

Address

Duke Cancer Institute

Durham, North Carolina, 27710

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