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Phase I/II Trial Of Imatinib Mesylate; (Gleevec; STI571) In Treatment Of Recurrent Oligodendroglioma And Mixed Oligoastrocytoma

Phase 1/Phase 2
18 Years
Open (Enrolling)
Adult Anaplastic Oligodendroglioma, Adult Mixed Glioma, Adult Oligodendroglioma, Recurrent Adult Brain Tumor

Thank you

Trial Information

Phase I/II Trial Of Imatinib Mesylate; (Gleevec; STI571) In Treatment Of Recurrent Oligodendroglioma And Mixed Oligoastrocytoma


I. Determine the maximum tolerated dose of imatinib mesylate in patients with recurrent
oligodendroglioma or mixed oligoastrocytoma who are currently on enzyme-inducing
anticonvulsant therapy.

II. Determine the efficacy of imatinib mesylate, as measured by response, survival, and
progression-free survival, in patients with recurrent oligodendroglioma or mixed

III. Compare pilot data of patients who have undergone > 2 prior chemotherapy regimens for
recurrent, progressive, or mixed oligodendroglioma with traditional patients with recurrent
or mixed oligodendroglioma.

IV. Determine the toxicity and safety of this drug in these patients. V. Correlate,
preliminarily, 1p/19q alterations, alpha-PDFGR gene amplification, and levels of related
downstream signaling elements in tumor tissue with clinical response in patients treated
with this drug.

OUTLINE: This is a multicenter, phase I, dose-escalation study followed by a phase II and a
pilot study.

PHASE I: Patients receive oral imatinib mesylate twice daily for 4 weeks. Courses repeat
every 4 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of imatinib mesylate 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.


mesylate, at the MTD determined in phase I, twice daily for 4 weeks.

GROUP 2 (NON-EIACs): Patients receive oral standard-dose imatinib mesylate twice daily for 4

In both groups, treatment repeats every 4 weeks in the absence of disease progression or
unacceptable toxicity.

PILOT STUDY: Patients are stratified and assigned to treatment groups as in phase II.
Patients receive oral imatinib as in phase II.

Patients are followed every 2 months.

Inclusion Criteria:

- Histologically confirmed oligodendroglioma or mixed oligoastrocytoma

- Grade 2-4

- Recurrent disease

- Patients with mixed gliomas must have > 25% oligodendrogliomatous component

- Failed prior surgery, radiotherapy, and temozolomide or nitrosourea-based therapy

- Progressive disease by MRI or CT scan

- Measurable or evaluable disease by MRI or CT scan

- More than 2 prior chemotherapy regimens for progressive or recurrent disease (pilot
study only)

- Currently taking anticonvulsants which can induce cytochrome p450 (e.g., phenytoin,
carbamazepine, barbiturates, or primidone (Phase I only)

- No prior or concurrent significant intratumoral hemorrhage

- Performance status - ECOG 0-2

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 9 g/dL

- Bilirubin no greater than 1.5 mg/dL

- AST no greater than 3 times upper limit of normal

- Creatinine no greater than 2.0 mg/dL

- No myocardial infarction within the past 6 months

- No congestive heart failure requiring maintenance therapy for life-threatening
ventricular arrhythmias

- No New York Heart Association class III or IV heart disease

- No active uncontrolled infection

- No other severe concurrent disease that would preclude study or interfere
significantly with interpreting potential drug-induced toxic effects

- No other active malignancy except nonmelanoma skin cancer

- No concurrent serious immunocompromised status unless related to concurrent steroids

- HIV-positive patients allowed

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after study

- At least 2 weeks since prior biologic noncytotoxic agents (e.g., thalidomide or

- No concurrent biologic therapy or immunotherapy for brain cancer

- No concurrent therapeutic warfarin or heparin

- Low-dose warfarin and heparin (1 mg daily) allowed

- No prior interstitial chemotherapy, including carmustine wafers, unless separate
lesion seen on MRI outside of prior treatment field

- At least 2 weeks since prior vincristine

- At least 4 weeks since other prior chemotherapy (6 weeks for nitrosoureas)

- No concurrent chemotherapy for brain cancer

- At least 2 weeks since prior tamoxifen

- Concurrent corticosteroids allowed if dose stable for at least 1 week prior to study

- No concurrent hormonal therapy for brain cancer

- At least 12 weeks since prior radiotherapy

- No prior stereotactic radiosurgery or interstitial brachytherapy unless separate
lesion seen on MRI outside of prior treatment field

- No concurrent radiotherapy for brain cancer

- No other concurrent investigational or noninvestigational therapy for brain cancer

- At least 2 weeks since prior surgery for initial or progressive disease and recovered

- No concurrent surgery for brain cancer

- At least 2 weeks since prior isotretinoin

- At least 4 weeks since prior investigational agents

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

MTD of imatinib mesylate when given to patients who are receiving EIACs, defined as the highest safely tolerated dose level where, at most, 1 of 6 patients experiences DLT, graded according to CTCAE v4.0 (Phase I)

Outcome Time Frame:

Up to 4 weeks

Safety Issue:


Principal Investigator

Kurt Jaeckle

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Central Cancer Treatment Group


United States: Food and Drug Administration

Study ID:




Start Date:

June 2003

Completion Date:

Related Keywords:

  • Adult Anaplastic Oligodendroglioma
  • Adult Mixed Glioma
  • Adult Oligodendroglioma
  • Recurrent Adult Brain Tumor
  • Brain Neoplasms
  • Glioma
  • Oligodendroglioma
  • Astrocytoma



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