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Open Label Phase II Study On STI571 (Glivec) Administered As A Daily Oral Treatment In Gliomas

Phase 2
18 Years
Not Enrolling
Brain and Central Nervous System Tumors

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Trial Information

Open Label Phase II Study On STI571 (Glivec) Administered As A Daily Oral Treatment In Gliomas


- Determine the therapeutic activity of imatinib mesylate (in terms of objective response
and progression-free survival at 6 months) in patients with gliomas.

- Determine the safety of this drug in these patients.

- Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to glioma
(glioblastoma multiforme vs anaplastic oligodendroglioma or mixed oligoastrocytoma vs
anaplastic astrocytoma or recurrent low-grade astrocytoma).

Patients receive oral imatinib mesylate once or twice daily. Treatment repeats every 4 weeks
for up to 9 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 6 months and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 77 patients (29 patients with glioblastoma multiforme, 24
patients with anaplastic oligodendroglioma or mixed oligoastrocytoma, and 24 patients with
anaplastic astrocytoma or recurrent low-grade astrocytoma) will be accrued for this study.

Inclusion Criteria


- Histologically or cytologically confirmed glioblastoma multiforme

- Recurrent disease by CT scan or MRI

- No prior chemotherapy OR

- No more than 1 prior chemotherapy regimen in adjuvant setting or for recurrent
disease OR

- Histologically or cytologically confirmed anaplastic oligodendroglioma, mixed
oligoastrocytoma, anaplastic astrocytoma, or recurrent low-grade astrocytoma

- Failed prior radiotherapy

- No more than 1 prior chemotherapy regimen

- Failed adjuvant chemotherapy OR

- Failed first-line chemotherapy

- At least 1 bidimensionally measurable target lesion

- At least 2 cm on contrast-enhanced CT scan or MRI



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified


- Neutrophil count at least 2,000/mm^3

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


- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST and ALT no greater than 2.5 times ULN

- Alkaline phosphatase no greater than 2.5 times ULN


- Creatinine less than 1.7 mg/dL


- Cardiac function normal

- No ischemic heart disease within the past 6 months

- Normal 12-lead ECG


- No other prior or concurrent malignancy except cone-biopsied carcinoma of the cervix
or adequately treated basal cell or squamous cell skin cancer

- No unstable systemic disease

- No active uncontrolled infection

- No psychological, familial, sociological, or geographical condition that would
preclude study compliance

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after study


Biologic therapy:

- No concurrent anticancer biologic agents

- No concurrent cytokines (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])


- See Disease Characteristics

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

- No concurrent chemotherapy

Endocrine therapy:

- Must be on stable or decreasing dose of corticosteroids for at least 2 weeks


- See Disease Characteristics

- At least 3 months since prior brain irradiation

- No prior high-dose radiotherapy (more than 65 Gy), stereotactic radiosurgery, or
internal radiotherapy unless the recurrence is histologically confirmed

- No concurrent radiotherapy


- Prior surgery for primary brain tumor within the past 3 months allowed provided one
of the following conditions are present:

- Postoperative imaging within 72 hours after surgery shows a clearly limited
target lesion of at least 2 cm

- Postoperative follow-up shows a progressive and measurable target lesion

- A second measurable target lesion is present outside the surgical area


- No concurrent warfarin or other anticoagulants

- No other concurrent anticancer agents

- No other concurrent investigational agents

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Eric Raymond, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris


United States: Federal Government

Study ID:




Start Date:

March 2002

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult mixed glioma
  • adult pilocytic astrocytoma
  • adult subependymoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • adult diffuse astrocytoma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms