Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: Imatinib Mesylate in Treating Patients With Gliomas

Summary: RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and slow the growth of the tumor.
  PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have gliomas.

Detailed description: OBJECTIVES:
  -  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.

Eligibility: DISEASE CHARACTERISTICS:
  -  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
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  ECOG 0-2
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Neutrophil count at least 2,000/mm^3
  -  Platelet count at least 100,000/mm^3
  Hepatic:
  -  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
  Renal:
  -  Creatinine less than 1.7 mg/dL
  Cardiovascular:
  -  Cardiac function normal
  -  No ischemic heart disease within the past 6 months
  -  Normal 12-lead ECG
  Other:
  -  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
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  No concurrent anticancer biologic agents
  -  No concurrent cytokines (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])
  Chemotherapy:
  -  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
  Radiotherapy:
  -  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
  Surgery:
  -  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
  Other:
  -  No concurrent warfarin or other anticoagulants
  -  No other concurrent anticancer agents
  -  No other concurrent investigational agents

Relevance to patient case: not relevant