Tumor Tissue Analysis in Patients Receiving Imatinib Mesylate for Malignant Glioma

Johns Hopkins Medicine

Status and phase: Completed; Phase 1

Conditions: Brain and Central Nervous System Tumors

Treatments: Drug: imatinib mesylate; Procedure: conventional surgery; Other: pharmacological study

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00401024

P30CA006973 (U.S. NIH Grant/Contract)

J0623

NA_00001201 (Other Identifier)

CDR0000510133

Details and patient eligibility

About

RATIONALE: Collecting samples of tumor tissue and blood from patients with cancer to study in the laboratory may help doctors learn how patients respond to treatment.

PURPOSE: This clinical trial is looking at tumor tissue samples from patients receiving imatinib mesylate for malignant glioma to see how much imatinib mesylate is found in the tumor tissue.

Full description

OBJECTIVES:

Primary

• Determine the efficacy, of imatinib mesylate, in terms of achieving a therapeutic tumor:plasma concentration ratio, in patients with primary malignant glioma.

Secondary

• Correlate tumor grade (low vs high) and/or tumor enhancement on MRI with tumor concentration of this drug in these patients.,

OUTLINE: Patients receive oral imatinib mesylate once daily for 7-12 days. Patients then undergo surgical resection.

Blood and tissue samples are collected at the time of surgery and analyzed for imatinib mesylate concentration.

After completion of study treatment, patients are followed for 7 days.

PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

Enrollment: 3 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed malignant glioma of 1 of the following subtypes:

  • Low-grade glioma
  • Anaplastic astrocytoma
  • Anaplastic oligodendroglioma
  • Glioblastoma multiforme

• Unifocal disease that is progressive or recurrent after prior radiotherapy and/or chemotherapy

• Scheduled to undergo surgical resection

  • Able to undergo maximal surgical resection of tumor mass

PATIENT CHARACTERISTICS:

• Karnofsky performance status 70-100%

• Mini Mental Status Exam ≥ 15

• Absolute neutrophil count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Creatinine ≥ 1.7 mg/dL

• BUN ≤ 2 times upper limit of normal (ULN)

• Transaminases ≤ 4 times ULN

• Not pregnant or nursing

• Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment

• No other medical illness that would preclude study treatment, including any of the following:

  • Serious infection
  • Uncontrolled hypertension
  • Unstable angina pectoris
  • Uncontrolled cardiac dysrhythmia

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Recovered from all prior therapy
• At least 4 weeks since prior investigational drugs
• No more than 1 prior chemotherapy regimen
• No concurrent chemotherapy, biologic therapy, or radiotherapy
• No concurrent medications that may interact with imatinib mesylate or interfere with hepatic cytochrome P450 system

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Treatment

Experimental group

Description:

Imatinib mesylate 600mg orally once a day for seven consecutive days prior to surgery with last dose taken one day prior to surgery

Treatment:

Drug: imatinib mesylate

Other: pharmacological study

Procedure: conventional surgery