Clinical Trial: Bafetinib in Treating Patients With Recurrent High-Grade Glioma or Brain Metastases

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: BAFETINIB-P1-GBM-01: A Pilot Study Using Intracerebral Microdialysis to Determine the Neuropharmacokinetics of Bafetinib in Patients With Recurrent Brain Tumors

Brief Summary:

RATIONALE: Bafetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This clinical trial studies bafetinib in treating patients with recurrent high-grade glioma or brain metastases.


Detailed Summary:

PRIMARY OBJECTIVES:

I. To determine the neuropharmacokinetics (nPK) and systemic levels of bafetinib in patients with recurrent malignant brain tumors.

SECONDARY OBJECTIVES:

I. To investigate the intrapatient variability of nPK parameters as assessed by intracerebral microdialysis.

II. To document the toxicity of bafetinib in this cohort of patients. III. To describe the response rate, progression-free survival, and overall survival in patients with malignant brain tumors treated with bafetinib.

IV. To assess for the expression of Lyn and Fyn kinases and phosphorylation status in pre-treatment tumor samples.

OUTLINE:Patients undergo intracerebral microdialysis during debulking craniotomy or stereotactic biopsy. Beginning 24 hours later, patients receive oral bafetinib twice daily for 1 day. Beginning at least 2 weeks after craniotomy or 1 week after biopsy, patients continue to receive oral bafetinib twice daily in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days and then every 8 weeks thereafter.


Sponsor: City of Hope Medical Center

Current Primary Outcome:

  • Area-under-the-concentration-time-curve (AUC) of bafetinib in dialysate [ Time Frame: every hour for 24 hours after first dose of bafetinib ]
  • Peak concentration (Cmax) of bafetinib in dialysate [ Time Frame: every hour for 24 hours after first dose of bafetinib ]
  • AUC of bafetinib in plasma [ Time Frame: 1, 2, 3, 4, 6, 8, and 12 hours after the first dose of bafetinib and then 1, 2, 3, 4, 6, 8, and 12 hours after the second dose of bafetinib ]
  • Cmax of bafetinib in plasma [ Time Frame: 1, 2, 3, 4, 6, 8, and 12 hours after the first dose of bafetinib and then 1, 2, 3, 4, 6, 8, and 12 hours after the second dose of bafetinib ]


Original Primary Outcome:

  • Determination of area-under-the-concentration-time-curve (AUC) and peak concentration (Cmax) of bafetinib in dialysate [ Time Frame: every hour for 24 hours after first dose of bafetinib ]
  • Determination of AUC and Cmax of bafetinib in plasma [ Time Frame: 1, 2, 3, 4, 6, 8, and 12 hours after the first dose of bafetinib and then 1, 2, 3, 4, 6, 8, and 12 hours after the second dose of bafetinib ]


Current Secondary Outcome:

  • Determination of adverse events associated with bafetinib in patient with recurrent malignant brain tumors [ Time Frame: 30 days after last dose of bafetinib ]
  • Response rate in patients with malignant brain tumors treated with bafetinib [ Time Frame: 30 days after last dose of bafetinib ]
  • Progression-free survival in patients with malignant brain tumors treated with bafetinib [ Time Frame: 1 year after last dose of bafetinib ]
  • Overall survival in patients with malignant brain tumors treated with bafetinib [ Time Frame: 2 years after last dose of bafetinib ]
  • Assessment for expression of Lyn and Fyn kinases and phosphorylation status in pre-treatment tumor samples. [ Time Frame: Pre-treatment tumor samples ]


Original Secondary Outcome: Same as current

Information By: City of Hope Medical Center

Dates:
Date Received: September 28, 2010
Date Started: December 2010
Date Completion:
Last Updated: March 18, 2013
Last Verified: March 2013