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

18 Years
Not Enrolling
Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma, Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Adult Mixed Glioma, Recurrent Adult Brain Tumor, Tumors Metastatic to Brain, Adult Anaplastic Oligoastrocytoma

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Trial Information

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


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


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.

Inclusion Criteria:

- Patients must have radiographic findings consistent with either:

- Recurrent high-grade glioma, or

- Metastatic disease to the brain that has progressed after treatment with whole
brain radiation therapy or stereotactic radiosurgery; patients who have a
resectable brain metastasis as the only site of disease (i.e., no evidence of
systemic disease), are not eligible to participate

- Patients who are in need of a surgical debulking or a stereotactic biopsy for the
purpose of diagnosis or differentiating between tumor progression versus
treatment-induced effects following radiation therapy +/- chemotherapy will be
eligible to participate in the microdialysis part of the study prior to beginning
cycle 1 of bafetinib if the study neurosurgeon thinks there is a likelihood of being
able to place the microdialysis catheter into residual tumor (enhancing brain tissue)

- Patients who choose not to participate in the microdialysis part of the study may
enroll in the study and start treatment at cycle 1 of bafetinib

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control or abstinence) prior to study entry and
for 3 months following duration of study participation; should a woman become
pregnant or suspect that she is pregnant while participating on the trial, she should
inform her treating physician immediately

- Patients must have a Karnofsky Performance Status (KPS) >= 60%

- If corticosteroids are required for controlling cerebral edema, patients must be on a
stable dose for at least 1 week prior to enrollment

- Patients must not be taking any hepatic enzyme-inducing anticonvulsants (phenytoin,
carbamazepine, phenobarbital, primidone, oxcarbazepine) for at least 2 weeks prior to

- Absolute neutrophil count >= 1500 cells/mm^3

- Platelet count >= 100,000 cells/mm^3

- Total bilirubin =< 2.0 mg/dl

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =<
3 times the institutional upper limit of normal

- Alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 3
times the institutional upper limit of normal

- Serum creatinine =< 1.5 x the institutional upper limit of normal

- QTc interval < 480 msec on electrocardiogram (ECG)

- All subjects must have the ability to understand and the willingness to sign a
written informed consent

- Patients must have recovered from any toxicity of prior therapies (including brain
radiation); an interval of at least 6 weeks must have elapsed since the completion of
a nitrosourea-containing chemotherapy regimen; patients who have undergone a recent
craniotomy cannot begin bafetinib until at least 2 weeks after the surgery

Exclusion Criteria:

- Patients who are currently receiving chemotherapy or are enrolled in another
treatment clinical trial

- Patients with a coagulopathy or bleeding disorder

- Patients on anticoagulant drug therapy or medications that inhibit platelet function,
such as ibuprofen or other non-steroidal anti-inflammatory drugs

- Clinically evident congestive heart failure > class II of the New York Heart
Association (NYHA) guidelines

- Clinically significant cardiac arrhythmias

- Patients taking a drug that can prolong the QT interval; if a potential study patient
is taking one of the prohibited drugs but s/he can safely stop it, then a washout
period of >= 7 days is required prior to starting bafetinib

- History or signs of active coronary artery disease with or without angina pectoris

- Patients who have a serious medical or psychiatric illness that could, in the
investigator's opinion, potentially interfere with the completion of treatment
according to this protocol or may not be able to comply with the safety monitoring
requirements of the study

- Human immunodeficiency virus (HIV)-positive patients receiving anti-retroviral
therapy are excluded from the study due to the possibility of pharmacokinetic (PK)
interactions with bafetinib; however, patients will not be routinely screened for HIV

- Female patients who are pregnant or breast-feeding

- Active, clinically significant serious infection requiring treatment with
antibiotics, anti-virals or anti-fungals

- Patients who have not recovered from the toxicities of prior chemotherapy or

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Area-under-the-concentration-time-curve (AUC) of bafetinib in dialysate

Outcome Time Frame:

every hour for 24 hours after first dose of bafetinib

Safety Issue:


Principal Investigator

Jana Portnow

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center


United States: Federal Government

Study ID:




Start Date:

December 2010

Completion Date:

March 2013

Related Keywords:

  • Adult Anaplastic Astrocytoma
  • Adult Anaplastic Ependymoma
  • Adult Anaplastic Oligodendroglioma
  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Adult Mixed Glioma
  • Recurrent Adult Brain Tumor
  • Tumors Metastatic to Brain
  • Adult Anaplastic Oligoastrocytoma
  • Los Angeles
  • Astrocytoma
  • Brain Neoplasms
  • Ependymoma
  • Glioblastoma
  • Glioma
  • Oligodendroglioma
  • Gliosarcoma



City of Hope Medical CenterDuarte, California  91010
South Pasadena Cancer CenterSouth Pasadena, California  91030