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A phase I/II trial of vandetanib for patients with recurrent malignant glioma.

Al's Comment:

 This article reports the results of clinical trial of the drug Vandetanib (Caprelsa).  This drug is FDA approved for thyroid cancer and readily avaialble.  It is not approved for brain tumors.

On brain tumors, it did not show good results when used alone.  My thoughts are that this type of treatment needs to either be individualized - used only when you know the patient's tumor overexpressed the targets, or as part of a cocktail where it is combined with other treatments to block multiple pathways at once so the tumor can not evade it.

Posted on: 11/13/2012

Neuro Oncol. 2012 Oct 25. [Epub ahead of print]

A phase I/II trial of vandetanib for patients with recurrent malignant glioma.

Kreisl TN, McNeill KA, Sul J, Iwamoto FM, Shih J, Fine HA.
Neuro-Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland (T.K., K.M., F.I., J.S., H.F.); Biometric Research Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland (J.S.).

Vandetanib is a once-daily multitargeted tyrosine kinase inhibitor of vascular endothelial growth factor receptor-2, epidermal growth factor receptor, and the rearranged-during-transfection oncogene. A phase I trial was conducted to describe the pharmacokinetics of vandetanib in patients with recurrent glioma on enzyme-inducing anti-epileptic drugs (EIAEDs) and to identify the maximum tolerated dose (MTD) in this population. A phase II trial evaluated the efficacy of vandetanib in patients with recurrent malignant glioma not on EIAEDs as measured by 6-month progression-free survival (PFS6). In the phase I trial, 15 patients were treated with vandetanib at doses of 300, 400, and 500 mg/day, in a standard dose-escalation design. The MTD in patients on EIAEDs was 400 mg/day, and steady-state levels were similar to those measured in patients not on EIAEDs. Dose-limiting toxicities were prolonged QTc and thromboembolism. Thirty-two patients with recurrent glioblastoma multiforme (GBM) and 32 patients with recurrent anaplastic gliomas (AGs) were treated in the phase II trial, at a dosage of 300 mg/day on 28-day cycles. Six patients (4 GBM, 2 AG) had radiographic response. PFS6 was 6.5% in the GBM arm and 7.0% in the AG arm. Median overall survival was 6.3 months in the GBM arm and 7.6 months in the AG arm. Seizures were an unexpected toxicity of therapy. Vandetanib did not have significant activity in unselected patients with recurrent malignant glioma.

PMID: 23099652 [PubMed - as supplied by publisher]


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