EGFR Inhibition Using Weekly Erlotinib for Recurrent Malignant Gliomas

Completed · Phase 1

Conditions studied: Brain Cancer

In brief

The purpose of this study is to test the effectiveness of a drug called erlotinib in treating the tumor. This is a multi-center pilot study that explores efficacy and molecular effects of high dose weekly erlotinib for recurrent EGFR vIII mutant malignant gliomas, and correlate molecular profile of pre-treatment tissue with outcome.

Key facts

Study ID

NCT01257594

Run by

Andrew B Lassman, MD

People needed

22

Starts

2011-01-07

Expected to finish

2018-12-31

Last updated by the study team

2023-05-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed intracranial malignant glioma of the following types: Glioblastoma (GBM), Gliosarcoma (GS), Anaplastic astrocytoma (AA), Anaplastic oligodendroglioma (AO), Anaplastic oligoastrocytoma (AOA, also called anaplastic mixed gliomas or AMG), High grade glioma not otherwise specified (NOS).
• EGFRvIII mutation detected on pretreatment tissue from at least 1 prior surgery.
• At least 15 unstained slides or at least 1 tissue blocks must be collected from at least one prior surgery.
• Recovered from toxic effects of prior therapies.
• Able to undergo contrast enhanced MRI scans (or CT scans for patients unable to tolerate MRI).
• Shown unequivocal evidence for contrast enhancing tumor progression by MRI (or CT for patients who cannot tolerate MRI) in comparison to a prior scan.
• Age > or = 18 years.
• Karnofsky Performance Status > or = 60%.
• Life expectancy of > 8 weeks.
• Normal organ and marrow function, adequate liver function and adequate renal function before starting therapy.
• Women of child-bearing potential and men must agree to use adequate contraception.
• Women of childbearing potential must have a negative pregnancy test documented within 7 days prior to treatment.
• Women must agree not to breast feed.
• Ability to understand and the willingness to sign a written informed consent document.
• Ability to swallow the tablets.
• Cohort A (medical) specific inclusion criteria:
• Fulfill all of the general inclusion criteria.
• MRI/CT must demonstrate measurable enhancing tumor of at least 1cm2 in cross-sectional area to allow assessment of radiographic response, unless: measurable disease is not present because the patient underwent gross total resection as the most recent anti-tumor therapy.
• At least 3 months have elapsed between any prior brain radiotherapy and initiation of study therapy.
• MRI/CT must demonstrate measureable enhancing tumor at least 1cm by 1cm squared in cross-sectional area to allow assessment of radiographic response.
• Stable or decreasing dose of corticosteroids for a minimum of 5 days before the baseline MRI/CT.
• The baseline MRI/CT must be performed on the 14th day or less prior to initiation of study treatment.
• Cohort B (surgical) specific inclusion criteria:
• Fulfill all of the general inclusion criteria.
• An MRI/CT scan showing progression is required.

You may not qualify if…

• Received prior treatment with convection enhanced delivery, other catheter based intratumoral treatment, or carmustine (BCNU)/Gliadel wafers.
• Prior therapy that included stereotactic radiosurgery during therapy for newly diagnosed or recurrent disease, or re-irradiation of any type, must have confirmation of true progressive disease rather than radiation necrosis based upon surgical documentation of recurrent/progressive disease.
• Prior treatment with an EGFR inhibitor.
• Received prior treatment with direct Vascular endothelial growth factor (VEGF)/Vascular Endothelial Growth Factor Receptors (VEGFR) inhibitors.
• Smoking or plan to smoke tobacco or marijuana during study therapy.
• Receiving any other investigational agents concurrently with study treatment.
• Taking Enzyme Inducing Anti-Epileptic Drug (EIAED). If previously on an EIAED, the patient must be off of it for at least two weeks prior to study treatment.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib.
• Uncontrolled intercurrent illness that would limit compliance with study requirements.
• Have HIV and are receiving combination antiretroviral therapy.
• Other active concurrent malignancy.

Where it is running

• Memorial Sloan-Kettering at Basking Ridge — Basking Ridge, New Jersey, United States
• Memorial Sloan-Kettering Cancer Center at Commack — Commack, New York, United States
• Columbia University Irving Medical Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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