Status:
COMPLETED
EGFR Inhibition Using Weekly Erlotinib for Recurrent Malignant Gliomas
Lead Sponsor:
Andrew B Lassman, MD
Collaborating Sponsors:
Genentech, Inc.
OSI Pharmaceuticals
Conditions:
Brain Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 we...
Detailed Description
This is a pilot study of erlotinib for subjects who have a brain tumor called a glioblastoma or another malignant glioma, which has continued to grow after treatment. The purpose of this study is to t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 7 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01257594
Start Date
January 7 2011
End Date
December 31 2018
Last Update
May 25 2023
Active Locations (4)
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1
Memorial Sloan-Kettering at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan-Kettering Cancer Center at Commack
Commack, New York, United States, 11725
3
Columbia University Irving Medical Center
New York, New York, United States, 10032
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065