EGFR Inhibition Using Weekly Erlotinib for Recurrent Malignant Gliomas

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Andrew B Lassman, MD
Study ID
NCT01257594
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • erlotinib — DRUG
    For patients with no cytoreductive surgery planned, patients will receive single-agent erlotinib at a starting dose of 2000 mg on days 1 of every 7 days. For patients with cytoreductive surgery planned, patients will receive single-agent erlotinib at a starting dose of 2000 mg day 1 of every 7 days (+/- 2 days). One pre-operative dose of 2000 mg erlotinib will be administered in an open-label, unblinded manner, administered in the hospital "on call" to the operating room.
  • Cytoreductive Surgery — PROCEDURE
    Standard procedure

Study Details

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 Dates

First listed
Dec 9, 2010
Start date
Jan 7, 2011
Status verified
May 2023
Primary completion
Nov 22, 2016
Completion
Dec 31, 2018

Study Design

Enrollment
22 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: No cytoreductive surgery planned
    Patients who are not candidates for surgery as part of their routine care will enroll into the medical arm of the trial. They will initiate pulsatile erlotinib dosing and continue therapy until either disease progression or intolerable toxicity.
  • Experimental: Cytoreductive surgery planned
    Patients scheduled for "salvage" resection as part of their routine care will be considered for this cohort. They will receive 1 pre-operative dose of 2000 mg erlotinib. Resection will occur ≤ 3 hours after the pre-operative dose. After recovery from surgery, patients will resume pulsatile erlotinib dosing.

Primary Outcome Measure

Clinical Benefit Rate (either radiographic response or at least 6 months of progression-free survival) [ Time Frame: Up to 3 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
Memorial Sloan-Kettering at Basking RidgeBasking RidgeNew Jersey07920-
Memorial Sloan-Kettering Cancer Center at CommackCommackNew York11725-
Columbia University Irving Medical CenterNew YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-

Find similar trials in Basking Ridge, NJ

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Memorial Sloan-Kettering at Basking Ridge· Basking Ridge, NJMemorial Sloan-Kettering Cancer Center at Commack· Commack, NYColumbia University Irving Medical Center· New York, NYMemorial Sloan Kettering Cancer Center· New York, NY

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