Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma
A Phase I/II Trial of OSI-774 in Patients With Recurrent Malignant Gliomas and Malignant Gliomas Post Radiation Therapy
5 other identifiers
interventional
136
1 country
7
Brief Summary
Phase I/II trial to study the effectiveness of erlotinib in treating patients who have recurrent malignant glioma or recurrent or progressive meningioma. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2002
Longer than P75 for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 6, 2002
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
July 13, 2017
CompletedAugust 17, 2017
July 1, 2017
8.3 years
September 6, 2002
May 4, 2017
July 14, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
Number of Dose Limiting Toxicity (DLT) Each Dose Level Phase I
DLT Definition: any grade 3 thrombocytopenia and grade 4 anemia and neutropenia; any non-hematologic grade 3 toxicity; failure to recover from toxicities to be eligible for re-treatment with erlotinib within 2 weeks of the last dose of erlotinib.
28 days
Define Maximum Tolerated Dose (MTD) of Erlotinib by Phase 1 Cohorts
standard 3+3 dose escalation design 3 patients in each dose level, observed for 28 days before enrollment to next level. if none of the patients experienced DLT dose escalated, if 1 of 3 experienced DLT 3 more enrolled at that level, if none of the 3 additional pts had DLT escalate to next level, if one or more of the additional pts experienced DLT, the MTD was exceeded and 3 more patients were treated at the next lower dose (if only 3 pts treated at the lower dose). The MTD is the dose at which 0/3 or 1/6 patients have experienced a DLT with the next higher dose having at least 2/3 or 2/6 patients encountering DLT.
cycle 1 - 28 days
6 Months Progression-free Survival in Recurrent Malignant Gliomas (Phase II)
Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
6 months
Secondary Outcomes (15)
Percent of Participants With a Grade 3 or 4 Adverse Events Phase 1
1 year
1 Year Survival - Phase II Newly Diagnosed GBM Post RT
At 1 year
Overall Survival Newly Diagnosed GBM Post RT
2 years
Response Rate (Complete or Partial Response) Graded Using Modified RECIST Criteria Phase II
At 1 year
Percent of Patients With One or More Grade 3-5 Toxicity Described Based on the CTC Severity Grading Phase II
Up to 1 year
- +10 more secondary outcomes
Study Arms (2)
Phase 1 Dose Escalation
EXPERIMENTALPhase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. erlotinib hydrochloride given orally Other: pharmacological study.
Phase 2 recurrent malignant gliomas and nonprogressive GBM
EXPERIMENTALPhase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose (150mg/day. patients requiring surgery treated 7 days prior to tumor removal (150mg/day) PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR) erlotinib hydrochloride given orally Other: pharmacological study, laboratory biomarker analysis.
Interventions
given orally
correlative studies
correlative studies
Eligibility Criteria
You may qualify if:
- One of the following diagnoses:
- Histologically confirmed intracranial malignant glioma
- Glioblastoma multiforme (GBM), anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, or malignant astrocytoma not otherwise specified
- Original histology of low-grade glioma allowed provided a subsequent histology of malignant glioma is confirmed
- Histologically or radiographically confirmed recurrent or progressive benign or malignant meningioma
- Progressive disease or tumor recurrence on MRI or CT scan
- Phase I: No more than 3 prior relapses and no more than 2 prior chemotherapy\* or biologic therapy regimens
- Phase II: No more than 2 prior relapses and no more than 2 prior chemotherapy\* or biologic therapy regimens
- Patients with progressive disease must have failed prior radiotherapy\* that was completed at least 4 weeks ago
- Patients with progressive disease between 4 and 12 weeks after completion of external beam radiotherapy must have clear evidence of progression on MRI
- Patients with GBM who have completed external beam radiotherapy and do not show progression are eligible
- Patients with progressive disease after interstitial brachytherapy or stereotactic radiosurgery must have confirmed true progression rather than radiation necrosis based upon positron-emission tomography, thallium scanning, MRI, or surgical documentation
- Measurable or evaluable disease
- Performance status - Karnofsky 60-100%
- More than 8 weeks
- +41 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
University of California Los Angeles
Los Angeles, California, 90095, United States
University of California San Francisco
San Francisco, California, 94115, United States
National Cancer Institute Neuro-Oncology Branch
Bethesda, Maryland, 20814, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75235, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Related Publications (1)
Raizer JJ, Abrey LE, Lassman AB, Chang SM, Lamborn KR, Kuhn JG, Yung WK, Gilbert MR, Aldape KD, Wen PY, Fine HA, Mehta M, Deangelis LM, Lieberman F, Cloughesy TF, Robins HI, Dancey J, Prados MD; North American Brain Tumor Consortium. A phase I trial of erlotinib in patients with nonprogressive glioblastoma multiforme postradiation therapy, and recurrent malignant gliomas and meningiomas. Neuro Oncol. 2010 Jan;12(1):87-94. doi: 10.1093/neuonc/nop017. Epub 2009 Dec 14.
PMID: 20150371BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lauren E Abrey, MD
- Organization
- Adult Brain Tumor Consortium
Study Officials
- PRINCIPAL INVESTIGATOR
Lauren Abrey, MD
National Cancer Institute (NCI)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2002
First Posted
January 27, 2003
Study Start
August 1, 2002
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
August 17, 2017
Results First Posted
July 13, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share