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Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma

Primary Purpose

Adult Anaplastic Astrocytoma, Adult Anaplastic Oligodendroglioma, Adult Giant Cell Glioblastoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
erlotinib hydrochloride
laboratory biomarker analysis
pharmacological study
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Anaplastic Astrocytoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 mg/dL (transfusion allowed) Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT less than 1.5 times ULN Creatinine less than 1.5 mg/dL None of the following ophthalmic abnormalities: Abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome) Congenital abnormality (e.g., Fuch's dystrophy) Abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose) Abnormal corneal sensitivity test (Schirmer test or similar tear production test) Patients found to have dry eyes on examination but have an otherwise normal examination allowed No active infection No other serious concurrent medical illness No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No other disease that would obscure toxicity or dangerously alter drug metabolism No significant medical illness that would preclude study participation Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for 12 weeks after study participation See Disease Characteristics At least 1 week since prior thalidomide At least 1 week since prior interferon At least 4 weeks since prior SU5416 or other experimental biologic agents See Disease Characteristics No prior chemotherapy (including polifeprosan 20 with carmustine implant [Gliadel wafers]) for patients with stable GBM At least 2 weeks since prior vincristine At least 3 weeks since prior procarbazine At least 6 weeks since prior nitrosoureas At least 1 week since prior tamoxifen See Disease Characteristics Recovered from prior radiotherapy No more than 6 weeks since prior external beam radiotherapy for patients with GBM without evidence of progression Recovered from prior surgery Recovered from prior therapy At least 1 week since prior noncytotoxic agents (e.g., isotretinoin) except radiosensitizers At least 4 weeks since prior cytotoxic therapy At least 4 weeks since prior tipifarnib or imatinib mesylate No prior erlotinib or other epidermal growth factor receptor inhibitors No concurrent combination antiretroviral therapy for HIV-positive patients

Sites / Locations

  • University of California Los Angeles
  • University of California San Francisco
  • National Cancer Institute Neuro-Oncology Branch
  • Memorial Sloan Kettering Cancer Center
  • University of Pittsburgh
  • University of Texas Southwestern Medical Center
  • University of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Phase 1 Dose Escalation

Phase 2 recurrent malignant gliomas and nonprogressive GBM

Arm Description

Phase 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 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.

Outcomes

Primary Outcome Measures

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.
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.
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).

Secondary Outcome Measures

Percent of Participants With a Grade 3 or 4 Adverse Events Phase 1
CTCAE
1 Year Survival - Phase II Newly Diagnosed GBM Post RT
12 month survival for newly diagnosed stable GBM post RT treated with erlotinib post RT
Overall Survival Newly Diagnosed GBM Post RT
Overall Survival defined as Time from Start of treatment to time of death due to any cause
Response Rate (Complete or Partial Response) Graded Using Modified RECIST Criteria Phase II
Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined. Complete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids. Partial Response (PR): >/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone. Stable/No Response: Does not qualify for CR, PR, or progression. 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).
Percent of Patients With One or More Grade 3-5 Toxicity Described Based on the CTC Severity Grading Phase II
Summarized by descriptive statistics.
Time of Peak Plasma Concentration Per Dose Level Phase I (on Anticonvulsants) -
plasma concentrations relative to erlotiniab administration and sample time and dose level
Peak Plasma Concentration Per Dose Level Phase I (on Anticonvulsants) -
plasma concentrations relative to erlotiniab administration and sample time and dose level
Estimation of the Area Under the Curve Per Dose Level Phase I (on Anticonvulsants) -
plasma concentrations relative to erlotiniab administration and sample time and dose level
Trough Level Per Dose Level Phase I (on Anticonvulsants) -
plasma concentrations relative to erlotiniab administration and sample time and dose level
Peak Plasma Concentration Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg -
plasma concentrations relative to erlotiniab administration and sample time and dose level
Time to Peak Plasma Concentration for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg -
plasma concentrations relative to erlotiniab administration and sample time and dose level
Estimation of Area Under the Curve for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg-
plasma concentrations relative to erlotiniab administration and sample time and dose level
Trough Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg -
plasma concentrations relative to erlotiniab administration and sample time and dose level
Pharmacokinetics (Plasma) Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs
Drug administered 6 days prior to surgery
Pharmacokinetics (Tissue) Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs
Drug administered 6 days prior to surgery

Full Information

First Posted
September 6, 2002
Last Updated
July 14, 2017
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00045110
Brief Title
Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma
Official Title
A Phase I/II Trial of OSI-774 in Patients With Recurrent Malignant Gliomas and Malignant Gliomas Post Radiation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
OBJECTIVES: Phase 1 I. Determine the maximum tolerated dose of erlotinib in patients with recurrent malignant glioma or recurrent or progressive meningioma. II. Determine the safety profile of this drug in these patients. III. Determine the pharmacokinetics of this drug in these patients. Phase 2 I. Determine the 6-month progression-free survival (recurrent malignant glioma) II.12-month survival of patients treated with this drug (stable glioblastoma post radiation therapy) Phase 2 - Secondary Recurrent Malignant Glioma I. Objective Tumor Response rate associated with erlotinib therapy in recurrent or progressive malignant glioma. III. 12-month survival of patients treated with this drug Determine the safety profile of this drug in these patients. IV.. Determine the pharmacokinetics of this drug in these patients OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to study phase (I vs II), concurrent enzyme-inducing antiepileptic drugs (EIAEDs) (yes vs no), histology (recurrent GBM vs recurrent anaplastic glioma vs recurrent meningioma vs stable GBM), preoperative candidacy (yes vs no), and concurrent steroids (yes vs no). Phase 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. Phase II: Once the MTD is determined, additional patients concurrently receiving EIAEDs are treated with erlotinib as above at the phase II dose. Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose. Patients are followed for survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Anaplastic Astrocytoma, Adult Anaplastic Oligodendroglioma, Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Adult Grade I Meningioma, Adult Grade II Meningioma, Adult Grade III Meningioma, Recurrent Adult Brain Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1 Dose Escalation
Arm Type
Experimental
Arm Description
Phase 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.
Arm Title
Phase 2 recurrent malignant gliomas and nonprogressive GBM
Arm Type
Experimental
Arm Description
Phase 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.
Intervention Type
Drug
Intervention Name(s)
erlotinib hydrochloride
Other Intervention Name(s)
CP-358,774, erlotinib, OSI-774
Intervention Description
given orally
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
correlative studies
Intervention Type
Other
Intervention Name(s)
pharmacological study
Intervention Description
correlative studies
Primary Outcome Measure Information:
Title
Number of Dose Limiting Toxicity (DLT) Each Dose Level Phase I
Description
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.
Time Frame
28 days
Title
Define Maximum Tolerated Dose (MTD) of Erlotinib by Phase 1 Cohorts
Description
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.
Time Frame
cycle 1 - 28 days
Title
6 Months Progression-free Survival in Recurrent Malignant Gliomas (Phase II)
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percent of Participants With a Grade 3 or 4 Adverse Events Phase 1
Description
CTCAE
Time Frame
1 year
Title
1 Year Survival - Phase II Newly Diagnosed GBM Post RT
Description
12 month survival for newly diagnosed stable GBM post RT treated with erlotinib post RT
Time Frame
At 1 year
Title
Overall Survival Newly Diagnosed GBM Post RT
Description
Overall Survival defined as Time from Start of treatment to time of death due to any cause
Time Frame
2 years
Title
Response Rate (Complete or Partial Response) Graded Using Modified RECIST Criteria Phase II
Description
Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined. Complete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids. Partial Response (PR): >/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone. Stable/No Response: Does not qualify for CR, PR, or progression. 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).
Time Frame
At 1 year
Title
Percent of Patients With One or More Grade 3-5 Toxicity Described Based on the CTC Severity Grading Phase II
Description
Summarized by descriptive statistics.
Time Frame
Up to 1 year
Title
Time of Peak Plasma Concentration Per Dose Level Phase I (on Anticonvulsants) -
Description
plasma concentrations relative to erlotiniab administration and sample time and dose level
Time Frame
baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1.
Title
Peak Plasma Concentration Per Dose Level Phase I (on Anticonvulsants) -
Description
plasma concentrations relative to erlotiniab administration and sample time and dose level
Time Frame
baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5
Title
Estimation of the Area Under the Curve Per Dose Level Phase I (on Anticonvulsants) -
Description
plasma concentrations relative to erlotiniab administration and sample time and dose level
Time Frame
baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5
Title
Trough Level Per Dose Level Phase I (on Anticonvulsants) -
Description
plasma concentrations relative to erlotiniab administration and sample time and dose level
Time Frame
cycle 1 day eight
Title
Peak Plasma Concentration Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg -
Description
plasma concentrations relative to erlotiniab administration and sample time and dose level
Time Frame
baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5
Title
Time to Peak Plasma Concentration for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg -
Description
plasma concentrations relative to erlotiniab administration and sample time and dose level
Time Frame
baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5
Title
Estimation of Area Under the Curve for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg-
Description
plasma concentrations relative to erlotiniab administration and sample time and dose level
Time Frame
baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5
Title
Trough Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg -
Description
plasma concentrations relative to erlotiniab administration and sample time and dose level
Time Frame
One sample on day 8 cycle 1
Title
Pharmacokinetics (Plasma) Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs
Description
Drug administered 6 days prior to surgery
Time Frame
Pre-surgery and time of resection
Title
Pharmacokinetics (Tissue) Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs
Description
Drug administered 6 days prior to surgery
Time Frame
Pre-surgery and time of resection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 mg/dL (transfusion allowed) Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT less than 1.5 times ULN Creatinine less than 1.5 mg/dL None of the following ophthalmic abnormalities: Abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome) Congenital abnormality (e.g., Fuch's dystrophy) Abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose) Abnormal corneal sensitivity test (Schirmer test or similar tear production test) Patients found to have dry eyes on examination but have an otherwise normal examination allowed No active infection No other serious concurrent medical illness No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No other disease that would obscure toxicity or dangerously alter drug metabolism No significant medical illness that would preclude study participation Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for 12 weeks after study participation See Disease Characteristics At least 1 week since prior thalidomide At least 1 week since prior interferon At least 4 weeks since prior SU5416 or other experimental biologic agents See Disease Characteristics No prior chemotherapy (including polifeprosan 20 with carmustine implant [Gliadel wafers]) for patients with stable GBM At least 2 weeks since prior vincristine At least 3 weeks since prior procarbazine At least 6 weeks since prior nitrosoureas At least 1 week since prior tamoxifen See Disease Characteristics Recovered from prior radiotherapy No more than 6 weeks since prior external beam radiotherapy for patients with GBM without evidence of progression Recovered from prior surgery Recovered from prior therapy At least 1 week since prior noncytotoxic agents (e.g., isotretinoin) except radiosensitizers At least 4 weeks since prior cytotoxic therapy At least 4 weeks since prior tipifarnib or imatinib mesylate No prior erlotinib or other epidermal growth factor receptor inhibitors No concurrent combination antiretroviral therapy for HIV-positive patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Abrey, MD
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
National Cancer Institute Neuro-Oncology Branch
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20150371
Citation
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.
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Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma

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