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Per design: Stop if fewer than 3 cohorts by molecular classification were with 10 participants or only 1 cohort enrolled at least 15 participants of 50.
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| Name | Class |
|---|---|
| Boston Children's Hospital | OTHER |
| University of California, San Francisco | OTHER |
| Ann & Robert H Lurie Children's Hospital of Chicago | OTHER |
| Children's Healthcare of Atlanta |
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Diagnosis of diffuse intrinsic pontine glioma (DIPG) for decades has relied on imaging studies and clinical findings. Histologic confirmation has been absent with surgical biopsy of brainstem tumors not believed to have acceptable safety. The prognosis of DIPG has remained quite poor and novel therapeutic strategies are needed. This DIPG Biology and Treatment Study (DIPG-BATS) study incorporates a surgical biopsy at presentation using strict preoperative neurosurgical planning and stratifies participants to receive FDA-approved agents chosen on the basis of specific biologic targets. This is the first prospective national clinical trial to examine the feasibility and safety of incorporating surgical biopsy into potential treatment strategies for children with DIPG.
The primary objective of this study is to estimate the overall survival of children and young adults with DIPG in the context of a molecularly based treatment strategy, compared to historical controls (COG ACNS0126). Secondary objectives were to determine the safety and potential morbidity associated with biopsy of classic DIPGs based on imaging and clinical history as well as ability to perform biologic analyses on the biopsy material obtained to guide therapy. At study entry, a MRI-guided frameless or frame-based stereotactic biopsy will be performed approaching the pontine termentum through a trans-cerebellar or trans-frontal route. The exact biopsy location will be determined by the treating neurosurgeon at the designated participating site with the goal of minimizing procedural risk. Treatment directed based on tumor biopsy results requires classification of patients into 1 of 4 potential cohorts: O^6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status (negative versus positive) and epidermal growth factor receptor (EGFR) overexpression status (negative versus positive).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| radiation + bevacizumab | Experimental | Cohort 1: MGMT-/EGFR- Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles |
|
| radiation + bevacizumab + erlotinib | Experimental | Cohort 2: MGMT-/EGFR+ Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles Erlotinib: Administered orally at 85 mg/m2 daily continuously during radiation therapy, through the interim period and for up to 10 maintenance cycles |
|
| radiation + bevacizumab + temozolomide | Experimental | Cohort 3. MGMT+/EGFR- Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles Temozolomide: Administered orally at 90 mg/m2/day continuously during radiation therapy, held through the interim period and then 200 mg/m2/day for 5 days for up to 10 maintenance cycles |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 9-month Overall Survival (OS) Rate | 9-month overall survival is the percentage of participants remaining alive 9 months from registration. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Lethal Complications From Surgery | The rate of lethal complications from surgery is the percentage of participants dying as a result of surgery. | 2 weeks |
| Grade 3-4 Post-Procedural Surgery-Related Toxicity Rate |
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Inclusion Criteria:
Participants must meet the following criteria on screening examination to be eligible to participate in the study:
Tumor: Newly diagnosed non-disseminated diffuse intrinsic pontine glioma based on classic clinical AND radiographic finding.
No prior radiation therapy or chemotherapy.
Age: Patient must be 3 to < 18 years of age at the time of diagnosis.
Performance Score: Karnofsky Performance Scale > 12 y/o >/= 50 or Lansky Performance Score for patients < 12y/o 50 assessed within two-weeks prior to enrollment.
Participants must have normal organ and marrow function as defined below within two week s prior to enrollment:
Female patients of childbearing potential must have negative serum or urine pregnancy test. Patient must not be pregnant or breast feeding.
Patients of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy.
Patients receiving any other anticancer or experimental drug therapy.
Patients with disseminated intrinsic diffuse brainstem gliomas in either brain or spine (can be based on clinical evaluation).
Participants receiving any medications or substances that are strong/intermediate inhibitors or inducers of Cytochrome P450 (CYP450), Cytochrome P3A4(CYP3A4) or Cytochrome 1A2 (CYP1A2) are ineligible. Lists including medications and substances known or with the potential to interact with the CYP450 CYP3A4 or CYP1A2 isoenzymes are provided in Appendix I.
Use of hematopoietic growth factors within the 2 weeks prior to initiation of therapy.
Patients with evidence of spontaneous hemorrhage greater than 0.5cm unrelated to surgery.
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women are excluded from this study because bevacizumab, temozolomide and erlotinib can have potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued.
-
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| Name | Affiliation | Role |
|---|---|---|
| Karen D. Wright, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | United States | ||
| Children's Hospital Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29741745 | Result | Gupta N, Goumnerova LC, Manley P, Chi SN, Neuberg D, Puligandla M, Fangusaro J, Goldman S, Tomita T, Alden T, DiPatri A, Rubin JB, Gauvain K, Limbrick D, Leonard J, Geyer JR, Leary S, Browd S, Wang Z, Sood S, Bendel A, Nagib M, Gardner S, Karajannis MA, Harter D, Ayyanar K, Gump W, Bowers DC, Weprin B, MacDonald TJ, Aguilera D, Brahma B, Robison NJ, Kiehna E, Krieger M, Sandler E, Aldana P, Khatib Z, Ragheb J, Bhatia S, Mueller S, Banerjee A, Bredlau AL, Gururangan S, Fuchs H, Cohen KJ, Jallo G, Dorris K, Handler M, Comito M, Dias M, Nazemi K, Baird L, Murray J, Lindeman N, Hornick JL, Malkin H, Sinai C, Greenspan L, Wright KD, Prados M, Bandopadhayay P, Ligon KL, Kieran MW. Prospective feasibility and safety assessment of surgical biopsy for patients with newly diagnosed diffuse intrinsic pontine glioma. Neuro Oncol. 2018 Oct 9;20(11):1547-1555. doi: 10.1093/neuonc/noy070. |
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Study screening procedures were conducted at 23 sites in the United States. Eligible participants enrolled between September 2011 and September 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: MGMT-/EGFR- | Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| OTHER |
| Children's Hospital Colorado | OTHER |
| Children's Hospital Los Angeles | OTHER |
| Children's Hospital of Michigan | OTHER |
| Children's Hospitals and Clinics of Minnesota | OTHER |
| Cook Children's Medical Center | OTHER |
| OHSU Doernbecher Children's Hospital | OTHER |
| Duke University | OTHER |
| Johns Hopkins University | OTHER |
| Nicklaus Children's Hospital f/k/a Miami Children's Hospital | OTHER |
| Nemours Children's Clinic | OTHER |
| New York University | OTHER |
| Milton S. Hershey Medical Center | OTHER |
| Seattle Children's Hospital | OTHER |
| Lucile Packard Children's Hospital | OTHER |
| University of Louisville | OTHER |
| Children's National Research Institute | OTHER |
| Washington University School of Medicine | OTHER |
| Phoenix Children's Hospital | OTHER |
| Medical University of South Carolina | OTHER |
This is not a randomized trial rather participants are classified and therapy is directed based on molecular profile obtained from surgical biopsy.
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|
| radiation + bevacizumab + erlotinib + temozolomide | Experimental | Cohort 4. MGMT+/EGFR+ Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles Erlotinib: Administered orally at 85 mg/m2 daily continuously during radiation therapy, through the interim period and for up to 10 maintenance cycles |
|
| Erlotinib | Drug |
|
|
| Temozolomide | Drug |
|
|
| Radiation | Radiation |
|
|
Grade 3-4 post-procedural surgery-related toxicity rate is the percentage of participants experiencing at least one grade 3-4 adverse event (AE) during the post-procedural time frame of 14 days attributable to the surgical procedure based on NCI Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4).
| 2 weeks |
| Delay in Radiation Therapy Start | The number of participants delaying the start of radiation therapy by more than 3 weeks due to complications as a result of surgical biopsy to obtain diagnostic tumor sample. | 3 weeks |
| Feasibility Rate of Molecular Approach to Therapy | Feasibility rate of the molecular strategy is based on the percentage of participants either with inadequate tissue from surgical biopsy to confirm DIPG diagnosis and/or with uninterpretable results for identification of EGFR overexpression and MGMT methylation status. | 3 weeks |
| Number of Participants With Grade 3-4 Treatment-Related Toxicity Over Chemoradiation Therapy | Counts any participant experiencing at least one treatment-related grade 3 or 4 adverse event (AE) with treatment attribution of possibly, probably or definite based on NCI Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4) over chemoradiation therapy as reported on case report forms. | Adverse events were routinely throughout treatment. Treatment duration was a median of 6.4 months (range 0.4-13.4 months) in this study cohort. |
| Median Progression Free Survival (PFS) | PFS based on the Kaplan-Meier method is defined as the duration of time [months (m)] from study entry to documented disease progression (PD) or death. Participants alive without PD are censored at the date of last disease assessment. For intrinsic pontine brainstem gliomas, only one lesion/mass is present at diagnosis. Comparisons of maximal 2-dimensional measurements, TxW (product of the longest diameter [width (W)] and its longest perpendicular diameter [transverse (T)]) are used to assess response for this target lesion. PD is 25% or more increase, taking as reference the smallest product observed since the start of treatment, or the appearance of one or more new lesions. | Disease assessments using a standard CNS imaging protocol occurred chemoradiation cycles 1 and 2, every other maintenance cycle, every 3 months post-treatment year 1 then annually until PD or therapy change; In this study cohort, follow-up was up to 34m. |
| Los Angeles |
| California |
| 90027 |
| United States |
| Stanford University/Lucile Packard Children's Hospital | Palo Alto | California | 94304 | United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | United States |
| Miami Children's Hospital | Miami | Florida | 33155 | United States |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | United States |
| Ann & Robert H Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Johns Hopkins | Baltimore | Maryland | 21287 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | United States |
| Children's Hospitals and Clinics of Minnesota | Minneapolis | Minnesota | 55404 | United States |
| Washington University Medical Center | St Louis | Missouri | 63110 | United States |
| New York University | New York | New York | 10016 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Doernbecher Children's Hospital | Portland | Oregon | 97239 | United States |
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| FG001 | Cohort 2: MGMT-/EGFR+ | Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles |
| FG002 | Cohort 3 MGMT+/EGFR- | Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles Temozolomide: Administered orally at 90 mg/m2/day continuously during radiation therapy, held through the interim period and then 200 mg/m2/day for 5 days for up to 10 maintenance cycles |
| FG003 | Cohort 4. MGMT+/EGFR+ | Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles Erlotinib: Administered orally at 85 mg/m2 daily continuously during radiation therapy, through the interim period and for up to 10 maintenance cycles Temozolomide: Administered orally at 90 mg/m2/day continuously during radiation therapy, held through the interim period and then 200 mg/m2/day for 5 days for up to 10 maintenance cycles |
| FG004 | Ineligible for Direct Treatment Assignment | All enrolled participants were to receive surgical biopsy to guide treatment assignment based on molecular results.Participants without an evaluable sample were ineligible for direct treatment assignment. |
| Underwent Stereotactic Biopsy |
|
| Started Assigned Chemoradiation |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The analysis dataset is comprised of all enrolled participants who underwent stereotactic biopsy.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Biopsied Participants | Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Treatment directed based on tumor biopsy results requires classification of patients into 1 of 4 potential cohorts: O^6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status (negative versus positive) and epidermal growth factor receptor (EGFR) overexpression status (negative versus positive). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| Molecular Classification | Treatment directed based on tumor biopsy results requires classification of patients into 1 of 4 potential cohorts: O^6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status (negative versus positive) and epidermal growth factor receptor (EGFR) overexpression status (negative versus positive). | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 9-month Overall Survival (OS) Rate | 9-month overall survival is the percentage of participants remaining alive 9 months from registration. | The analysis population is comprised of the subset of participants who underwent biopsy, obtained a molecularly-based treatment assignment and started assigned chemoradiation therapy. | Posted | Number | 90% Confidence Interval | percentage of participants | 9 months |
|
|
| |||||||||||||||||||||||||
| Secondary | Rate of Lethal Complications From Surgery | The rate of lethal complications from surgery is the percentage of participants dying as a result of surgery. | Posted | Number | 90% Confidence Interval | percentage of participants | 2 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Grade 3-4 Post-Procedural Surgery-Related Toxicity Rate | Grade 3-4 post-procedural surgery-related toxicity rate is the percentage of participants experiencing at least one grade 3-4 adverse event (AE) during the post-procedural time frame of 14 days attributable to the surgical procedure based on NCI Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4). | The analysis dataset is comprised of all enrolled participants who underwent stereotactic biopsy. | Posted | Number | 90% Confidence Interval | percentage of participants | 2 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Delay in Radiation Therapy Start | The number of participants delaying the start of radiation therapy by more than 3 weeks due to complications as a result of surgical biopsy to obtain diagnostic tumor sample. | The analysis dataset is comprised of all enrolled participants who underwent stereotactic biopsy. | Posted | Count of Participants | Participants | 3 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Feasibility Rate of Molecular Approach to Therapy | Feasibility rate of the molecular strategy is based on the percentage of participants either with inadequate tissue from surgical biopsy to confirm DIPG diagnosis and/or with uninterpretable results for identification of EGFR overexpression and MGMT methylation status. | The analysis dataset is comprised of all enrolled participants who underwent stereotactic biopsy. | Posted | Number | 90% Confidence Interval | percentage of participants | 3 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Grade 3-4 Treatment-Related Toxicity Over Chemoradiation Therapy | Counts any participant experiencing at least one treatment-related grade 3 or 4 adverse event (AE) with treatment attribution of possibly, probably or definite based on NCI Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4) over chemoradiation therapy as reported on case report forms. | The analysis population is comprised of the subset of participants who underwent surgical biopsy, obtained a molecularly-based treatment assignment and started assigned chemoradiation therapy. | Posted | Count of Participants | Participants | Adverse events were routinely throughout treatment. Treatment duration was a median of 6.4 months (range 0.4-13.4 months) in this study cohort. |
| ||||||||||||||||||||||||||||
| Secondary | Median Progression Free Survival (PFS) | PFS based on the Kaplan-Meier method is defined as the duration of time [months (m)] from study entry to documented disease progression (PD) or death. Participants alive without PD are censored at the date of last disease assessment. For intrinsic pontine brainstem gliomas, only one lesion/mass is present at diagnosis. Comparisons of maximal 2-dimensional measurements, TxW (product of the longest diameter [width (W)] and its longest perpendicular diameter [transverse (T)]) are used to assess response for this target lesion. PD is 25% or more increase, taking as reference the smallest product observed since the start of treatment, or the appearance of one or more new lesions. | The analysis population is comprised of the subset of participants who underwent surgical biopsy, obtained a molecularly-based treatment assignment and started assigned chemoradiation therapy. The PFS was aggregated across cohorts per statistical analysis plan to evaluate the effect of the "molecular strategy". | Posted | Median | Full Range | months | Disease assessments using a standard CNS imaging protocol occurred chemoradiation cycles 1 and 2, every other maintenance cycle, every 3 months post-treatment year 1 then annually until PD or therapy change; In this study cohort, follow-up was up to 34m. |
| |||||||||||||||||||||||||||
| Post-Hoc | 9-month Overall Survival (OS) Rate by Molecular Cohort | 9-month OS rate is the percentage of participants alive at 9 months from registration. | The analysis population is comprised of the subset of participants who underwent surgical biopsy, obtained a molecularly-based treatment assignment and started assigned chemoradiation therapy. | Posted | Number | 90% Confidence Interval | percentage of participants | 9 months |
|
Adverse events were routinely throughout treatment. Treatment duration was a median of 6.4 months (range 0.4-13.4 months) in this study cohort.
Maximum grade toxicity by type was first calculated within each arm. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term. The analysis population is comprised of the subset of participants who underwent surgical biopsy.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 MGMT-/EGFR- | Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles | 29 | 30 | 8 | 30 | 30 | 30 |
| EG001 | Cohort 2 MGMT-/EGFR+ | Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles Erlotinib: Administered orally at 85 mg/m2 daily continuously during radiation therapy, through the interim period and for up to 10 maintenance cycles | 14 | 14 | 9 | 14 | 14 | 14 |
| EG002 | Cohort 3: MGMT+/EGFR- | Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles Temozolomide: Administered orally at 90 mg/m2/day continuously during radiation therapy, held through the interim period and then 200 mg/m2/day for 5 days for up to 10 maintenance cycles | 3 | 3 | 1 | 3 | 3 | 3 |
| EG003 | Cohort 4. MGMT+/EGFR+ | Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles Erlotinib: Administered orally at 85 mg/m2 daily continuously during radiation therapy, through the interim period and for up to 10 maintenance cycles Temozolomide: Administered orally at 90 mg/m2/day continuously during radiation therapy, held through the interim period and then 200 mg/m2/day for 5 days for up to 10 maintenance cycles | 2 | 3 | 2 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| CD4 lymphocytes decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysphasia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Muscle weakness left-sided | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Muscle weakness right-sided | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders-Other | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Spasticity | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abducens nerve disorder | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Alkalosis | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Apnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Bullous dermatitis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cardiac disorders - Other | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| CD4 lymphocytes decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Conjunctivitis infective | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Cushingoid | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Death NOS | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysesthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysphasia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Ear and labyrinth disorders - Other | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema face | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Encephalitis infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Esophageal obstruction | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| External ear inflammation | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| External ear pain | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Eye disorders - Other | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Eyelid function disorder | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Facial muscle weakness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Facial nerve disorder | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gait disturbance | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastrointestinal disorders - Other | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| General disorders and administration site conditions - Other | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Glossopharyngeal nerve disorder | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemoglobin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Hirsutism | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoglossal nerve disorder | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and infestations - Other | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Intracranial hemorrhage | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Investigations - Other | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Irritability | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| IVth nerve disorder | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Joint range of motion decreased cervical spine | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Malaise | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mediastinal infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Metabolism and nutrition disorders - Other | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Middle ear inflammation | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Movements involuntary | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucosal infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Muscle weakness left-sided | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Muscle weakness right-sided | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Muscle weakness upper limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neck edema | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nervous system disorders - Other | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nystagmus | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Oculomotor nerve disorder | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Optic nerve disorder | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Otitis media | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Paronychia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Penile pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Perineal pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Personality change | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Postoperative hemorrhage | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pyramidal tract syndrome | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Rectal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Renal and urinary disorders - Other | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Renal calculi | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rhinitis infective | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Salivary gland fistula | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin atrophy | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin induration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Skin ulceration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Spasticity | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Stomach pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Trigeminal nerve disorder | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary urgency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urine discoloration | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vagus nerve disorder | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Weight gain | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
The study was terminated early having met the pre-specified stopping rule which required 3 or more cohorts with at least 10 patients each or 2 cohorts with at least 15 patients each in the first 50 patients with informative biopsies.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Wright | Dana-Farber Cancer Institute | 617.632.6740 | KarenD_Wright@dfci.harvard.edu |
| ID | Term |
|---|---|
| D000080443 | Diffuse Intrinsic Pontine Glioma |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D020295 | Brain Stem Neoplasms |
| D015192 | Infratentorial Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000069347 | Erlotinib Hydrochloride |
| D000077204 | Temozolomide |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D055585 | Physical Phenomena |
Not provided
Not provided
| MGMT+/EGFR- |
|
| MGMT+/EGFR+ |
|
|
|
|
|
| OG002 | Cohort 3: MGMT+/EGFR- | Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles Temozolomide: Administered orally at 90 mg/m2/day continuously during radiation therapy, held through the interim period and then 200 mg/m2/day for 5 days for up to 10 maintenance cycles |
| OG003 | Cohort 4. MGMT+/EGFR+ | Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles Erlotinib: Administered orally at 85 mg/m2 daily continuously during radiation therapy, through the interim period and for up to 10 maintenance cycles Temozolomide: Administered orally at 90 mg/m2/day continuously during radiation therapy, held through the interim period and then 200 mg/m2/day for 5 days for up to 10 maintenance cycles |
|
|
|
|
| OG002 | Cohort 3. MGMT+/EGFR- | Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles Temozolomide: Administered orally at 90 mg/m2/day continuously during radiation therapy, held through the interim period and then 200 mg/m2/day for 5 days for up to 10 maintenance cycles |
| OG003 | Cohort 4. MGMT+/EGFR+ | Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles Erlotinib: Administered orally at 85 mg/m2 daily continuously during radiation therapy, through the interim period and for up to 10 maintenance cycles |
|
|