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Using MRI-Guided Laser Heat Ablation to Induce Disruption of the Peritumoral Blood Brain Barrier to Enhance Delivery and Efficacy of Treatment of Pediatric Brain Tumors

Primary Purpose

Glioma, Pilocytic Astrocytoma, Anaplastic Astrocytoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MRI-guided laser ablation
Doxorubicin
Etoposide
Dynamic contrast-enhanced (DCE) MRI
Dynamic susceptibility contrast (DSC) MRI
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioma

Eligibility Criteria

3 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

ARM A

  • Presumed pediatric gliomas (grades I-IV) on MRI that are determined to be candidates for MLA by the treating neurosurgeon
  • Age 3 to ≤ 21
  • Karnofsky/Lansky performance status ≥ 60%

ARM B

  • Recurrent pediatric brain tumors determined candidates for MLA as determined by the treating neurosurgeon.
  • Unequivocal evidence of tumor progression by MRI
  • There must be an interval of at least 12 weeks from the completion of radiotherapy to study registration except if there is unequivocal evidence for tumor recurrence per RANO criteria. When the interval is less than 12 weeks from the completion of radiotherapy, the use of PET scan is allowed to differentiate between evidence of tumor recurrence and pseudoprogression.
  • Recurrent lesions with dimension and contour that are determined by the treating neurosurgeon to be appropriate for MLA.
  • Age 3 to ≤ 21
  • Karnofsky/Lansky performance status ≥ 60%
  • Adequate cardiac function as determined by a shortening fraction ≥ 27% or left ventricular ejection fraction ≥ 50% by echocardiogram within the past 1 year prior to registration.
  • Prior anthracycline therapy does not exceed 200 mg/m^2 total cumulative dose.
  • Adequate bone marrow and hepatic function as defined below (must be within 7 days of MLA):

    • Absolute neutrophil count (ANC) ≥ 1000/mcl (G-CSF is allowed)
    • Platelets ≥ 100 K/cumm
    • Hemoglobin ≥ 9 g/dL (pRBC transfusion +/- ESA are allowed)
    • ALT ≤ 3 x ULN
    • AST ≤ 3 x ULN
    • ALP ≤ 3 x ULN. If ALP is > 3 x ULN, GGT must be checked and be ≤ 3 x ULN.
    • Bilirubin ≤ 2 x ULN
  • At the time of registration, patient must have recovered from the toxic effects of prior therapy to no more than grade 1 toxicity.
  • At the time of registration, patient must be at least 4 weeks from other prior cytotoxic chemotherapy.
  • Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
  • Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

ARM A

  • Currently receiving or scheduled to receive any other therapies intended to treat the newly diagnosed glioma prior to MLA and the first post-MLA blood collection for correlative studies.
  • Multi-focal or metastatic disease.
  • Pregnant and/or breastfeeding. Premenopausal women must have a negative serum or urine pregnancy test within 14 days of study entry.
  • Inability to undergo MRI due to personal or medical reasons.
  • Known history of HIV or autoimmune diseases requiring immunosuppressant drugs.

ARM B

  • Prior treatment with bevacizumab within 12 weeks of study entry.
  • Previous treatment with complete cumulative doses of daunorubicin, idarubicin, and/or other anthracyclines and anthracenediones that is equivalent to a total dose of > 200 mg/m2 doxorubicin.
  • More than 2 prior relapses (not counting the current relapse being treated on this study).
  • Currently receiving any other investigational agents that are intended as treatments of the relapsed tumor.
  • Multi-focal or metastatic disease.
  • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to doxorubicin or other agents used in the study.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, recent heart attack within the previous 12 months or severe heart problems, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant and/or breastfeeding. Premenopausal women must have a negative serum or urine pregnancy test within 14 days of study entry.
  • Inability to undergo MRI due to personal or medical reasons.
  • Known history of HIV or autoimmune diseases requiring immunosuppressant drugs.

Sites / Locations

  • Washington University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A (MRI-guided laser ablation)

Arm B (MRI-guided laser ablation, doxorubicin, etoposide)

Arm Description

MLA is a minimally invasive laser surgery currently FDA approved for cytoreductive treatment of brain tumors, both primary and metastatic. MLA employs a small incision in the scalp and skull, through which a thin laser probe is inserted and guided by MR imaging to the core of a tumor mass where it delivers hyperthermic ablation from the core to the rim. Participants will undergo DCE and DSC-MRI imaging at the following time points: no more than 3 weeks prior to MLA (OPTIONAL) within approximately 4 days after MLA 2-4 weeks after MLA Every 12 weeks (+/- 7 days) for the first year or until disease progression

MLA is a minimally invasive laser surgery currently FDA approved for cytoreductive treatment of brain tumors, both primary and metastatic. MLA employs a small incision in the scalp and skull, through which a thin laser probe is inserted and guided by MR imaging to the core of a tumor mass where it delivers hyperthermic ablation from the core to the rim. Within 7 days of MLA (range 2-14 days) doxorubicin will be given intravenously on an outpatient basis weekly for 6 weeks at a dose of 25 mg/m^2 over 5-30 minutes Following the completion of doxorubin, etoposide 50 mg/m^2/day will be given orally for 21 days of each 28-day cycle (treatment can continue up to 24 cycles) Participants will undergo DCE and DSC-MRI imaging at the following time points: no more than 3 weeks prior to MLA (OPTIONAL) within approximately 4 days after MLA 2-4 weeks after MLA every 8 weeks (+/- 7 days) until 2 years have elapsed or disease progression, whichever comes first

Outcomes

Primary Outcome Measures

Arm A only: Progression-free survival (PFS)
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Arm A only: Overall survival (OS)
Arm B only: Progression-free survival (PFS)
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Arm B only: Quality of life (QOL)
-Using Karnofsky or Lansky performance status in patients following MLA and in patients who receive doxorubicin and maintenance etoposide after MLA.

Secondary Outcome Measures

Correlation of MR imaging with peritumoral BBB disruption
The linear regression model will used to investigate the correlation between MR imaging and peritumoral BBB disruption. To account for correlation among the repeated measures from the same patient, the longitudinal data will be analyzed with the use of linear generalized estimating equation (GEE). Whether the average measurements differ at the multiple time points will be evaluated through GEE model. Least-square means at each time points will be presented and standard errors will be calculated within the use of the GEE sandwich method when accounting for within-patient correlation.
Serum biomarkers of peritumoral BBB disruption
Since the investigators do not know which biomarkers will have better correlation with the Ktrans data from DCE and DSC-MRI and patients' survival outcome, the investigators plan to determine the levels of all 3 biomarkers in a blinded fashion. Once both the Ktrans and biomarker levels are available, the investigators will determine which biomarkers have the closest correlation that is statistically significant with the Ktrans. Pearson correlation coefficient (r) will be determined for each biomarker and Ktrans value. Biomarkers with higher correlation coefficient (r approaching 1) will be given higher priority.
Predictive value of the peritumoral permeability score for patient outcome as measured by PFS
Biomarkers with higher correlation coefficient (r approaching 1) will be given higher priority. A minimum r=0.5 is required for inclusion for further analysis and will be used as a peritumoral permeability score. This score will then be correlated with the patient outcome data (as measured by 6 month PFS rate) to determine whether it has a predictive value.

Full Information

First Posted
February 13, 2015
Last Updated
January 29, 2023
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02372409
Brief Title
Using MRI-Guided Laser Heat Ablation to Induce Disruption of the Peritumoral Blood Brain Barrier to Enhance Delivery and Efficacy of Treatment of Pediatric Brain Tumors
Official Title
A Pilot Study of Using MRI-Guided Laser Heat Ablation to Induce Disruption of the Peritumoral Blood Brain Barrier to Enhance Delivery and Efficacy of Treatment of Pediatric Brain Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 14, 2015 (Actual)
Primary Completion Date
August 31, 2030 (Anticipated)
Study Completion Date
August 31, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
By employing a combination of advanced MRI techniques and correlative serum biomarkers of blood brain barrier (BBB) disruption, the investigators plan to develop a powerful, first of its kind clinical algorithm in pediatrics whereby the investigators can measure and identify the window of maximal BBB disruption post MLA to 1) allow for an alternative to surgery in incompletely resected tumors, 2) allow for optimal chemotherapeutic dosing to achieve the greatest benefits and the least systemic side effects and 3) distinguish subsequent tumor progression from long-term MLA treatment effects. Preliminary data in adult imaging studies have shown that the BBB disruption lasts for several weeks following treatment before returning to a low baseline. This pilot therapeutic study will provide preliminary validation in pediatric patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma, Pilocytic Astrocytoma, Anaplastic Astrocytoma, Glioblastoma, Mixed Oligoastrocytoma, Mixed Glioma, Oligodendroglioma, Optic Glioma, Astrocytoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A (MRI-guided laser ablation)
Arm Type
Experimental
Arm Description
MLA is a minimally invasive laser surgery currently FDA approved for cytoreductive treatment of brain tumors, both primary and metastatic. MLA employs a small incision in the scalp and skull, through which a thin laser probe is inserted and guided by MR imaging to the core of a tumor mass where it delivers hyperthermic ablation from the core to the rim. Participants will undergo DCE and DSC-MRI imaging at the following time points: no more than 3 weeks prior to MLA (OPTIONAL) within approximately 4 days after MLA 2-4 weeks after MLA Every 12 weeks (+/- 7 days) for the first year or until disease progression
Arm Title
Arm B (MRI-guided laser ablation, doxorubicin, etoposide)
Arm Type
Experimental
Arm Description
MLA is a minimally invasive laser surgery currently FDA approved for cytoreductive treatment of brain tumors, both primary and metastatic. MLA employs a small incision in the scalp and skull, through which a thin laser probe is inserted and guided by MR imaging to the core of a tumor mass where it delivers hyperthermic ablation from the core to the rim. Within 7 days of MLA (range 2-14 days) doxorubicin will be given intravenously on an outpatient basis weekly for 6 weeks at a dose of 25 mg/m^2 over 5-30 minutes Following the completion of doxorubin, etoposide 50 mg/m^2/day will be given orally for 21 days of each 28-day cycle (treatment can continue up to 24 cycles) Participants will undergo DCE and DSC-MRI imaging at the following time points: no more than 3 weeks prior to MLA (OPTIONAL) within approximately 4 days after MLA 2-4 weeks after MLA every 8 weeks (+/- 7 days) until 2 years have elapsed or disease progression, whichever comes first
Intervention Type
Device
Intervention Name(s)
MRI-guided laser ablation
Other Intervention Name(s)
MLA
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Other Intervention Name(s)
Adriamycin
Intervention Type
Drug
Intervention Name(s)
Etoposide
Other Intervention Name(s)
Etoposide phosphate, VP-16, Toposar, Etopophos, VePesid
Intervention Type
Device
Intervention Name(s)
Dynamic contrast-enhanced (DCE) MRI
Other Intervention Name(s)
DCE-MRI
Intervention Type
Device
Intervention Name(s)
Dynamic susceptibility contrast (DSC) MRI
Other Intervention Name(s)
DSC-MRI
Primary Outcome Measure Information:
Title
Arm A only: Progression-free survival (PFS)
Description
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Time Frame
Up to 5 years
Title
Arm A only: Overall survival (OS)
Time Frame
Up to 5 years
Title
Arm B only: Progression-free survival (PFS)
Description
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Time Frame
6 months
Title
Arm B only: Quality of life (QOL)
Description
-Using Karnofsky or Lansky performance status in patients following MLA and in patients who receive doxorubicin and maintenance etoposide after MLA.
Time Frame
1 year from MLA
Secondary Outcome Measure Information:
Title
Correlation of MR imaging with peritumoral BBB disruption
Description
The linear regression model will used to investigate the correlation between MR imaging and peritumoral BBB disruption. To account for correlation among the repeated measures from the same patient, the longitudinal data will be analyzed with the use of linear generalized estimating equation (GEE). Whether the average measurements differ at the multiple time points will be evaluated through GEE model. Least-square means at each time points will be presented and standard errors will be calculated within the use of the GEE sandwich method when accounting for within-patient correlation.
Time Frame
1 year from MLA
Title
Serum biomarkers of peritumoral BBB disruption
Description
Since the investigators do not know which biomarkers will have better correlation with the Ktrans data from DCE and DSC-MRI and patients' survival outcome, the investigators plan to determine the levels of all 3 biomarkers in a blinded fashion. Once both the Ktrans and biomarker levels are available, the investigators will determine which biomarkers have the closest correlation that is statistically significant with the Ktrans. Pearson correlation coefficient (r) will be determined for each biomarker and Ktrans value. Biomarkers with higher correlation coefficient (r approaching 1) will be given higher priority.
Time Frame
1 year from MLA
Title
Predictive value of the peritumoral permeability score for patient outcome as measured by PFS
Description
Biomarkers with higher correlation coefficient (r approaching 1) will be given higher priority. A minimum r=0.5 is required for inclusion for further analysis and will be used as a peritumoral permeability score. This score will then be correlated with the patient outcome data (as measured by 6 month PFS rate) to determine whether it has a predictive value.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ARM A Presumed pediatric gliomas (grades I-IV) on MRI that are determined to be candidates for MLA by the treating neurosurgeon Age 3 to ≤ 21 Karnofsky/Lansky performance status ≥ 60% ARM B Recurrent pediatric brain tumors determined candidates for MLA as determined by the treating neurosurgeon. Unequivocal evidence of tumor progression by MRI There must be an interval of at least 12 weeks from the completion of radiotherapy to study registration except if there is unequivocal evidence for tumor recurrence per RANO criteria. When the interval is less than 12 weeks from the completion of radiotherapy, the use of PET scan is allowed to differentiate between evidence of tumor recurrence and pseudoprogression. Recurrent lesions with dimension and contour that are determined by the treating neurosurgeon to be appropriate for MLA. Age 3 to ≤ 21 Karnofsky/Lansky performance status ≥ 60% Adequate cardiac function as determined by a shortening fraction ≥ 27% or left ventricular ejection fraction ≥ 50% by echocardiogram within the past 1 year prior to registration. Prior anthracycline therapy does not exceed 200 mg/m^2 total cumulative dose. Adequate bone marrow and hepatic function as defined below (must be within 7 days of MLA): Absolute neutrophil count (ANC) ≥ 1000/mcl (G-CSF is allowed) Platelets ≥ 100 K/cumm Hemoglobin ≥ 9 g/dL (pRBC transfusion +/- ESA are allowed) ALT ≤ 3 x ULN AST ≤ 3 x ULN ALP ≤ 3 x ULN. If ALP is > 3 x ULN, GGT must be checked and be ≤ 3 x ULN. Bilirubin ≤ 2 x ULN At the time of registration, patient must have recovered from the toxic effects of prior therapy to no more than grade 1 toxicity. At the time of registration, patient must be at least 4 weeks from other prior cytotoxic chemotherapy. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable). Exclusion Criteria: ARM A Currently receiving or scheduled to receive any other therapies intended to treat the newly diagnosed glioma prior to MLA and the first post-MLA blood collection for correlative studies. Multi-focal or metastatic disease. Pregnant and/or breastfeeding. Premenopausal women must have a negative serum or urine pregnancy test within 14 days of study entry. Inability to undergo MRI due to personal or medical reasons. Known history of HIV or autoimmune diseases requiring immunosuppressant drugs. ARM B Prior treatment with bevacizumab within 12 weeks of study entry. Previous treatment with complete cumulative doses of daunorubicin, idarubicin, and/or other anthracyclines and anthracenediones that is equivalent to a total dose of > 200 mg/m2 doxorubicin. More than 2 prior relapses (not counting the current relapse being treated on this study). Currently receiving any other investigational agents that are intended as treatments of the relapsed tumor. Multi-focal or metastatic disease. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to doxorubicin or other agents used in the study. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, recent heart attack within the previous 12 months or severe heart problems, or psychiatric illness/social situations that would limit compliance with study requirements. Pregnant and/or breastfeeding. Premenopausal women must have a negative serum or urine pregnancy test within 14 days of study entry. Inability to undergo MRI due to personal or medical reasons. Known history of HIV or autoimmune diseases requiring immunosuppressant drugs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margaret Shatara, M.D.
Phone
314-454-6018
Email
shatara@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Shatara, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret Shatara, M.D.
Phone
314-454-6018
Email
shatara@wustl.edu
First Name & Middle Initial & Last Name & Degree
Margaret Shatara, M.D.
First Name & Middle Initial & Last Name & Degree
David Limbrick, M.D.
First Name & Middle Initial & Last Name & Degree
Joshua Shimony, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Allison King, M.D., M.P.H.
First Name & Middle Initial & Last Name & Degree
Eric Leuthardt, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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10602854
Citation
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Ashley DM, Meier L, Kerby T, Zalduondo FM, Friedman HS, Gajjar A, Kun L, Duffner PK, Smith S, Longee D. Response of recurrent medulloblastoma to low-dose oral etoposide. J Clin Oncol. 1996 Jun;14(6):1922-7. doi: 10.1200/JCO.1996.14.6.1922.
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Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

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Using MRI-Guided Laser Heat Ablation to Induce Disruption of the Peritumoral Blood Brain Barrier to Enhance Delivery and Efficacy of Treatment of Pediatric Brain Tumors

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