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Recurrent GBM Treated With Neurosurgical Resection and IORT Using the Xoft Axxent eBx System and Bevacizumab (IORT)

Primary Purpose

Glioblastoma, Recurrent Glioblastoma, GBM

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Radiation: Intra-operative Radiation Therapy - IORT
Bevacizumab
Avastin
Sponsored by
Xoft, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring Bevacizumab, Glioblastoma, Recurrent Glioblastoma, GBM, Recurrent GBM, IORT, Intra-Operative Radiation Therapy, Avastin

Eligibility Criteria

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

Inclusion Criteria:

  1. Subject has the ability to provide written informed consent
  2. Subject has the willingness to comply with all study procedures for the duration of the study
  3. Subject has histopathologically proven diagnosis of GBM or variants (gliosarcoma, giant cell glioblastoma etc.). Subjects will be also eligible if the original histology was lower-grade glioma and a subsequent diagnosis of glioblastoma or gliosarcoma is made.
  4. Subjects must have shown unequivocal radiographic evidence for tumor progression by contrast-enhanced MRI within 21 days prior to enrollment
  5. Subjects must have passed an interval of 6 months or greater between completion of prior radiotherapy and enrollment. If subjects have not passed an interval of at least 6 months, they may still be eligible if they meet one or more of the following criteria:

    1. New areas of tumor outside the original radiotherapy fields as determined by the investigator, or
    2. Histologic confirmation of tumor through biopsy or resection, or
    3. Nuclear medicine imaging, MR spectroscopy, or MR perfusion imaging consistent with true progressive disease, rather than radiation necrosis obtained within 28 days of registration AND an interval of at least 90 days between completion of radiotherapy and enrollment
  6. The recurrent GBM must be potentially-resectable with the intent to resect such that residual tumor rim is less than 1 cm enhancing disease
  7. The recurrent GBM must have the appropriate dimensions to allow a Xoft applicator balloon to fit into the tumor cavity
  8. Subject has prior history of standard dose CNS radiation of 60 Gy in 30 fractions or 59.4 Gy in 1.8 Gy fractions, or equivalent of lower doses. Patients who have received prior treatment with non-standard RT dose and fractionation, interstitial brachytherapy, stereotactic radiosurgery, etc. are eligible as long as the criterion in 5. is met or approved by principal investigator.
  9. Subjects who have undergone CNS related core or needle biopsies, a minimum of 7 days must have elapsed prior to registration
  10. History/physical examination, including neurologic examination, within 14 days prior to enrollment (i.e. date the informed consent was signed by the patient)
  11. Subject must be ≥ 18 years of age
  12. Subject must have a Karnofsky Performance Score ≥ 60%
  13. Subject will have had a CBC/differential obtained within 14 days prior to enrollment , with adequate bone marrow function, i.e.:

    d) Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3 e) Platelets ≥ 75,000 cells/mm3 f) Hemoglobin ≥ 9.0 g/dl (The use of transfusion or other intervention to achieve Hgb ≥ 9.0 g/dl is acceptable.)

  14. Subjects liver and renal function test should reflect adequate hepatic and renal function 14 days prior to enrollment, i.e.:

    1. Total bilirubin ≤ 2.0 mg/dL, and SGOT or AST ≤ 2.5 times the upper limit of normal
    2. Serum creatinine ≤ 1.8 mg/dL) within 14 days prior to enrollment
  15. Subject urine protein level must reflect the following requirements within 14 days before enrollment:

    1. Urine protein: creatinine (UPC ) ratio < 1.0 OR
    2. Urine dipstick for proteinuria ≤ 2+ (patients who have > 2+ proteinuria on dipstick urinalysis at baseline, must have an UPC ratio <1.0 to be eligible. If the UPC ratio is ≥ 1.0, subsequent 24 hrs urine collection must be ≤ 1 g protein in 24 hrs)
  16. Patients on full-dose anticoagulants (e.g., warfarin or LMW heparin) must meet both of the following criteria:

    1. No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices).
    2. In-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin, within 14 days prior to enrollment.
  17. Women of child-bearing potential must have a negative pregnancy test within 7 days of treatment
  18. Subjects of child-bearing potential must agree to use adequate contraceptive precautions and not to breastfeed (if applicable) until six months after the end of the treatment with Bevacizumab.
  19. Patient is planned to have surgery for recurrent Glioblastoma

Exclusion Criteria:

  1. Subject has had more than three relapses
  2. Subject has multi-centric disease
  3. Subject has tumors in or near (less than 10mm from tumor margin) critical brain structures, that would exclude sufficient dose delivery to the tumor margin:

    1. Optic Chiasm
    2. Optic Nerve
  4. Subject has infratentorial, or leptomeningeal evidence of recurrent disease
  5. Subject has recurrent or persistent tumor greater than 6 cm in maximum diameter
  6. Subject underwent prior therapy with an inhibitor of VEGF or VEGFR (including Bevacizumab)
  7. Subject suffered from prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1 year (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
  8. Women who are pregnant or nursing. Women with child-bearing potential or sexually active men that are not willing/able to use medically acceptable forms of contraception.
  9. Subject has contraindications for MRI with or without gadolinium.
  10. Subject has contraindications for anesthesia or surgery.
  11. Subject is on another therapeutic clinical trial concurrently.
  12. Subject suffers severe, active co-morbidity, defined as follows:

    1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to enrollment
    2. Transmural myocardial infarction within the last 6 months prior to enrollment
    3. History of stroke or transient ischemic attack within 6 months prior to enrollment
    4. Significant vascular (aortic) disease or clinically significant peripheral vascular disease
    5. Active venous or arterial thromboembolic disease
    6. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of enrollment
    7. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of enrollment
    8. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects. Laboratory tests for liver function other than screening panel coagulation parameters are not required for entry into this protocol
    9. Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition. HIV testing is not required for entry into this protocol.
  13. Prior history of hypertensive crisis or hypertensive encephalopathy
  14. Subject has history of a non-healing wound, ulcer, or bone fracture within 90 days (3 months) prior to enrollment
  15. Subject suffers from gastrointestinal bleeding or any other hemorrhage /bleeding event CTCAE v.5 grade 3 or greater within 30 days prior to enrollment
  16. Subject suffers from Hypersensitivity to Bevacizumab

Sites / Locations

  • Providence Saint John's Health CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: Intra-operative Radiation Therapy - IORT

Arm Description

Radiation: Intra-operative Radiation Therapy - IORT

Outcomes

Primary Outcome Measures

median overall survival (mOS)
The median overall survival (mOS) of subjects treated with the Xoft Axxent Electronic Brachytherapy (eBx)® System when used for single-fraction, intra-operative radiation therapy (IORT) following maximal safe neurosurgical resection of recurrent glioblastoma and bevacizumab and compare it to the EBRT + Bevacizumab arm of RTOG 1205.

Secondary Outcome Measures

6 Month rate progression-free survival (PFS)
To assess progression-free survival and compare it to the EBRT + Bevacizumab arm of RTOG 1205.
tumor progression at four weeks
To assess the tumor progression in the first four weeks after surgery
Local and distant progression-free survival
To assess local and distant progression free survival
Quality of Life and radiation-related neurotoxicity
To assess Quality of Life (QOL) and radiation-related neurotoxicity and compare it to the EBRT + Bevacizumab arm of RTOG 1205.
Rate of adverse events/safety
To assess the rate of adverse events/ safety and compare it to the EBRT + Bevacizumab arm of RTOG 1205

Full Information

First Posted
December 17, 2020
Last Updated
July 14, 2022
Sponsor
Xoft, Inc.
Collaborators
Icad, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04681677
Brief Title
Recurrent GBM Treated With Neurosurgical Resection and IORT Using the Xoft Axxent eBx System and Bevacizumab
Acronym
IORT
Official Title
Phase II Study of Patients With Recurrent Glioblastoma Multiforme Treated With Maximal Safe Neurosurgical Resection and Intra-Operative Radiation Therapy (IORT) Using the Xoft Axxent Electronic Brachytherapy System and Bevacizumab
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2021 (Actual)
Primary Completion Date
November 2026 (Anticipated)
Study Completion Date
February 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xoft, Inc.
Collaborators
Icad, Inc.

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this trial is to assess the overall survival of patients treated with the Xoft Axxent eBx System and post-radiation adjuvant Bevacizumab for single-fraction IORT following maximal neurosurgical resection of recurrent glioblastoma. A historical comparison will be made to the results of the EBRT + Bevacizumab arm of RTOG 1205.
Detailed Description
The rationale for IORT, as the sole radiation therapy following surgical resection of recurrent GBM is to expand upon the favorable preliminary results in feasibility, safety and efficacy outcomes obtained at the European Medical Center Study Group (EMC Study Group). The rationale to add Bevacizumab as a systemic treatment is to target radio-resistant and highly tumorigenic cancer stem cells as well as to benefit from its radioprotective effects, i.e. reducing risk of radiation necrosis. Lastly, using Bevacizumab as a systemic therapy will enable the comparison of the results to the historic control arm, the EBRT arm of RTOG 1205.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma, Recurrent Glioblastoma, GBM, Recurrent GBM
Keywords
Bevacizumab, Glioblastoma, Recurrent Glioblastoma, GBM, Recurrent GBM, IORT, Intra-Operative Radiation Therapy, Avastin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Single arm, prospective, multi-center, non-randomized, historical control, non-inferiority study of subjects treated with single fraction, Intra-Operative Radiation Therapy at the time of maximal resection for recurrent GBM. Treatment with Bevacizumab will be initiated 28-56 days after surgery depending on surgical wound healing assessment at the discretion of the treating investigator.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Intra-operative Radiation Therapy - IORT
Arm Type
Experimental
Arm Description
Radiation: Intra-operative Radiation Therapy - IORT
Intervention Type
Radiation
Intervention Name(s)
Radiation: Intra-operative Radiation Therapy - IORT
Intervention Description
Single fraction, Intra-operative Radiation Therapy at the time of surgical resection of recurrent GBM followed by Bevacizumab 28-56 days after surgery.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
Bevacizumab
Intervention Type
Drug
Intervention Name(s)
Avastin
Intervention Description
Avastin
Primary Outcome Measure Information:
Title
median overall survival (mOS)
Description
The median overall survival (mOS) of subjects treated with the Xoft Axxent Electronic Brachytherapy (eBx)® System when used for single-fraction, intra-operative radiation therapy (IORT) following maximal safe neurosurgical resection of recurrent glioblastoma and bevacizumab and compare it to the EBRT + Bevacizumab arm of RTOG 1205.
Time Frame
3 Years
Secondary Outcome Measure Information:
Title
6 Month rate progression-free survival (PFS)
Description
To assess progression-free survival and compare it to the EBRT + Bevacizumab arm of RTOG 1205.
Time Frame
6 Month
Title
tumor progression at four weeks
Description
To assess the tumor progression in the first four weeks after surgery
Time Frame
4 Weeks
Title
Local and distant progression-free survival
Description
To assess local and distant progression free survival
Time Frame
3 Years
Title
Quality of Life and radiation-related neurotoxicity
Description
To assess Quality of Life (QOL) and radiation-related neurotoxicity and compare it to the EBRT + Bevacizumab arm of RTOG 1205.
Time Frame
3 Years
Title
Rate of adverse events/safety
Description
To assess the rate of adverse events/ safety and compare it to the EBRT + Bevacizumab arm of RTOG 1205
Time Frame
3 Years
Other Pre-specified Outcome Measures:
Title
imaging changes
Description
To characterize the pattern of failure based on a centralized MRI review
Time Frame
3 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has the ability to provide written informed consent Subject has the willingness to comply with all study procedures for the duration of the study Subject has histopathologically proven diagnosis of GBM or variants (gliosarcoma, giant cell glioblastoma etc.). Subjects will be also eligible if the original histology was lower-grade glioma and a subsequent diagnosis of glioblastoma or gliosarcoma is made. Subjects must have shown unequivocal radiographic evidence for tumor progression by contrast-enhanced MRI within 21 days prior to enrollment Subjects must have passed an interval of 6 months or greater between completion of prior radiotherapy and enrollment. If subjects have not passed an interval of at least 6 months, they may still be eligible if they meet one or more of the following criteria: New areas of tumor outside the original radiotherapy fields as determined by the investigator, or Histologic confirmation of tumor through biopsy or resection, or Nuclear medicine imaging, MR spectroscopy, or MR perfusion imaging consistent with true progressive disease, rather than radiation necrosis obtained within 28 days of registration AND an interval of at least 90 days between completion of radiotherapy and enrollment The recurrent GBM must be potentially-resectable with the intent to resect such that residual tumor rim is less than 1 cm enhancing disease The recurrent GBM must have the appropriate dimensions to allow a Xoft applicator balloon to fit into the tumor cavity Subject has prior history of standard dose CNS radiation of 60 Gy in 30 fractions or 59.4 Gy in 1.8 Gy fractions, or equivalent of lower doses. Patients who have received prior treatment with non-standard RT dose and fractionation, interstitial brachytherapy, stereotactic radiosurgery, etc. are eligible as long as the criterion in 5. is met or approved by principal investigator. Subjects who have undergone CNS related core or needle biopsies, a minimum of 7 days must have elapsed prior to registration History/physical examination, including neurologic examination, within 14 days prior to enrollment (i.e. date the informed consent was signed by the patient) Subject must be ≥ 18 years of age Subject must have a Karnofsky Performance Score ≥ 60% Subject will have had a CBC/differential obtained within 14 days prior to enrollment , with adequate bone marrow function, i.e.: d) Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3 e) Platelets ≥ 75,000 cells/mm3 f) Hemoglobin ≥ 9.0 g/dl (The use of transfusion or other intervention to achieve Hgb ≥ 9.0 g/dl is acceptable.) Subjects liver and renal function test should reflect adequate hepatic and renal function 14 days prior to enrollment, i.e.: Total bilirubin ≤ 2.0 mg/dL, and SGOT or AST ≤ 2.5 times the upper limit of normal Serum creatinine ≤ 1.8 mg/dL) within 14 days prior to enrollment Subject urine protein level must reflect the following requirements within 14 days before enrollment: Urine protein: creatinine (UPC ) ratio < 1.0 OR Urine dipstick for proteinuria ≤ 2+ (patients who have > 2+ proteinuria on dipstick urinalysis at baseline, must have an UPC ratio <1.0 to be eligible. If the UPC ratio is ≥ 1.0, subsequent 24 hrs urine collection must be ≤ 1 g protein in 24 hrs) Patients on full-dose anticoagulants (e.g., warfarin or LMW heparin) must meet both of the following criteria: No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices). In-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin, within 14 days prior to enrollment. Women of child-bearing potential must have a negative pregnancy test within 7 days of treatment Subjects of child-bearing potential must agree to use adequate contraceptive precautions and not to breastfeed (if applicable) until six months after the end of the treatment with Bevacizumab. Patient is planned to have surgery for recurrent Glioblastoma Exclusion Criteria: Subject has had more than three relapses Subject has multi-centric disease Subject has tumors in or near (less than 10mm from tumor margin) critical brain structures, that would exclude sufficient dose delivery to the tumor margin: Optic Chiasm Optic Nerve Subject has infratentorial, or leptomeningeal evidence of recurrent disease Subject has recurrent or persistent tumor greater than 6 cm in maximum diameter Subject underwent prior therapy with an inhibitor of VEGF or VEGFR (including Bevacizumab) Subject suffered from prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1 year (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible). Women who are pregnant or nursing. Women with child-bearing potential or sexually active men that are not willing/able to use medically acceptable forms of contraception. Subject has contraindications for MRI with or without gadolinium. Subject has contraindications for anesthesia or surgery. Subject is on another therapeutic clinical trial concurrently. Subject suffers severe, active co-morbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to enrollment Transmural myocardial infarction within the last 6 months prior to enrollment History of stroke or transient ischemic attack within 6 months prior to enrollment Significant vascular (aortic) disease or clinically significant peripheral vascular disease Active venous or arterial thromboembolic disease Acute bacterial or fungal infection requiring intravenous antibiotics at the time of enrollment Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of enrollment Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects. Laboratory tests for liver function other than screening panel coagulation parameters are not required for entry into this protocol Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition. HIV testing is not required for entry into this protocol. Prior history of hypertensive crisis or hypertensive encephalopathy Subject has history of a non-healing wound, ulcer, or bone fracture within 90 days (3 months) prior to enrollment Subject suffers from gastrointestinal bleeding or any other hemorrhage /bleeding event CTCAE v.5 grade 3 or greater within 30 days prior to enrollment Subject suffers from Hypersensitivity to Bevacizumab
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Crystal Snyder
Phone
937-503-8588
Email
csnyder@icadmed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Santosh Kesari, MD
Organizational Affiliation
Saint John's Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence Saint John's Health Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Chacon, BSN, RN
Phone
310-582-7097
Email
emma.f.chacon@providence.org
First Name & Middle Initial & Last Name & Degree
Naveed Wagle, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared
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Recurrent GBM Treated With Neurosurgical Resection and IORT Using the Xoft Axxent eBx System and Bevacizumab

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