Recurrent GBM Treated With Neurosurgical Resection and IORT Using the Xoft Axxent eBx System and Bevacizumab
NCT ID: NCT04681677
Last Updated: 2024-04-26
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE2
Total Enrollment
12 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-11-02
Study Completion Date
2024-04-24
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Glioblastoma
Recurrent Glioblastoma
GBM
Recurrent GBM
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
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.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Experimental: Intra-operative Radiation Therapy - IORT
Radiation: Intra-operative Radiation Therapy - IORT
Group Type
EXPERIMENTAL
Radiation: Intra-operative Radiation Therapy - IORT
Intervention Type
RADIATION
Single fraction, Intra-operative Radiation Therapy at the time of surgical resection of recurrent GBM followed by Bevacizumab 28-56 days after surgery.
Bevacizumab
Intervention Type
DRUG
Bevacizumab
Interventions
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Radiation: Intra-operative Radiation Therapy - IORT
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
RADIATION
Bevacizumab
Bevacizumab
Intervention Type
DRUG
Other Intervention Names
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Avastin
Eligibility Criteria
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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
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
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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Icad, Inc.
INDUSTRY
Sponsor Role
collaborator
Xoft, Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Santosh Kesari, MD
Role: PRINCIPAL_INVESTIGATOR
Saint John's Cancer Institute
Locations
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Providence Saint John's Health Center
Santa Monica, California, United States
Site Status
Countries
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United States
References
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Louis DN, Perry A, Reifenberger G, von Deimling A, Figarella-Branger D, Cavenee WK, Ohgaki H, Wiestler OD, Kleihues P, Ellison DW. The 2016 World Health Organization Classification of Tumors of the Central Nervous System: a summary. Acta Neuropathol. 2016 Jun;131(6):803-20. doi: 10.1007/s00401-016-1545-1. Epub 2016 May 9.
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Stupp R, Tonn JC, Brada M, Pentheroudakis G; ESMO Guidelines Working Group. High-grade malignant glioma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2010 May;21 Suppl 5:v190-3. doi: 10.1093/annonc/mdq187. No abstract available.
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BACKGROUND
Haj A, Doenitz C, Schebesch KM, Ehrensberger D, Hau P, Putnik K, Riemenschneider MJ, Wendl C, Gerken M, Pukrop T, Brawanski A, Proescholdt MA. Extent of Resection in Newly Diagnosed Glioblastoma: Impact of a Specialized Neuro-Oncology Care Center. Brain Sci. 2017 Dec 25;8(1):5. doi: 10.3390/brainsci8010005.
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Hardesty DA, Sanai N. The value of glioma extent of resection in the modern neurosurgical era. Front Neurol. 2012 Oct 18;3:140. doi: 10.3389/fneur.2012.00140. eCollection 2012.
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Krivoshapkin AL, Sergeev GS, Gaytan AS, Kurbatov VP, Kalneus LE, Tarantsev EG. New software for objective evaluation of brain glioblastoma resection degree. Zh Vopr Neirokhir Im N N Burdenko. 2014;78(5):33-9; discussion 40. English, Russian.
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BACKGROUND
Davis ME. Glioblastoma: Overview of Disease and Treatment. Clin J Oncol Nurs. 2016 Oct 1;20(5 Suppl):S2-8. doi: 10.1188/16.CJON.S1.2-8.
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Gaspar LE, Fisher BJ, Macdonald DR, LeBer DV, Halperin EC, Schold SC Jr, Cairncross JG. Supratentorial malignant glioma: patterns of recurrence and implications for external beam local treatment. Int J Radiat Oncol Biol Phys. 1992;24(1):55-7. doi: 10.1016/0360-3016(92)91021-e.
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Choucair AK, Levin VA, Gutin PH, Davis RL, Silver P, Edwards MS, Wilson CB. Development of multiple lesions during radiation therapy and chemotherapy in patients with gliomas. J Neurosurg. 1986 Nov;65(5):654-8. doi: 10.3171/jns.1986.65.5.0654.
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Mallick S, Benson R, Hakim A, Rath GK. Management of glioblastoma after recurrence: A changing paradigm. J Egypt Natl Canc Inst. 2016 Dec;28(4):199-210. doi: 10.1016/j.jnci.2016.07.001. Epub 2016 Jul 28.
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Weller M, van den Bent M, Tonn JC, Stupp R, Preusser M, Cohen-Jonathan-Moyal E, Henriksson R, Le Rhun E, Balana C, Chinot O, Bendszus M, Reijneveld JC, Dhermain F, French P, Marosi C, Watts C, Oberg I, Pilkington G, Baumert BG, Taphoorn MJB, Hegi M, Westphal M, Reifenberger G, Soffietti R, Wick W; European Association for Neuro-Oncology (EANO) Task Force on Gliomas. European Association for Neuro-Oncology (EANO) guideline on the diagnosis and treatment of adult astrocytic and oligodendroglial gliomas. Lancet Oncol. 2017 Jun;18(6):e315-e329. doi: 10.1016/S1470-2045(17)30194-8. Epub 2017 May 5.
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van Linde ME, Brahm CG, de Witt Hamer PC, Reijneveld JC, Bruynzeel AME, Vandertop WP, van de Ven PM, Wagemakers M, van der Weide HL, Enting RH, Walenkamp AME, Verheul HMW. Treatment outcome of patients with recurrent glioblastoma multiforme: a retrospective multicenter analysis. J Neurooncol. 2017 Oct;135(1):183-192. doi: 10.1007/s11060-017-2564-z. Epub 2017 Jul 20.
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Landy HJ, Feun L, Schwade JG, Snodgrass S, Lu Y, Gutman F. Retreatment of intracranial gliomas. South Med J. 1994 Feb;87(2):211-4. doi: 10.1097/00007611-199402000-00013.
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Ammirati M, Galicich JH, Arbit E, Liao Y. Reoperation in the treatment of recurrent intracranial malignant gliomas. Neurosurgery. 1987 Nov;21(5):607-14. doi: 10.1227/00006123-198711000-00001.
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Harsh GR 4th, Levin VA, Gutin PH, Seager M, Silver P, Wilson CB. Reoperation for recurrent glioblastoma and anaplastic astrocytoma. Neurosurgery. 1987 Nov;21(5):615-21. doi: 10.1227/00006123-198711000-00002.
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Pace A, Dirven L, Koekkoek JAF, Golla H, Fleming J, Ruda R, Marosi C, Le Rhun E, Grant R, Oliver K, Oberg I, Bulbeck HJ, Rooney AG, Henriksson R, Pasman HRW, Oberndorfer S, Weller M, Taphoorn MJB; European Association of Neuro-Oncology palliative care task force. European Association for Neuro-Oncology (EANO) guidelines for palliative care in adults with glioma. Lancet Oncol. 2017 Jun;18(6):e330-e340. doi: 10.1016/S1470-2045(17)30345-5.
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Scanderbeg DJ, Alksne JF, Lawson JD, Murphy KT. Novel use of the Contura for high dose rate cranial brachytherapy. Med Dosim. 2011 Winter;36(4):344-6. doi: 10.1016/j.meddos.2010.08.001. Epub 2010 Dec 8.
Reference Type
BACKGROUND
Other Identifiers
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CTPR-0017
Identifier Type: -
Identifier Source: org_study_id
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COMPLETED
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Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma
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COMPLETED
PHASE2
Optune® Plus Bevacizumab in Bevacizumab-Refractory Recurrent Glioblastoma
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TERMINATED
PHASE2