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Virus Therapy
VB-111 + Surgery/Bevacizumab for Glioblastoma
Phase 2
Waitlist Available
Led By Patrick Wen, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate bone marrow, liver, and renal function according to the following criteria: Absolute neutrophil count ≥ 1,500 cells/mL ~ 1.5 K/μL Platelets ≥ 100,000 cells/mL ~ 100 K/μL Total bilirubin ≤ 1.5 X institutional ULN OR Direct bilirubin ≤ institutional ULN for subjects with total bilirubin levels > 1.5 institutional ULN Aspartate aminotransferase (AST) ≤ 2.0 x ULN Serum creatinine level ≤ ULN or creatinine clearance ≥ 50 mL/min for participants with creatinine levels above normal limits (calculated by the Cockcroft-Gault formula)
Surgically resectable disease at progression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from randomization until death from any cause up to 6 years
Awards & highlights
Study Summary
This trial is testing a new brain cancer therapy to see if it can help patients whose cancer is growing or progressing despite earlier treatment.
Who is the study for?
Adults with Grade IV malignant glioma (glioblastoma or gliosarcoma) experiencing their first or second progression post-radiation treatment, who have a measurable disease and surgically resectable tumors. Participants must be in good physical condition (KPS ≥ 70%), have proper organ function, agree to use contraception, and not be pregnant. They should not have had recent surgeries that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing VB-111, a new viral therapy for recurrent/progressive brain tumors against a placebo. It involves surgery as part of the treatment process. Some participants will also receive Bevacizumab, an existing cancer drug. The goal is to see if VB-111 can improve outcomes for these patients.See study design
What are the potential side effects?
Potential side effects include typical reactions associated with viral therapies such as flu-like symptoms, fatigue, fever, chills and nausea; surgical risks like infection; and Bevacizumab-related issues including hypertension, bleeding or clotting problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood, liver, and kidney functions are within normal ranges.
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My disease can be surgically removed if it gets worse.
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I have been diagnosed with a Grade IV brain tumor (glioblastoma or gliosarcoma).
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I am 18 years old or older.
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I am mostly able to take care of myself.
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My brain cancer has worsened for the first or second time after initial treatment.
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My brain cancer has worsened for the first or second time after initial treatment.
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My kidney function is within normal limits or moderately reduced.
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My tumor is 4cm or smaller in its longest dimension.
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It has been over 23 days since my last chemotherapy session.
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My tumor is 4cm or smaller in its longest dimension.
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I have been diagnosed with a Grade IV brain tumor (glioblastoma or gliosarcoma).
Select...
My disease can be surgically removed if it gets worse.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from randomization until death from any cause up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from randomization until death from any cause up to 6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Dose Limiting Toxicity
Tumor infiltrating T cell (TIL) density
Secondary outcome measures
6-month progression-free survival
Overall Survival
Side effects data
From 2023 Phase 3 trial • 521 Patients • NCT0410906665%
Alopecia
48%
Nausea
36%
Anaemia
26%
Fatigue
25%
Aspartate aminotransferase increased
24%
Diarrhoea
21%
Alanine aminotransferase increased
20%
Vomiting
20%
Asthenia
19%
Headache
19%
Neuropathy peripheral
19%
Neutropenia
17%
Constipation
16%
COVID-19
16%
Neutrophil count decreased
15%
Arthralgia
14%
Rash
13%
Decreased appetite
13%
Hypothyroidism
12%
Hyperglycaemia
12%
White blood cell count decreased
12%
Radiation skin injury
11%
Lymphopenia
11%
Myalgia
9%
Pruritus
9%
Infusion related reaction
9%
Cough
9%
Pyrexia
9%
Urinary tract infection
9%
Epistaxis
9%
Hypertension
8%
Blood alkaline phosphatase increased
7%
Dizziness
7%
Dyspepsia
7%
Dysgeusia
7%
Hot flush
6%
Peripheral sensory neuropathy
6%
Abdominal pain upper
6%
Back pain
6%
Pain in extremity
6%
Paraesthesia
6%
Illness
6%
Mucosal inflammation
6%
Leukopenia
6%
Hypersensitivity
6%
Hyperthyroidism
6%
Insomnia
5%
Weight decreased
5%
Blood lactate dehydrogenase increased
5%
Anxiety
5%
Folliculitis
4%
Abdominal pain
4%
Blood thyroid stimulating hormone increased
4%
Dry mouth
4%
Adrenal insufficiency
4%
Oedema peripheral
4%
Pain
3%
Dyspnoea
3%
Blood thyroid stimulating hormone decreased
3%
Hyponatraemia
3%
Stomatitis
3%
Dry eye
3%
Lacrimation increased
3%
Gastrooesophageal reflux disease
3%
Nasopharyngitis
3%
Lymphocyte count decreased
3%
Hypokalaemia
2%
Breast pain
2%
Nail disorder
2%
Postoperative wound infection
2%
Bone pain
2%
Pulmonary embolism
2%
Thrombocytopenia
2%
Depression
2%
Malignant neoplasm progression
2%
Rash maculo-papular
2%
Palpitations
2%
Dry skin
2%
Onycholysis
2%
Febrile neutropenia
2%
COVID-19 pneumonia
2%
Tachycardia
2%
Procedural pain
2%
Oropharyngeal pain
1%
Embolism
1%
Left ventricular failure
1%
Thyroiditis subacute
1%
Interstitial lung disease
1%
Cardiac perfusion defect
1%
Pneumonia bacterial
1%
Upper respiratory tract infection
1%
Cardiac failure
1%
Vertigo
1%
Myocarditis
1%
Cervix carcinoma
1%
Pemphigoid
1%
Immune-mediated adrenal insufficiency
1%
Hypotension
1%
Chills
1%
Pneumonia
1%
Myelosuppression
1%
Intracranial pressure increased
1%
Cardio-respiratory arrest
1%
Myocardial infarction
1%
Colitis
1%
Anaphylactic reaction
1%
Diabetic ketoacidosis
1%
Hepatitis cholestatic
1%
Infection
1%
Glomerulonephritis
1%
Arterial thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Nivo + Chemo (PTX QW + AC Q3W) / Nivo + ET
Arm A: Nivo + Chemo (PTX QW + AC Q2W) / Nivo + ET
Arm B: Nivo Placebo + Chemo (PTX QW + AC Q3W) / ET
Arm B: Nivo Placebo + Chemo (PTX QW + AC Q2W) / ET
Trial Design
3Treatment groups
Experimental Treatment
Group I: Before and After SurgeryExperimental Treatment3 Interventions
VB-111 will be administered intravenously at a pre-determined dose at 14-28 days prior to surgery.
Upon recovering from surgery (within 28-35 days after surgery), participants will receive intravenous VB-111 every 6 weeks. Participants evidencing disease progression may initiate bevacizumab at a pre-determined dose as needed for supportive care and will continue with VB-111 infusions every 6 weeks until tumor growth is evidenced a two consecutive time points.
Group II: After Surgery Standard of CareExperimental Treatment2 Interventions
Placebo (IV solution with no medicine) will be administered intravenously at a pre-determined dose at 14-28 days prior to surgery.
Upon recovery from surgery, participants will receive standard of care treatment every 6 weeks until tumor growth is evidenced a two consecutive time points.
Group III: After SurgeryExperimental Treatment4 Interventions
Placebo (IV solution with no medicine) will be administered intravenously at a pre-determined dose at 14-28 days prior to surgery.
Upon recovering from surgery (within 28-35 days after surgery), participants will receive intravenous VB-111 every 6 weeks. Participants evidencing disease progression may initiate bevacizumab at a pre-determined dose as needed for supportive care and will continue with VB-111 infusions every 6 weeks until tumor growth is evidenced a two consecutive time points.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Surgery
2000
Completed Phase 3
~2550
Bevacizumab
2013
Completed Phase 4
~5280
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,933 Total Patients Enrolled
23 Trials studying Glioblastoma
1,011 Patients Enrolled for Glioblastoma
Vascular Biogenics Ltd. operating as VBL TherapeuticsIndustry Sponsor
11 Previous Clinical Trials
1,666 Total Patients Enrolled
2 Trials studying Glioblastoma
327 Patients Enrolled for Glioblastoma
Patrick Wen, MDPrincipal InvestigatorDana-Farber Cancer Institute
10 Previous Clinical Trials
387 Total Patients Enrolled
6 Trials studying Glioblastoma
266 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- It's been over 28 days since my last surgery or 7 days since my last biopsy.I have had focused radiation therapy before.It has been over 42 days since my last cancer treatment.I have a condition where abnormal blood vessels grow in my eyes.I am expected to undergo surgery unrelated to my brain tumor treatment.My cancer has spread to the lining of my brain or outside the brain.My disease can be surgically removed if it gets worse.I will use birth control during and up to 4 months after the trial.I have been diagnosed with a Grade IV brain tumor (glioblastoma or gliosarcoma).I am mostly able to take care of myself.I will use birth control during and up to 4 months after the trial.My tumor is mainly in my brainstem or spinal cord.It's been over 12 weeks since my last radiotherapy, or I have confirmed tumor growth since then.I have previously received treatments targeting blood vessel growth in cancer.I have a second cancer, but it's not one of the exceptions or has been inactive for over 2 years.I haven't had major blood vessel problems like aneurysms or clots in the last 6 months.My blood, liver, and kidney tests are within normal ranges.I have not tested positive for HIV, HBV, or HCV in the last 6 months, or I have evidence of past HBV exposure without active infection.I have a diagnosed liver disease.My brain cancer has worsened for the first or second time after initial treatment.It has been over 42 days since my last nitrosureas treatment.I have recovered from major side effects of my previous cancer treatment, except for hair loss and low lymphocyte count.My blood, liver, and kidney functions are within normal ranges.I am 18 years old or older.I have not had a brain abscess in the last 6 months.My brain cancer has worsened for the first or second time after initial treatment.I haven't had serious heart problems in the last 6 months.I have not had any active bleeding in my stomach or intestines in the last 6 months.My kidney function is within normal limits or moderately reduced.I have not coughed up a noticeable amount of blood in the last 6 months.I have previously been treated with the drug VB-111.My tumor is 4cm or smaller in its longest dimension.I have had a significant brain bleed.My blood pressure is higher than 150/100 mmHg.I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.I have not had a stroke or mini-stroke in the last 6 months.It has been over 23 days since my last chemotherapy session.I am taking 2mg or less of dexamethasone daily and have been on a stable or decreasing dose for at least a week.I have had minor surgery or a device placed for treatment within the last week.I have had a severe blood clot in the past.I have had a gastrointestinal perforation or abscess in the past.I do not have a history of bleeding disorders that could increase my risk of bleeding.I am currently using, or have recently used, high doses of aspirin or clopidogrel.I am taking 2mg or less of dexamethasone daily and have been on a stable or decreasing dose for the last week.I am not on any medication that could affect the study, except for low-dose steroids.My tumor is 4cm or smaller in its longest dimension.It's been over a month since my last surgery, weeks since any cancer treatment, and I haven't started new experimental drugs.I am postmenopausal or cannot have children due to surgery.I have recovered from major side effects of my previous cancer treatment, except for hair loss and low lymphocyte count.I have not had major surgery or significant injury within the last 28 days.I have been diagnosed with a Grade IV brain tumor (glioblastoma or gliosarcoma).My disease can be surgically removed if it gets worse.I have a serious wound or bone fracture that is not healing.
Research Study Groups:
This trial has the following groups:- Group 1: Before and After Surgery
- Group 2: After Surgery Standard of Care
- Group 3: After Surgery
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals still allowed to join this experiment?
"Affirmative. The clinicaltrials.gov page shows that this research study, which was first posted on August 1st 2020, is open for enrolment. 45 patients are required from two medical facilities in order to complete the trial's objectives."
Answered by AI
How many participants is the trial accommodating?
"Affirmative. Clinicaltrials.gov data indicates that this clinical trial has been actively recruiting since it was first posted on August 1st 2020, with a last update occurring on June 6th 2022. 45 participants are required from two separate sites for the study to commence."
Answered by AI
Is surgical intervention permissible under the Food and Drug Administration's guidelines?
"The team at Power rated surgery's safety as a 2, taking into account that it is in Phase 2. This implies some evidence for its security but none to support its efficacy."
Answered by AI
Has there been any empirical research conducted on the efficacy of Surgery?
"Presently, Surgery is being investigated in 357 active medical trials with 90 of them currently at Phase 3. The majority are located in Taibei, Taiwan but there are a total of 17112 sites researching this procedure."
Answered by AI
What medical issues are commonly addressed through surgical procedures?
"Surgery is a viable option for patients with recurrent platinum-sensitive primary peritoneal cancer, malignant neoplasms and stage IV epithelial ovarian cancers following initial resection."
Answered by AI
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