Study Summary
This trial is testing the safety of a new virus-based drug for brain tumors. If it is safe, they will also test what dose is most effective.
Eligible Conditions
- Brain Tumor
- Oligodendroglioma
- Pylocytic/Pylomyxoid Astrocytoma
- Glioblastoma
- Astrocytoma
- Oligoastrocytoma
- Ependymoma
- Ganglioglioma
- Anaplastic Oligodendroglioma
- Cancer Brain Metastases
Treatment Effectiveness
Phase-Based Effectiveness
Phase 1
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: Evaluated every 2 months for 1 year
Year 1
MRI Changes in Flow
MRI Changes in Permeability
MRI Changes in Volume
Day 56
HSV1 Antibody Response
HSV1 Viremia
Viral Shedding in Saliva
Minimum of 21 Days
Maximum Tolerated Dose
Trial Safety
Phase-Based Safety
Side Effects for
Pooled Cohort: Cy/GVAX + CRS-207
82%Vaccination site erythema
63%Chills
56%Vaccination site pain
56%Vaccination site induration
54%Vaccination site oedema
54%Pyrexia
53%Fatigue
52%Vaccination site pruritus
45%Nausea
34%Vomiting
32%Abdominal pain
27%Constipation
27%Vaccination site bruising
26%Decreased appetite
20%Anaemia
19%Back pain
19%Blood alkaline phosphatase increased
19%Headache
19%Hypotension
18%Aspartate aminotransferase increased
16%Oedema peripheral
14%Hyponatraemia
14%Tachycardia
14%Disease progression
13%Diarrhoea
13%Alanine aminotransferase increased
13%Thrombocytopenia
12%Pruritus
11%Weight decreased
11%Hypertension
10%Abdominal distension
10%Insomnia
9%Abdominal pain upper
9%Dehydration
9%Hypoalbuminaemia
9%Erythema
9%Ascites
9%Flatulence
9%Blood bilirubin increased
9%Dyspnoea
9%Pain
7%Hypokalaemia
7%Dizziness
7%Myalgia
7%Lymphocyte count decreased
6%Arthralgia
6%Hypomagnesaemia
6%Hyperglycaemia
6%Gastrooesophageal reflux disease
6%Blood creatinine increased
6%Pulmonary embolism
6%Pain in extremity
6%Hypoxia
6%Hyperkalaemia
6%Vaccination site vesicles
5%Blood sodium decreased
5%Leukocytosis
5%Bile duct obstruction
5%Hypophosphataemia
5%Asthenia
5%Confusional state
5%Deep vein thrombosis
5%Blood albumin decreased
5%Night sweats
5%International normalised ratio increased
4%Abdominal Pain
3%Dry mouth
3%Sinus tachycardia
3%Dry skin
3%Urinary tract infection
3%Upper respiratory tract infection
3%Neuropathy peripheral
2%Anxiety
2%Upper gastrointestinal haemorrhage
2%Cerebrovascular accident
2%Cough
2%Cholangitis
2%Malignant pleural effusion
1%Herpes zoster
1%Superior vena cava syndrome
1%Atrial fibrillation
1%Ileus
1%Lower gastrointestinal haemorrhage
1%Transient ischaemic attack
1%Failure to thrive
1%Acute myocardial infarction
1%Myocardial infarction
1%Musculoskeletal chest pain
1%Sepsis
1%Klebsiella sepsis
1%Hyperbilirubinaemia
1%Renal failure acute
1%Syncope
1%Rash
1%Memory impairment
1%Haemorrhage
1%Gastritis
1%Pneumonia
1%Gastrointestinal haemorrhage
1%Spinal cord compression
1%Hallucination
1%Mental status changes
1%Cerebral haemorrhage
1%Gastrointestinal anastomotic complication
1%Device dislocation
1%Jaundice cholestatic
1%Small intestinal obstruction
1%Death
1%Hip fracture
1%Neutropenia
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
3 Treatment Groups
Arm C- Multiple Dose rQNestin
1 of 3
Arm A- rQNestin
1 of 3
Arm B- rQNestin+CPA
1 of 3
Experimental Treatment
62 Total Participants · 3 Treatment Groups
Primary Treatment: rQNestin · No Placebo Group · Phase 1
Arm C- Multiple Dose rQNestinExperimental Group · 2 Interventions: Stereotactic biopsy, rQNestin · Intervention Types: Procedure, Drug
Arm A- rQNestinExperimental Group · 2 Interventions: Stereotactic biopsy, rQNestin · Intervention Types: Procedure, Drug
Arm B- rQNestin+CPAExperimental Group · 3 Interventions: Cyclophosphamide, Stereotactic biopsy, rQNestin · Intervention Types: Drug, Procedure, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: evaluated every 2 months for 1 year
Who is running the clinical trial?
Candel Therapeutics, Inc.Industry Sponsor
11 Previous Clinical Trials
1,207 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,029 Previous Clinical Trials
755,773 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,552 Previous Clinical Trials
24,612,530 Total Patients Enrolled
E. Antonio Chiocca, MD, PhD5.06 ReviewsPrincipal Investigator - Brigham and Women's Hospital
Dana-Farber Cancer Institute
3 Previous Clinical Trials
103 Total Patients Enrolled
5Patient Review
Dr. Chiocca is an excellent neurosurgeon. We were told my husband had a reoccurrence of tumors, but Dr. Chiocca diagnosed it as scar tissue from looking at the MRI. This saved my husband from having surgery to remove the tumors. We are very happy with the care he received.
Eligibility Criteria
Age 18+ · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:It is not known if rQNestin34.5v.2 and cyclophosphamide can harm an unborn baby.
You have received temozolomide chemotherapy during and after external beam radiotherapy as part of your regular treatment.
References
- Chiocca, E. Antonio, Hiroshi Nakashima, Kazue Kasai, Soledad A. Fernandez, and Michael Oglesbee. 2020. “Preclinical Toxicology of Rqnestin34.5v.2: An Oncolytic Herpes Virus with Transcriptional Regulation of the ICP34.5 Neurovirulence Gene”. Molecular Therapy - Methods & Clinical Development. Elsevier BV. doi:10.1016/j.omtm.2020.03.028.
- Otani, Yoshihiro, Ji Young Yoo, Cole T. Lewis, Samantha Chao, Jessica Swanner, Toshihiko Shimizu, Jin Muk Kang, et al.. 2022. “Notch-induced MDSC Recruitment After Ohsv Virotherapy in CNS Cancer Models Modulates Antitumor Immunotherapy”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-21-2347.
- E. Antonio Chiocca, MD, PhD 2017. "A Study of the Treatment of Recurrent Malignant Glioma With rQNestin34.5v.2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03152318.
Frequently Asked Questions
Has the FDA authorized rQNestin for usage?
"Data on rQNestin's safety and efficacy is limited, thus warranting a score of 1 according to the team at Power." - Anonymous Online Contributor
Unverified Answer
Have there been any other experimental trials involving rQNestin?
"Presently, 816 clinical studies of rQNestin are ongoing. Of those trials, 154 have reached Phase 3 and the majority are located in Philadelphia, PA; however there are 27825 sites globally conducting research with this medication." - Anonymous Online Contributor
Unverified Answer
To what diseases is rQNestin typically administered?
"rQNestin has proven to be a successful therapeutic intervention for multiple sclerosis, mixed-cell type lymphoma, and myelocytic acute leukemia." - Anonymous Online Contributor
Unverified Answer
Is this research effort presently recruiting participants?
"Clinicaltrials.gov confirms that this study is actively in search of participants, with the initial listing posted on July 18th 2017 and most recently edited October 24th 2022." - Anonymous Online Contributor
Unverified Answer
How extensive is the participant population of this clinical experiment?
"Affirmative. Clinicaltrials.gov shows that the medical study, initially listed on 18th July 2017, is currently recruiting patients and requires 62 people at two different sites to partake in this experiment." - Anonymous Online Contributor
Unverified Answer