rQNestin for Brain Tumor

Brigham and Women's Hospital, Boston, MA
Brain Tumor+13 More ConditionsrQNestin - Drug
Eligibility
18+
All Sexes

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

1 of 3
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

1 of 3

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
This histogram enumerates side effects from a completed 2016 Phase 2 trial (NCT02004262) in the Pooled Cohort: Cy/GVAX + CRS-207 ARM group. Side effects include: Vaccination site erythema with 82%, Chills with 63%, Vaccination site pain with 56%, Vaccination site induration with 56%, Vaccination site oedema with 54%.

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.

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
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.