Malignant GliomaPhase 1NCT03043391
Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children
A Phase 1 study testing Polio/Rhinovirus Recombinant (PVSRIPO) in people with Malignant Glioma and Anaplastic Astrocytoma, run by Istari Oncology, Inc. at 1 site in United States.
Trial summary
The purpose of the study is to confirm the safety of the selected dose and potential toxicity of oncolytic poliovirus (PV) immunotherapy with PVSRIPO for pediatric patients with recurrent WHO grade III or IV malignant glioma, but evidence for efficacy will also be sought. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Malignant Glioma, Anaplastic Astrocytoma, Anaplastic Oligoastrocytoma
- What is being tested?
- Polio/Rhinovirus Recombinant (PVSRIPO)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2017to 23 Mar 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients must have a recurrent supratentorial WHO Grade III malignant glioma (anaplastic astrocytoma, anaplastic oligoastrocytoma, anaplastic oligodendroglioma, anaplastic pleomorphic xanthoastrocytoma, ependymoma) or WHO Grade IV malignant glioma, medulloblastoma, or atypical teratoid/rhabdoid tumor (ATRT) based on imaging studies with measurable disease (≥ 1 cm and ≤ 5.5 cm). The prior histopathology must be consistent with a World Health Organization (WHO) Grade III or IV malignant tumor confirmed by the study pathologist, Roger McLendon, or his designee.
- There is no standard of care treatment for children with Grade III/IV gliomas; however, patients must have received some form of definitive treatment, i.e., standard therapy with known clinical benefit, for their initial diagnosis prior to their recurrence/progression. Definitive treatment includes maximal safe resection (if possible) and radiation therapy with or without chemotherapy. (Please note that patients who are unable to receive radiation therapy due to genetic disorders that put them at significant risk for radiation-induced secondary malignancies (i.e., Gorlin's syndrome or NF1 mutation) are still eligible to participate).
- Due to the potential implications of the treatment on the developing CNS, all patients must be ≥ 12 years of age and ≤ 21 years of age at the time of entry into the study.
- The patient must have a Lansky or Karnofsky Performance Score (KPS) of ≥ 70% at the time of entry.
- Laboratory Studies:
- Platelet count ≥ 125,000 per microliter prior to biopsy. Platelets ≥ 100,000 per microliter prior to infusion;
Show all 16Show fewer
- Prothrombin and Activated Partial Thromboplastin Times ≤ 1.2 x upper limit of normal (ULN) prior to biopsy;
- Positive serum anti-poliovirus titer ≥ 1:8 prior to biopsy;
- Creatinine ≤ 1.2 x ULN prior to biopsy;
- Total bilirubin, AST, ALT, alkaline phosphatase ≤ 2.5 x ULN prior to biopsy;
- Neutrophil count ≥ 1000 per microliter prior to biopsy;
- Hemoglobin ≥ 9 gm/dl prior to biopsy (can be transfused).
- The patient must have received a boost immunization with trivalent inactivated IPOL™ (Sanofi-Pasteur) ≥ 1 week prior to administration of the study agent.
- At the time of biopsy, prior to administration of virus, the presence of recurrent tumor must be confirmed by histopathological analysis.
- A signed informed consent form approved by the Duke University Institutional Review Board (IRB) will be required for patient enrollment into the study. Patients (if 18 years old) or their parent(s) or guardian(s) must be able to read and understand the informed consent document and must sign the informed consent indicating that they are aware of the investigational nature of this study. All children will have to provide assent to the study.
- Able to undergo brain MRI with and without contrast without requiring general anesthesia.
Who cannot join
- Pregnant or breast-feeding. Female patients of child-bearing potential or female sexual partners (who are of child-bearing potential) of male patients must use at least one of the following methods of medically acceptable contraceptives: approved hormonal contraceptives (such as birth control pills, patches, implants or infusions), an intrauterine device (IUD), or a barrier method of contraception (such as a condom or diaphragm) used ith spermicide. Because all patients are required to have a boost immunization of trivalent inactivated IPOL™, there should be no risk of transmission of a mother to her fetus after receiving intracranial PVSRIPO. As such, patients who become pregnant after receiving PVSRIPO will continue to be monitored in the same manner, i.e. per protocol, unless the assessment is contra-indicated during pregnancy. Partners who become pregnant will sign a Pregnant Partner Information Form and information regarding the pregnancy and its outcome may be collected.
- Patients with an impending, life-threatening cerebral herniation syndrome, based on the assessment of the study neurosurgeon.
- Patients with an active infection requiring intravenous treatment or having an unexplained febrile illness (Tmax > 99.5°F).
- Patients with known immunosuppressive disease or known human immunodeficiency virus infection.
- Patients with unstable or severe intercurrent medical conditions such as severe heart (New York Heart Association Class 3 or 4) or lung (FEV1 < 50%) disease, uncontrolled diabetes mellitus.
- Patients with allergy to human serum albumin.
Show all 18Show fewer
- Current or history of anaphylactic reaction to gadolinium.
- A history of neurological complications due to past PV infection would imply previous virus replication in the CNS. Based on animal studies, previous exposure to poliovirus administered intracerebrally can reduce subsequent virus replication in the CNS.
- Patients who have not recovered from the toxic effects of prior chemo- and/or radiation therapy. Guidelines for this recovery period are dependent upon the specific therapeutic agent being used:
- Patients who are less than 12 weeks from radiation therapy, unless progressive disease outside of the radiation field or 2 consecutive scans with disease progression or histopathologic confirmation of recurrent tumor.
- Patients who have received chemotherapy or bevacizumab ≤ 4 weeks [except for nitrosourea (6 weeks) or metronomic dosed chemotherapy such as daily etoposide or cyclophosphamide (1 week)] prior to starting the study drug unless patients have recovered from side effects of such therapy.
- Patients who have received immunotherapy ≤ 4 weeks prior to starting the study drug unless patients have recovered from side effects of such therapy.
- Patients with neoplastic lesions in the brainstem, cerebellum, spinal cord, intraventricular tumors, pituitary tumors, leptomeningeal disease, or other locations at the discretion of the treating neurosurgeon.
- Patients with a diagnosis of agammaglobulinemia, that is:
- Undetectable anti-tetanus toxoid IgG
- Known history of agammaglobulinemia
- Patients who are on dexamethasone receiving > 4 mg/day in the two weeks prior to admission for intra-cerebral delivery of PVSRIPO or who demonstrate worsening steroid myopathy.
- Patients with prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Phase Ib Study of Oncolytic Polio/Rhinovirus Recombinant Against Recurrent Malignant Glioma in Children
The purpose of the study is to confirm the safety of the selected dose and potential toxicity of oncolytic poliovirus (PV) immunotherapy with PVSRIPO for pediatric patients with recurrent WHO grade III or IV malignant glioma, but evidence for efficacy will also be sought. The primary objective is to confirm the safety of the selected dose of PVSRIPO when delivered intracerebrally by convection-enhanced delivery (CED) in children with recurrent WHO Grade III malignant glioma (anaplastic astrocytoma, anaplastic oligoastrocytoma, anaplastic oligodendroglioma, anaplastic pleomorphic xanthoastrocytoma) or WHO Grade IV malignant glioma (glioblastoma, gliosarcoma). A secondary objective is to estimate overall survival (OS) in this population.
Read the detailed description
PVSRIPO will be delivered intratumorally by CED using an intracerebral catheter placed within the enhancing portion of the tumor. The population group are patients with recurrent WHO grade III or IV malignant glioma who are aged 12 through 21 years old. After a single dose of PVSRIPO, subjects will return for periodic visits to monitor tumor status, adverse events, and changes in blood immune profiles. A maximum of 12 pediatric patients will be treated with PVSRIPO, and then carefully monitored for safety for at least a year after treatment.
- Conditions
- Malignant Glioma, Anaplastic Astrocytoma, Anaplastic Oligoastrocytoma, Anaplastic Oligodendroglioma, Glioblastoma, Gliosarcoma
- Being tested
- Polio/Rhinovirus Recombinant (PVSRIPO)
- Keywords
- Pediatric Malignant Glioma, PVSRIPO, Pro00071228, Eric Thompson, Darell Bigner, Oncolytic Poliovirus, Daniel Landi
- Medical subject headings
- Glioma, Astrocytoma, Oligodendroglioma, Glioblastoma, Gliosarcoma, Medulloblastoma, Ependymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polio/Rhinovirus Recombinant (PVSRIPO)Biological
PVSRIPO will be delivered intratumorally by convection-enhanced delivery (CED) using an intracerebral catheter placed within the enhancing portion of the tumor. A stereotactic biopsy will be performed prior to virus administration. Immediately following the stereotactically-guided tumor biopsy, a catheter will be implanted in the operating room at a site the same or different from that used for the biopsy using sterile techniques under general anesthesia. The entire volume of PVSRIPO to be delivered will be pre-loaded into a syringe by the investigational pharmacist and connected to the catheter under sterile conditions in the Pediatric Intensive Care Unit (PICU) just prior to beginning of infusion.
| Study group | Role | What they receive |
|---|---|---|
| Polio/Rhinovirus Recombinant (PVSRIPO) | Experimental | PVSRIPO is an altered form of the live polio vaccine. It was produced by removing a piece of the virus and replacing it with a piece from a common cold virus. This was done to make sure PVSRIPO cannot cause polio even when injected into the brain. Receives: Biological: Polio/Rhinovirus Recombinant (PVSRIPO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Unacceptable Toxicity
Percentage of participants with unacceptable toxicity during the 14-day period post-PVSRIPO treatment
Measured: 14 days after treatment with PVSRIPO
Percentage of Participants Requiring Low-dose Bevacizumab or Steroid
The percentage of participants requiring low-dose bevcizumab or steroid due to an inflammatory reaction secondary to an immune response to lerapolturev treatment
Measured: 1 year
Secondary outcomes (1)
Overall Survival
Estimation of overall survival calculated at the time between lerapolturev infusion and death or last follow-up if the participant is alive using the Kaplan-Meier method
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study start7 Nov 2017
- Primary completion23 Mar 2022
- Study completion23 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Malignant GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase Ib study to evaluate feasibility, safety, and preliminary evidence of efficacy of the optimal adult dose in a pediatric population
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istari Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Solving Kids' Cancer, The Andrew McDonough B+ Foundation, Duke University
- Responsible party
- Sponsor
- Investigators
- Darell Bigner, MD, PhD, Study director, Istari Oncology, Inc.Daniel Landi, MD, Principal investigator, Duke UniversityEric Thompson, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043391
- Sponsor's protocol ID
- Pro00071228
- Status last verified
- Jun 2022
- First submitted
- 2 Feb 2017
- Last updated
- 8 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barkley A, Butler E, Park C, Friedman A, Landi D, Ashley DM, Bigner D, Bernstock JD, Friedman GK, Johnston JM, Thompson EM. The safety and accuracy of intratumoral catheter placement to infuse viral immunotherapies in children with malignant brain tumors: a multi-institutional study. J Neurosurg Pediatr. 2024 Jan 12;33(4):359-366. doi: 10.3171/2023.12.PEDS23404. Print 2024 Apr 1.
PubMed 38215438Thompson EM, Landi D, Brown MC, Friedman HS, McLendon R, Herndon JE 2nd, Buckley E, Bolognesi DP, Lipp E, Schroeder K, Becher OJ, Friedman AH, McKay Z, Walter A, Threatt S, Jaggers D, Desjardins A, Gromeier M, Bigner DD, Ashley DM. Recombinant polio-rhinovirus immunotherapy for recurrent paediatric high-grade glioma: a phase 1b trial. Lancet Child Adolesc Health. 2023 Jul;7(7):471-478. doi: 10.1016/S2352-4642(23)00031-7. Epub 2023 Mar 30.
PubMed 37004712
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Study of Oncolytic Polio/Rhinovirus Recombinant Against Recurrent Malignant Glioma in Children
- ClinicalTrials.gov ID
- NCT03043391
- Acronym / sponsor ID
- Pro00071228
- Conditions
- Malignant Glioma, Anaplastic Astrocytoma, Anaplastic Oligoastrocytoma, Anaplastic Oligodendroglioma, Glioblastoma, Gliosarcoma
- Keywords
- Pediatric Malignant Glioma, PVSRIPO, Pro00071228, Eric Thompson, Darell Bigner, Oncolytic Poliovirus, Daniel Landi
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Istari Oncology, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Solving Kids' Cancer, The Andrew McDonough B+ Foundation, Duke University
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 23 Mar 2022 (actual)
- Study completion
- 23 Mar 2022 (actual)
- First posted
- 6 Feb 2017 (estimated)
- Results
- Posted 8 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to confirm the safety of the selected dose and potential toxicity of oncolytic poliovirus (PV) immunotherapy with PVSRIPO for pediatric patients with recurrent WHO grade III or IV malignant glioma, but evidence for efficacy will also be sought. The primary objective is to confirm the safety of the selected dose of PVSRIPO when delivered intracerebrally by convection-enhanced delivery (CED) in children with recurrent WHO Grade III malignant glioma (anaplastic astrocytoma, anaplastic oligoastrocytoma, anaplastic oligodendroglioma, anaplastic pleomorphic xanthoastrocytoma) or WHO Grade IV malignant glioma (glioblastoma, gliosarcoma). A secondary objective is to estimate overall survival (OS) in this population.
Detailed description
PVSRIPO will be delivered intratumorally by CED using an intracerebral catheter placed within the enhancing portion of the tumor. The population group are patients with recurrent WHO grade III or IV malignant glioma who are aged 12 through 21 years old. After a single dose of PVSRIPO, subjects will return for periodic visits to monitor tumor status, adverse events, and changes in blood immune profiles. A maximum of 12 pediatric patients will be treated with PVSRIPO, and then carefully monitored for safety for at least a year after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase Ib study to evaluate feasibility, safety, and preliminary evidence of efficacy of the optimal adult dose in a pediatric population
| Arm | Type | Receives |
|---|---|---|
| Polio/Rhinovirus Recombinant (PVSRIPO) | Experimental | Biological: Polio/Rhinovirus Recombinant (PVSRIPO)PVSRIPO is an altered form of the live polio vaccine. It was produced by removing a piece of the virus and replacing it with a piece from a common cold virus. This was done to make sure PVSRIPO cannot cause polio even when injected into the brain. |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- Patients must have a recurrent supratentorial WHO Grade III malignant glioma (anaplastic astrocytoma, anaplastic oligoastrocytoma, anaplastic oligodendroglioma, anaplastic pleomorphic xanthoastrocytoma, ependymoma) or WHO Grade IV malignant glioma, medulloblastoma, or atypical teratoid/rhabdoid tumor (ATRT) based on imaging studies with measurable disease (≥ 1 cm and ≤ 5.5 cm). The prior histopathology must be consistent with a World Health Organization (WHO) Grade III or IV malignant tumor confirmed by the study pathologist, Roger McLendon, or his designee.
- There is no standard of care treatment for children with Grade III/IV gliomas; however, patients must have received some form of definitive treatment, i.e., standard therapy with known clinical benefit, for their initial diagnosis prior to their recurrence/progression. Definitive treatment includes maximal safe resection (if possible) and radiation therapy with or without chemotherapy. (Please note that patients who are unable to receive radiation therapy due to genetic disorders that put them at significant risk for radiation-induced secondary malignancies (i.e., Gorlin's syndrome or NF1 mutation) are still eligible to participate).
- Due to the potential implications of the treatment on the developing CNS, all patients must be ≥ 12 years of age and ≤ 21 years of age at the time of entry into the study.
- The patient must have a Lansky or Karnofsky Performance Score (KPS) of ≥ 70% at the time of entry.
- Laboratory Studies:
Key exclusion criteria (18 listed)
- Pregnant or breast-feeding. Female patients of child-bearing potential or female sexual partners (who are of child-bearing potential) of male patients must use at least one of the following methods of medically acceptable contraceptives: approved hormonal contraceptives (such as birth control pills, patches, implants or infusions), an intrauterine device (IUD), or a barrier method of contraception (such as a condom or diaphragm) used ith spermicide. Because all patients are required to have a boost immunization of trivalent inactivated IPOL™, there should be no risk of transmission of a mother to her fetus after receiving intracranial PVSRIPO. As such, patients who become pregnant after receiving PVSRIPO will continue to be monitored in the same manner, i.e. per protocol, unless the assessment is contra-indicated during pregnancy. Partners who become pregnant will sign a Pregnant Partner Information Form and information regarding the pregnancy and its outcome may be collected.
- Patients with an impending, life-threatening cerebral herniation syndrome, based on the assessment of the study neurosurgeon.
- Patients with an active infection requiring intravenous treatment or having an unexplained febrile illness (Tmax > 99.5°F).
- Patients with known immunosuppressive disease or known human immunodeficiency virus infection.
- Patients with unstable or severe intercurrent medical conditions such as severe heart (New York Heart Association Class 3 or 4) or lung (FEV1 < 50%) disease, uncontrolled diabetes mellitus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polio/Rhinovirus Recombinant (PVSRIPO)PVSRIPO will be delivered intratumorally by convection-enhanced delivery (CED) using an intracerebral catheter placed within the enhancing portion of the tumor. A stereotactic biopsy will be performed prior to virus administration. Immediately following the stereotactically-guided tumor biopsy, a catheter will be implanted in the operating room at a site the same or different from that used for the biopsy using sterile techniques under general anesthesia. The entire volume of PVSRIPO to be delivered will be pre-loaded into a syringe by the investigational pharmacist and connected to the catheter under sterile conditions in the Pediatric Intensive Care Unit (PICU) just prior to beginning of infusion. | Biological | Polio/Rhinovirus Recombinant (PVSRIPO) |
Primary outcome
Percentage of Participants With Unacceptable Toxicity
Time frame: 14 days after treatment with PVSRIPO
Percentage of participants with unacceptable toxicity during the 14-day period post-PVSRIPO treatment
Percentage of Participants Requiring Low-dose Bevacizumab or Steroid
Time frame: 1 year
The percentage of participants requiring low-dose bevcizumab or steroid due to an inflammatory reaction secondary to an immune response to lerapolturev treatment
1 secondary outcome
Overall Survival
Time frame: up to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38215438Barkley A, Butler E, Park C, Friedman A, Landi D, Ashley DM, Bigner D, Bernstock JD, Friedman GK, Johnston JM, Thompson EM. The safety and accuracy of intratumoral catheter placement to infuse viral immunotherapies in children with malignant brain tumors: a multi-institutional study. J Neurosurg Pediatr. 2024 Jan 12;33(4):359-366. doi: 10.3171/2023.12.PEDS23404. Print 2024 Apr 1.
- Derived from this study: PubMed 37004712Thompson EM, Landi D, Brown MC, Friedman HS, McLendon R, Herndon JE 2nd, Buckley E, Bolognesi DP, Lipp E, Schroeder K, Becher OJ, Friedman AH, McKay Z, Walter A, Threatt S, Jaggers D, Desjardins A, Gromeier M, Bigner DD, Ashley DM. Recombinant polio-rhinovirus immunotherapy for recurrent paediatric high-grade glioma: a phase 1b trial. Lancet Child Adolesc Health. 2023 Jul;7(7):471-478. doi: 10.1016/S2352-4642(23)00031-7. Epub 2023 Mar 30.
- The Preston Robert Tisch Brain Tumor Center at DukeLink provided by the sponsor.
- The Preston Robert Tisch Brain Tumor Center at Duke Pediatric ProgramLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Malignant Glioma
Active, not recruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1
Locoregional Administration of Genetically Engineered Cells (EGFR/IL13Rα2 Pool-CAR T Cells) for the Treatment of Recurrent or Progressive High-Grade Gliomas
Recurrent Astrocytoma, IDH-Mutant, Grade 4, Recurrent Glioblastoma, IDH-Wildtype
RecruitingPhase 2
ACT001 for the Treatment of Diffuse Intrinsic Pontine Gliomas and H3K27-altered High Grade Gliomas
Diffuse Intrinsic Pontine Gliomas (DIPG), Progressive DIPG
RecruitingPhase 1/2
Study of an AAV Mediated Dual-Payload Gene Therapy in Patients With High Grade Glioma
Glioblastoma (GBM), High Grade Gliomas
RecruitingPhase 1
Intracranial Genetically Modified Immune Cells (TGFβR2KO/IL13Rα2 CAR T-Cells) for the Treatment of Recurrent or Progressive Glioblastoma or Grade 3 or 4 IDH-Mutant Astrocytoma
Recurrent Astrocytoma, IDH-Mutant, Grade 3, Recurrent Astrocytoma, IDH-Mutant, Grade 4
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darell Bigner, MD, PhD study director
Istari Oncology, Inc.
Daniel Landi, MD principal investigator
Duke University
Eric Thompson, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Polio/Rhinovirus Recombinant (PVSRIPO) in people with Malignant Glioma and Anaplastic Astrocytoma, run by Istari Oncology, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Unacceptable Toxicity (time frame: 14 days after treatment with PVSRIPO). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03043391, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.