GlioblastomaPhase 1NCT03714334
DNX-2440 Oncolytic Adenovirus for Recurrent Glioblastoma
A Phase 1 study testing DNX-2440 injection in people with Glioblastoma and Glioblastoma, Adult, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial summary
Patients with first or second recurrence of GBM will be treated with stereotactic injection of the oncolytic virus DNX-2440. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Glioblastoma, Adult
- What is being tested?
- DNX-2440 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSpain
- Study dates
- 16 Oct 2018to 5 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients willing and able to give informed consent.
- Patient must be, in the investigator opinion, able to comply with all the protocol procedures.
- Age ≥18
- Negative pregnant test in case of fertile women*
- Patients with diagnosis of first or second recurrence of Glioblastoma or any of its variants (Gliosarcoma, Giant cell Glioblastoma or epithelioid Glioblastoma) based on histopathology at first diagnosis and clinical and radiological follow-up. Recurrences within the radiation field will be considered if there is confirmed growing of the lesion in two MRI, or occur at least 12 weeks after completion of radiotherapy, or if there is clear histopathological confirmation of tumor recurrence. This limitation does not apply for recurrences occurring outside the radiation field
- A single measurable lesion bigger than 10 mm in two perpendicular diameters, considered appropriate for safe stereotactic biopsy and virus injection without entering the ventricle.
Show all 11Show fewer
- No other chemotherapy or immunotherapy for the tumor in the four weeks previous to the inclusion
- Karnofsky Performance Status ≥ 70 before inclusion.
- Must have adequate renal, bone marrow and liver function.
- Steroid-free or requiring stable doses of a maximum of 2mg dexamethasone /day or equivalent in the previous two weeks.
- A woman is considered fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
Who cannot join
- Severe infections or intercurrent medical conditions including, but not limited to, severe renal, hepatic, heart or bone marrow failure, that, on investigator´s criteria, do not allow the inclusion. Patients must be afebrile at baseline [i.e., < 38 degrees (C)].
- Patients with an enhancing lesion bigger than 25cc, including necrotic tumor portions encircled inside the enhancing areas.
- Subjects with immunodeficiency, autoimmune conditions or active hepatitis.
- Any medical or psychological condition that might interfere with the subject's ability to participate or give informed consent or would compromise the patient's ability to tolerate therapy or any disease that will obscure toxicity or dangerously alter drug metabolism.
- Current diagnosis of other cancer except in situ cervical cancer, basal or squamous cell carcinoma of the skin. Patients with a history of another cancer remain eligible if they are cancer free for at least three years.
- Pregnant or breast-feeding females will be excluded, due to the risk for the fetal development of a recombinant virus containing genes related to cellular growth and differentiation.
Show all 17Show fewer
- Severe bone marrow hypoplasia.
- AST and/or ALT > 4 times over upper normal laboratory level
- Neutrophils < 1.5 x 109/L
- Thrombocytes ≤ 100 x 109/L
- Hemoglobin < 9g/dl
- Multiple lesions, extensive ill-defined diffuse lesions, or lesions considered risky for stereotactic injection of virus, like periventricular lesions.
- Patients with Li-Fraumeni Syndrome or with a known germ line deficit in the retinoblastoma gene or its related pathways.
- Biologic/immunotherapy (e.g., IL-2, IL-12, interferon) within 4 weeks of DNX-2440 administration.
- Vaccination of any kind within 4 weeks prior to DNX-2440 administration.
- Inability to undergo MRI examination for any reason.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Trial of DNX-2440 Oncolytic Adenovirus in Patients With Recurrent Glioblastoma
Patients with first or second recurrence of GBM will be treated with stereotactic injection of the oncolytic virus DNX-2440.
Read the detailed description
After inclusion in the trial, stereotactic biopsy will be performed. In the same surgery, the experimental agent will be injected also by stereotactic system, in a different part of the lesion, in a region considered viable tumor, using a cannula especially designed for virus injection.
Follow-up will include clinical visits and MRI No other treatment for the tumor will be used until progression is documented. iRANO criteria and volumetric measurement of the tumor will be used.
Any further treatment after progression will be at the criteria of the treating physician
- Conditions
- Glioblastoma, Glioblastoma, Adult
- Being tested
- DNX-2440 injection
- Keywords
- Recurrent Glioblastoma, oncolytic virus, immunotherapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNX-2440 injectionDrug
DNX-2440 virus will be injected stereotactically
| Study group | Role | What they receive |
|---|---|---|
| DNX-2440 injection | Experimental | all the patients included will be treated with the experimental agent Receives: Drug: DNX-2440 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events after brain administration of DNX-2440.
Incidence and severity of adverse effects will be collected and described
Measured: 8 weeks
Secondary outcomes (3)
Overall Survival at 12 months (OS12)
rate of patients surviving at 12 months since injection
Measured: 12 months
Overall survival
Survival along the whole interval of follow-up
Measured: 25 months
Overall response rate (ORR)
total of patients with Complete responses plus partial responses
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start16 Oct 2018
- Primary completion5 Apr 2023
- Study completion5 Apr 2023
Why it stopped: Break of stock
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies 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
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- DNAtrix, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714334
- Sponsor's protocol ID
- D2440GBM1
- Status last verified
- Apr 2023
- First submitted
- 16 Oct 2018
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of DNX-2440 Oncolytic Adenovirus in Patients With Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT03714334
- Acronym / sponsor ID
- D2440GBM1
- Conditions
- Glioblastoma, Glioblastoma, Adult
- Keywords
- Recurrent Glioblastoma, oncolytic virus, immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Break of stock
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Collaborators
- DNAtrix, Inc.
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 5 Apr 2023 (actual)
- Study completion
- 5 Apr 2023 (actual)
- First posted
- 22 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with first or second recurrence of GBM will be treated with stereotactic injection of the oncolytic virus DNX-2440.
Detailed description
After inclusion in the trial, stereotactic biopsy will be performed. In the same surgery, the experimental agent will be injected also by stereotactic system, in a different part of the lesion, in a region considered viable tumor, using a cannula especially designed for virus injection.
Follow-up will include clinical visits and MRI No other treatment for the tumor will be used until progression is documented. iRANO criteria and volumetric measurement of the tumor will be used.
Any further treatment after progression will be at the criteria of the treating physician
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DNX-2440 injection | Experimental | Drug: DNX-2440 injectionall the patients included will be treated with the experimental agent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients willing and able to give informed consent.
- Patient must be, in the investigator opinion, able to comply with all the protocol procedures.
- Age ≥18
- Negative pregnant test in case of fertile women*
- Patients with diagnosis of first or second recurrence of Glioblastoma or any of its variants (Gliosarcoma, Giant cell Glioblastoma or epithelioid Glioblastoma) based on histopathology at first diagnosis and clinical and radiological follow-up. Recurrences within the radiation field will be considered if there is confirmed growing of the lesion in two MRI, or occur at least 12 weeks after completion of radiotherapy, or if there is clear histopathological confirmation of tumor recurrence. This limitation does not apply for recurrences occurring outside the radiation field
Key exclusion criteria (17 listed)
- Severe infections or intercurrent medical conditions including, but not limited to, severe renal, hepatic, heart or bone marrow failure, that, on investigator´s criteria, do not allow the inclusion. Patients must be afebrile at baseline [i.e., < 38 degrees (C)].
- Patients with an enhancing lesion bigger than 25cc, including necrotic tumor portions encircled inside the enhancing areas.
- Subjects with immunodeficiency, autoimmune conditions or active hepatitis.
- Any medical or psychological condition that might interfere with the subject's ability to participate or give informed consent or would compromise the patient's ability to tolerate therapy or any disease that will obscure toxicity or dangerously alter drug metabolism.
- Current diagnosis of other cancer except in situ cervical cancer, basal or squamous cell carcinoma of the skin. Patients with a history of another cancer remain eligible if they are cancer free for at least three years.
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 |
|---|---|---|
| DNX-2440 injectionDNX-2440 virus will be injected stereotactically | Drug | DNX-2440 injection |
Primary outcome
Incidence of Treatment-Emergent Adverse Events after brain administration of DNX-2440.
Time frame: 8 weeks
Incidence and severity of adverse effects will be collected and described
3 secondary outcomes
Overall Survival at 12 months (OS12)
Time frame: 12 months
Overall survival
Time frame: 25 months
Overall response rate (ORR)
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Break of stock). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
Related trials for Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
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.
The record lists no contact. Use the official record to reach the sponsor.
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 DNX-2440 injection in people with Glioblastoma and Glioblastoma, Adult, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
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 11 inclusion and 17 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: stopped early, as of the sponsor's last update on 7 Apr 2023. 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 Spain. 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?
The study was stopped early (reason given: Break of stock). Results are not available in the source record.
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?
Incidence of Treatment-Emergent Adverse Events after brain administration of DNX-2440. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.