ChildrenPhase 1/2NCT01844661
Safety and Efficacy of Repeated Infusion of CELYVIR in Children and Adults With Metastatic and Refractory Tumors.
A Phase 1/2 study testing CELYVIR in people with Children and Solid Tumors, run by Hospital Infantil Universitario Niño Jesús, Madrid, Spain at 1 site in Spain.
Trial summary
The investigators will evaluate the safety of weekly infusions (n=6) of CELYVIR in children and adults with metastatic and refractory solid tumors. CELYVIR consists in bone marrow-derived autologous mesenchymal stem cells (MSCs) infected with ICOVIR5, an oncolytic adenovirus. Read more about this study
- Who is it for?
- Ages 6 months to 75 years
- Conditions the study is for
- Children, Solid Tumors, Metastases
- What is being tested?
- CELYVIR
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2013to Jan 2016
- Phase
- Phase 1/2
- 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 6 months to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Children: Up to 18 yrs. Refractory to at least 2 previous therapy lines. Life expectancy more than 6 months. Measurable disease.
- Adults: 18-75 yrs. Refractory to at least 2 previous therapy lines. ECOG (Eastern Cooperative Oncology Group) <2. Measurable disease.
Who cannot join
- Pregnancy.
- Central Nervous System metastasis.
- Experimental therapy during the previous month.
- Chemotherapy less than 3 weeks previous.
- Any organ functionally impaired.
- Concurrent infectious disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Trial of Celyvir in Children and Adults With Metastatic and Refractory Solid Tumors.
The investigators will evaluate the safety of weekly infusions (n=6) of CELYVIR in children and adults with metastatic and refractory solid tumors. CELYVIR consists in bone marrow-derived autologous mesenchymal stem cells (MSCs) infected with ICOVIR5, an oncolytic adenovirus. In addition to data on toxicities the investigators will evaluate clinical response.
- Conditions
- Children, Solid Tumors, Metastases
- Being tested
- CELYVIR
- Keywords
- Mesenchymal stem cells, Oncolytic adenovirus
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CELYVIRBiological
Also called Bone marrow-derived autologous mesenchymal stem cells infected with ICOVIR5, an oncolytic adenovirus.
| Study group | Role | What they receive |
|---|---|---|
| CELYVIR | Experimental | Patients will received weekly (n=6) IV infusion of Celyvir. Receives: Biological: CELYVIR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse effects after intravenous infusions
We will record any sign or symptom that could be related to the infusion of Celyvir.
Measured: 48 hours after each infusion
Secondary outcomes (1)
Clinical outcome
Clinical outcome will be labelled as complete response, partial response, stable disease or disease progression.
Measured: Up to 2 months after the last infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2014
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ChildrenStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Infantil Universitario Niño Jesús, Madrid, Spain
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Manuel Ramírez, MD PhD, Hospital Infantil Universitario Niño Jesús, Madrid, Spain
- Investigators
- Manuel Ramírez, MD PhD, Principal investigator, Hospital Universitario Niño Jesús
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844661
- Sponsor's protocol ID
- EudraCT2008-000364-16
- Status last verified
- Feb 2016
- First submitted
- 29 Apr 2013
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Morales-Molina A, Gambera S, Leo A, Garcia-Castro J. Combination immunotherapy using G-CSF and oncolytic virotherapy reduces tumor growth in osteosarcoma. J Immunother Cancer. 2021 Mar;9(3):e001703. doi: 10.1136/jitc-2020-001703.
PubMed 33737338Ruano D, Lopez-Martin JA, Moreno L, Lassaletta A, Bautista F, Andion M, Hernandez C, Gonzalez-Murillo A, Melen G, Alemany R, Madero L, Garcia-Castro J, Ramirez M. First-in-Human, First-in-Child Trial of Autologous MSCs Carrying the Oncolytic Virus Icovir-5 in Patients with Advanced Tumors. Mol Ther. 2020 Apr 8;28(4):1033-1042. doi: 10.1016/j.ymthe.2020.01.019. Epub 2020 Jan 21.
PubMed 32053771
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Trial of Celyvir in Children and Adults With Metastatic and Refractory Solid Tumors.
- ClinicalTrials.gov ID
- NCT01844661
- Acronym / sponsor ID
- EudraCT2008-000364-16
- Conditions
- Children, Solid Tumors, Metastases
- Keywords
- Mesenchymal stem cells, Oncolytic adenovirus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital Infantil Universitario Niño Jesús, Madrid, SpainUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 1 May 2013 (estimated)
- 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.
The investigators will evaluate the safety of weekly infusions (n=6) of CELYVIR in children and adults with metastatic and refractory solid tumors. CELYVIR consists in bone marrow-derived autologous mesenchymal stem cells (MSCs) infected with ICOVIR5, an oncolytic adenovirus. In addition to data on toxicities the investigators will evaluate clinical response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CELYVIR | Experimental | Biological: CELYVIRPatients will received weekly (n=6) IV infusion of Celyvir. |
Who may qualify
- Ages
- 6 months to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Children: Up to 18 yrs. Refractory to at least 2 previous therapy lines. Life expectancy more than 6 months. Measurable disease.
- Adults: 18-75 yrs. Refractory to at least 2 previous therapy lines. ECOG (Eastern Cooperative Oncology Group) <2. Measurable disease.
Key exclusion criteria (6 listed)
- Pregnancy.
- Central Nervous System metastasis.
- Experimental therapy during the previous month.
- Chemotherapy less than 3 weeks previous.
- Any organ functionally impaired.
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 |
|---|---|---|
| CELYVIRAlso: Bone marrow-derived autologous mesenchymal stem cells infected with ICOVIR5, an oncolytic adenovirus. | Biological | CELYVIR |
Primary outcome
Adverse effects after intravenous infusions
Time frame: 48 hours after each infusion
We will record any sign or symptom that could be related to the infusion of Celyvir.
1 secondary outcome
Clinical outcome
Time frame: Up to 2 months after the last infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
- Derived from this study: PubMed 33737338Morales-Molina A, Gambera S, Leo A, Garcia-Castro J. Combination immunotherapy using G-CSF and oncolytic virotherapy reduces tumor growth in osteosarcoma. J Immunother Cancer. 2021 Mar;9(3):e001703. doi: 10.1136/jitc-2020-001703.
- Derived from this study: PubMed 32053771Ruano D, Lopez-Martin JA, Moreno L, Lassaletta A, Bautista F, Andion M, Hernandez C, Gonzalez-Murillo A, Melen G, Alemany R, Madero L, Garcia-Castro J, Ramirez M. First-in-Human, First-in-Child Trial of Autologous MSCs Carrying the Oncolytic Virus Icovir-5 in Patients with Advanced Tumors. Mol Ther. 2020 Apr 8;28(4):1033-1042. doi: 10.1016/j.ymthe.2020.01.019. Epub 2020 Jan 21.
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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.
Manuel Ramírez, MD PhD principal investigator
Hospital Universitario Niño Jesús
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CELYVIR in people with Children and Solid Tumors, run by Hospital Infantil Universitario Niño Jesús, Madrid, Spain 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 2 inclusion and 6 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 19 Feb 2016. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse effects after intravenous infusions (time frame: 48 hours after each infusion). 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 NCT01844661, 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 19 Feb 2016.