Malignant Glioma of BrainPhase 2HGG-01NCT00870181
ADV-TK Improves Outcome of Recurrent High-Grade Glioma
A Phase 2 study testing ADV-TK/GCV, Surgery and systemic chemotherapy in people with Malignant Glioma of Brain and Glioblastoma, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Malignant gliomas are the most common primary brain tumor in adults, but the prognosis for patients with these tumors remains poor despite advances in diagnosis and standard therapies such as surgery, radiation therapy, and chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Glioma of Brain, Glioblastoma
- What is being tested?
- ADV-TK/GCV, Surgery and systemic chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- Jan 2008to Dec 2012
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed WHO grades 3 to 4 malignant glioma
- Diagnosed recurrence or progression by clinical or radiological evidence
- Fit for intraarterial infusion and intravenous chemotherapy
- Adequate hepatic, renal, and hematologic function.
- Legal age ≥18 years
- Life expectancy ≥12 weeks
- Eastern Cooperative Oncology Group performance (ECOG) ≥2
- Chemotherapy completion ≥4 weeks prior and recovery from drug induced toxicities.
Who cannot join
- Active pregnancy
- Prior gene therapy
- Second primary tumor
- Gravidity, lactation, hypersensitivity to antiviral drugs, immunologic deficit, active uncontrolled infections
- Requiring treatment with warfarin or any other anticoagulants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adenovirus-Mediated Delivery of Herpes Simplex Virus Thymidine Kinase Administration Improves Outcome of Recurrent High-Grade Glioma
Malignant gliomas are the most common primary brain tumor in adults, but the prognosis for patients with these tumors remains poor despite advances in diagnosis and standard therapies such as surgery, radiation therapy, and chemotherapy. The advantages of ADV-TK gene therapy highlight its efficacy and safety for glioma patients. This clinical trial was conducted to assess the anti-tumor efficacy and safety of intraarterial cerebral infusion of replication-deficient adenovirus mutant ADV-TK, in combination with systemic intravenous GCV administration in patients with recurrent high-grade glioma.
- Conditions
- Malignant Glioma of Brain, Glioblastoma
- Being tested
- ADV-TK/GCV, Surgery, systemic chemotherapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADV-TK/GCVBiological
gene therapy
SurgeryProcedure or surgery
systemic chemotherapyDrug
| Study group | Role | What they receive |
|---|---|---|
| ADV-TK/GCV | Experimental | ADV-TK was administered via intraarterial cerebral infusion. Systemic GCV therapy was delivered at a dose of 5mg/kg intravenous, every 12 h at 36 hours after ADV-TK therapy. Receives: Biological: ADV-TK/GCV |
| Control group | Active comparator | Patients received surgery or systemic chemotherapy or palliative care. Receives: Procedure: Surgery; Drug: systemic chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point was 6-month progression-free survival rate (PFS-6)
Measured: 6 months
Secondary outcomes (4)
progression-free survival (PFS)
Measured: 3 years
overall survival (OS)
Measured: 3 years
safety
Measured: 1. at the time during treatments; 2. at 6-month; 3. at the end of 1-year following-up; 4. at the end of 2-year following up; 5. at the time the patient censored.
clinical benefit
the rate of complete response, plus partial response, plus stable disease
Measured: at the end of 2nd ADK-TK/GCV therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startJan 2008
- Primary completionDec 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Glioma of BrainStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding Ma, Huazhong University of Science and Technology
- Investigators
- Ma Ding, M.D., Study director, Tongji Hospital of HUST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870181
- Sponsor's protocol ID
- 2009HGG-01
- Acronym
- HGG-01
- Status last verified
- Jun 2013
- First submitted
- 26 Mar 2009
- Last updated
- 25 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ji N, Weng D, Liu C, Gu Z, Chen S, Guo Y, Fan Z, Wang X, Chen J, Zhao Y, Zhou J, Wang J, Ma D, Li N. Adenovirus-mediated delivery of herpes simplex virus thymidine kinase administration improves outcome of recurrent high-grade glioma. Oncotarget. 2016 Jan 26;7(4):4369-78. doi: 10.18632/oncotarget.6737.
PubMed 26716896
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adenovirus-Mediated Delivery of Herpes Simplex Virus Thymidine Kinase Administration Improves Outcome of Recurrent High-Grade Glioma
- ClinicalTrials.gov ID
- NCT00870181
- Acronym / sponsor ID
- HGG-01 / 2009HGG-01
- Conditions
- Malignant Glioma of Brain, Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Beijing Chao Yang Hospital, Beijing Friendship Hospital
- Study start
- Jan 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Mar 2009 (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.
Malignant gliomas are the most common primary brain tumor in adults, but the prognosis for patients with these tumors remains poor despite advances in diagnosis and standard therapies such as surgery, radiation therapy, and chemotherapy. The advantages of ADV-TK gene therapy highlight its efficacy and safety for glioma patients. This clinical trial was conducted to assess the anti-tumor efficacy and safety of intraarterial cerebral infusion of replication-deficient adenovirus mutant ADV-TK, in combination with systemic intravenous GCV administration in patients with recurrent high-grade glioma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADV-TK/GCV | Experimental | Biological: ADV-TK/GCVADV-TK was administered via intraarterial cerebral infusion. Systemic GCV therapy was delivered at a dose of 5mg/kg intravenous, every 12 h at 36 hours after ADV-TK therapy. |
| Control group | Active comparator | Procedure: Surgery, Drug: systemic chemotherapyPatients received surgery or systemic chemotherapy or palliative care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed WHO grades 3 to 4 malignant glioma
- Diagnosed recurrence or progression by clinical or radiological evidence
- Fit for intraarterial infusion and intravenous chemotherapy
- Adequate hepatic, renal, and hematologic function.
- Legal age ≥18 years
Key exclusion criteria (5 listed)
- Active pregnancy
- Prior gene therapy
- Second primary tumor
- Gravidity, lactation, hypersensitivity to antiviral drugs, immunologic deficit, active uncontrolled infections
- Requiring treatment with warfarin or any other anticoagulants
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 |
|---|---|---|
| ADV-TK/GCVgene therapy | Biological | ADV-TK/GCV |
| Surgery | Procedure or surgery | Control group |
| systemic chemotherapy | Drug | Control group |
Primary outcome
The primary end point was 6-month progression-free survival rate (PFS-6)
Time frame: 6 months
4 secondary outcomes
progression-free survival (PFS)
Time frame: 3 years
overall survival (OS)
Time frame: 3 years
safety
Time frame: 1. at the time during treatments; 2. at 6-month; 3. at the end of 1-year following-up; 4. at the end of 2-year following up; 5. at the time the patient censored.
clinical benefit
Time frame: at the end of 2nd ADK-TK/GCV therapy
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 25 Jun 2013.
- Derived from this study: PubMed 26716896Ji N, Weng D, Liu C, Gu Z, Chen S, Guo Y, Fan Z, Wang X, Chen J, Zhao Y, Zhou J, Wang J, Ma D, Li N. Adenovirus-mediated delivery of herpes simplex virus thymidine kinase administration improves outcome of recurrent high-grade glioma. Oncotarget. 2016 Jan 26;7(4):4369-78. doi: 10.18632/oncotarget.6737.
Related trials for Malignant Glioma of Brain
RecruitingPhase 1
A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma
Glioblastoma Multiforme of Brain, Glioma
Not yet recruitingPhase 1
IL-8 Receptor-modified CD70 CAR T Cell Therapy in CD70+ Newly Diagnosed and Recurrent Pediatric High-grade Glioma (pHGG) and Newly Diagnosed Diffuse Intrinsic Pontine Glioma (ndDIPG)
High-grade Glioma, Diffuse Intrinsic Pontine Glioma
RecruitingPhase 1
A Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM)
Adult Glioblastoma, High Grade Glioma
RecruitingPhase 1/2
000860: A Phase I/II Study of Zotiraciclib for Recurrent Malignant Gliomas With Isocitrate Dehydrogenase 1 or 2 (IDH1 or IDH2) Mutations
Brain Tumor, Cancer
Not yet recruitingPhase 1
A Study of SRN-101 Administered Prior to Surgical Resection in Adults With Recurrent High-Grade Glioma.
Recurrent High-Grade Gliomas, Brain Neoplasm
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.
Ma Ding, M.D. study director
Tongji Hospital of HUST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ADV-TK/GCV, Surgery and systemic chemotherapy in people with Malignant Glioma of Brain and Glioblastoma, run by Huazhong University of Science and Technology at 1 site in China.
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 8 inclusion and 5 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 25 Jun 2013. 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 China. 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 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?
The primary end point was 6-month progression-free survival rate (PFS-6) (time frame: 6 months). 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 NCT00870181, which also lists 1 linked publication.
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 25 Jun 2013.