MelanomaPhase 1NCT01935453
A Phase I Study of Recombinant hGM-CSF Herpes Simplex Virus to Treat Cancer
A Phase 1 study testing Recombinant hGM-CSF Herpes Simplex Virus Injection in people with Melanoma and Liver Cancer, run by OrienGene Biotechnology Ltd. at 2 sites in China.
Trial summary
The main purpose of this study is to study the safety of OrienX010 in the treatment of kinds of solid tumors such as melanoma,liver cancer,pancreatic cancer and lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Melanoma, Liver Cancer, Pancreatic Cancer
- What is being tested?
- Recombinant hGM-CSF Herpes Simplex Virus Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesChina
- Study dates
- May 2012to May 2014
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients in advanced stage of malignant tumor diagnosticated by pathologic and cytological analysis.
- lack of routine effective treatment,failure of routine treatment or relapse
- age of 18-70,ECOG 0-2 and estimated survival is above 3 months
- had an interval of above 4 weeks since exposure to chemotherapy or radiotherapy and above 6 weeks since exposure to nitrosoureas or mitomycin C.
Who cannot join
- Serious internal diseases
- uncontrolled primary and metastatic brain tumor
- sizes of tumor does not meet the requirement of injection
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Shijitan Hospital,CMU
Beijing, Beijing Municipality, 100038
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Phase I Study of Recombinant hGM-CSF Herpes Simplex Virus
The main purpose of this study is to study the safety of OrienX010 in the treatment of kinds of solid tumors such as melanoma,liver cancer,pancreatic cancer and lung cancer.
- Conditions
- Melanoma, Liver Cancer, Pancreatic Cancer, Lung Cancer
- Being tested
- Recombinant hGM-CSF Herpes Simplex Virus Injection
- Medical subject headings
- Melanoma, Liver Neoplasms, Pancreatic Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant hGM-CSF Herpes Simplex Virus InjectionBiological
Also called OrienX010
| Study group | Role | What they receive |
|---|---|---|
| Recombinant HSV-1 Injection | Experimental | Intratumoral injection Single dose: 4 groups -- 106 pfu, 107 pfu, 108 pfu and 4×108 pfu Multiple dose (three injections, every 2 weeks): 2 groups -- 108, 108, 108pfu and 4×108, 4×108, 4×108pfu Continuous treatment: Upon 4 weeks follow-up after administration, if the investigator deems that continuous treatment will benefit subjects, continuous intratumoral injection may be given, and the interval between each injection will be 2 weeks. Receives: Biological: Recombinant hGM-CSF Herpes Simplex Virus Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploring the MTD of OrienX010 according to DLT,which defined as the serious degree of adverse events relates to the medicine not less than grade 3 of CTCAE v4.03
Measured: 28 days after the last administration
Secondary outcomes (1)
Using RECIST 1.1 to evaluate the preliminary efficacy of OrienX010
Measured: 28 days after the last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startMay 2012
- Primary completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrienGene Biotechnology Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- START Shanghai, Beijing Bozhiyin T&S Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Jin Li, MD, Principal investigator, Fudan UniversityJun Ren, MD, Principal investigator, Beijing Shijitan Hospital,CMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935453
- Sponsor's protocol ID
- OrienGene-01
- Status last verified
- Dec 2011
- First submitted
- 23 Aug 2013
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Recombinant hGM-CSF Herpes Simplex Virus
- ClinicalTrials.gov ID
- NCT01935453
- Acronym / sponsor ID
- OrienGene-01
- Conditions
- Melanoma, Liver Cancer, Pancreatic Cancer, Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- OrienGene Biotechnology Ltd.Industry (pharma, biotech, devices)
- Collaborators
- START Shanghai, Beijing Bozhiyin T&S Co., Ltd.
- Study start
- May 2012
- Primary completion
- May 2014 (actual)
- First posted
- 5 Sep 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 main purpose of this study is to study the safety of OrienX010 in the treatment of kinds of solid tumors such as melanoma,liver cancer,pancreatic cancer and lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recombinant HSV-1 Injection | Experimental | Biological: Recombinant hGM-CSF Herpes Simplex Virus InjectionIntratumoral injection Single dose: 4 groups -- 106 pfu, 107 pfu, 108 pfu and 4×108 pfu Multiple dose (three injections, every 2 weeks): 2 groups -- 108, 108, 108pfu and 4×108, 4×108, 4×108pfu Continuous treatment: Upon 4 weeks follow-up after administration, if the investigator deems that continuous treatment will benefit subjects, continuous intratumoral injection may be given, and the interval between each injection will be 2 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients in advanced stage of malignant tumor diagnosticated by pathologic and cytological analysis.
- lack of routine effective treatment,failure of routine treatment or relapse
- age of 18-70,ECOG 0-2 and estimated survival is above 3 months
- had an interval of above 4 weeks since exposure to chemotherapy or radiotherapy and above 6 weeks since exposure to nitrosoureas or mitomycin C.
Key exclusion criteria (3 listed)
- Serious internal diseases
- uncontrolled primary and metastatic brain tumor
- sizes of tumor does not meet the requirement of injection
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 |
|---|---|---|
| Recombinant hGM-CSF Herpes Simplex Virus InjectionAlso: OrienX010 | Biological | Recombinant HSV-1 Injection |
Primary outcome
Exploring the MTD of OrienX010 according to DLT,which defined as the serious degree of adverse events relates to the medicine not less than grade 3 of CTCAE v4.03
Time frame: 28 days after the last administration
1 secondary outcome
Using RECIST 1.1 to evaluate the preliminary efficacy of OrienX010
Time frame: 28 days after the last administration
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 1 Sep 2016.
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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.
Jin Li, MD principal investigator
Fudan University
Jun Ren, MD principal investigator
Beijing Shijitan Hospital,CMU
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant hGM-CSF Herpes Simplex Virus Injection in people with Melanoma and Liver Cancer, run by OrienGene Biotechnology Ltd. at 2 sites 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 4 inclusion and 3 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 1 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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 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?
Exploring the MTD of OrienX010 according to DLT,which defined as the serious degree of adverse events relates to the medicine not less than grade 3 of CTCAE v4.03 (time frame: 28 days after the last administration). 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 1 Sep 2016.