MelanomaPhase 1/2NCT00716495
Safety and Pharmacodynamic Study of a New Formulation, AGI - 101H Vaccine in the Treatment of Advanced Melanoma
A Phase 1/2 study testing AGI-101H Vaccine in people with Melanoma, run by AGIRx Ltd. at 1 site in Poland.
Trial summary
In this open-label study of patients with advanced melanoma 20 evaluable patients will be recruited. The drug substance, AGI-101H, is a whole cell, allogeneic melanoma vaccine, representing a mixture (1:1 ratio) of two therapeutic gene modified human melanoma cell lines, referred to as Mich1H6 and Mich2H6, which has… Read more about this study
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have given signed informed consent for participation in the study prior to any study-related procedures being performed and not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care
- Age ≥18 years of age and ≤75 years of age
- Histologically confirmed, unresectable stage 3 or 4 measurable (RECIST criteria), cutaneous melanoma or unknown primary with melanoma metastases
- Life expectancy of at least 30 weeks and an ECOG performance status of X 1
- Adequate renal and liver function as defined by serum creatinine and total bilirubin levels no greater than 1.5 times the Investigational Site's upper normal laboratory limits
- Normal clotting
- The patient is willing and able to comply with the protocol for the duration of the study, including 2 hours of follow up observation after the injections (until DMC lifts it after analysis of the first 20 injections) during the course of the trial, examinations and punch biopsies of the vaccination sites 48 hrs post vaccine 1 (week 0) and 8 (week14).
Who cannot join
- Any previous participation in another trial with the AGI - 101 vaccine
- Ocular or mucosal melanoma
- Pregnant or breast-feeding women, or women of childbearing potential unless effective methods of contraception are used (lack of childbearing potential is met by being post-menopausal, being surgically sterile, practicing contraception with an oral contraceptive or other hormonal therapy [e.g. hormone implants], intra-uterine device, diaphragm with spermicide or condom with spermicide, or being sexually inactive)
- Radiotherapy to target lesions or immunotherapy (including treatment with Interferon or Interleukin-2 and systemic glucocorticosteroids) during the four weeks prior to the start of study treatment.
- Any previous treatment with systemic chemotherapy for advanced melanoma
- Brain metastases
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- Major surgery in the four weeks prior to the start of study treatment
- Patients who are poor medical risks due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent
- Patients who are known to be serologically positive for Hepatitis B (patients vaccinated against Hepatitis B are accepted), Hepatitis C or HIV
- States causing significant immunosuppression (e.g. organ transplantation or haemodialysis).
- Simultaneous participation in any other study involving investigational drugs or having participated in a study less than 4 weeks prior to start of study treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/IIa, Open-label Bridging Safety and Pharmacodynamic Study of a New Formulation of 6 Month Extended Dosing With AGI - 101H Vaccine in the Treatment of Patients With Advanced Melanoma
In this open-label study of patients with advanced melanoma 20 evaluable patients will be recruited.
The drug substance, AGI-101H, is a whole cell, allogeneic melanoma vaccine, representing a mixture (1:1 ratio) of two therapeutic gene modified human melanoma cell lines, referred to as Mich1H6 and Mich2H6, which has been gamma-irradiated to render the cells non-proliferative
Patients will receive treatment for up to 26 weeks. Progression at any time point requiring systemic treatment with, for example with chemotherapy or cytokines will lead to withdrawal of this patient from the study.
The dose chosen is 5 x 107 viable cells/dose.
Read the detailed description
Total number of patients: 20 evaluable patients will be enrolled in the study.
Dosage: 5 x 107 live cells. No dose modification is planned.
Administration: Subcutaneous (s.c.)
Duration of treatment: Patients will receive treatment for up to 26 weeks. Progression at any time point requiring systemic treatment with, for example with chemotherapy or cytokines will lead to withdrawal of this patient from the study. All surviving patients of this AGITAM trial will be offered the opportunity to transfer to a follow-up treatment protocol with AGI - 101H. In this case treatment may continue every 4 - 8 weeks until progression or death or withdrawal unless such therapy is contraindicated or patient does not wish to continue.
Reference therapy: Not applicable.
Description of medicinal product: The drug substance, AGI-101H, is a whole cell, allogeneic melanoma vaccine, representing a mixture (1:1 ratio) of two therapeutic genemodified human melanoma cell lines, referred to as Mich1H6 and Mich2H6, which has been gamma-irradiated to render the cells non-proliferative. There is no recommended International Non-proprietary (INN) Name for the drug substance.
Methodology: In this open-label study of patients with advanced melanoma, one dose of AGI - 101H vaccine will be administered s.c.. 20 evaluable patients will be recruited. An independent data monitoring committee (DMC) will review all safety data after the first 10 injections and then after another 10 injections (20 injections in total). Up to that second DMC meeting all patients have to stay in the hospital for a 2 hours observation; after the analysis of the 20 vaccinations the DMC will review the safety data and may recommend reverting to normal outpatients setting.
- Conditions
- Melanoma
- Being tested
- AGI-101H Vaccine
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGI-101H VaccineBiological
Each patient will receive one dose of AGI - 101H containing 5 x 107 viable cells, administered s.c. for up to 26 weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety profile of AGI-101H
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: problems in funding
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 1/2
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- AGIRx Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Margaret Gralinska, Study director, AGIRx (Active Gene Interventions) Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716495
- Sponsor's protocol ID
- AGI - 101H/01-2007
- Status last verified
- Apr 2016
- First submitted
- 15 Jul 2008
- Last updated
- 22 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa, Open-label Bridging Safety and Pharmacodynamic Study of a New Formulation of 6 Month Extended Dosing With AGI - 101H Vaccine in the Treatment of Patients With Advanced Melanoma
- ClinicalTrials.gov ID
- NCT00716495
- Acronym / sponsor ID
- AGI - 101H/01-2007
- Conditions
- Melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: problems in funding
- Enrolment
- 5 participants (actual)
- Lead sponsor
- AGIRx Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 16 Jul 2008 (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.
In this open-label study of patients with advanced melanoma 20 evaluable patients will be recruited.
The drug substance, AGI-101H, is a whole cell, allogeneic melanoma vaccine, representing a mixture (1:1 ratio) of two therapeutic gene modified human melanoma cell lines, referred to as Mich1H6 and Mich2H6, which has been gamma-irradiated to render the cells non-proliferative
Patients will receive treatment for up to 26 weeks. Progression at any time point requiring systemic treatment with, for example with chemotherapy or cytokines will lead to withdrawal of this patient from the study.
The dose chosen is 5 x 107 viable cells/dose.
Detailed description
Total number of patients: 20 evaluable patients will be enrolled in the study.
Dosage: 5 x 107 live cells. No dose modification is planned.
Administration: Subcutaneous (s.c.)
Duration of treatment: Patients will receive treatment for up to 26 weeks. Progression at any time point requiring systemic treatment with, for example with chemotherapy or cytokines will lead to withdrawal of this patient from the study. All surviving patients of this AGITAM trial will be offered the opportunity to transfer to a follow-up treatment protocol with AGI - 101H. In this case treatment may continue every 4 - 8 weeks until progression or death or withdrawal unless such therapy is contraindicated or patient does not wish to continue.
Reference therapy: Not applicable.
Description of medicinal product: The drug substance, AGI-101H, is a whole cell, allogeneic melanoma vaccine, representing a mixture (1:1 ratio) of two therapeutic genemodified human melanoma cell lines, referred to as Mich1H6 and Mich2H6, which has been gamma-irradiated to render the cells non-proliferative. There is no recommended International Non-proprietary (INN) Name for the drug substance.
Methodology: In this open-label study of patients with advanced melanoma, one dose of AGI - 101H vaccine will be administered s.c.. 20 evaluable patients will be recruited. An independent data monitoring committee (DMC) will review all safety data after the first 10 injections and then after another 10 injections (20 injections in total). Up to that second DMC meeting all patients have to stay in the hospital for a 2 hours observation; after the analysis of the 20 vaccinations the DMC will review the safety data and may recommend reverting to normal outpatients setting.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must have given signed informed consent for participation in the study prior to any study-related procedures being performed and not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care
- Age ≥18 years of age and ≤75 years of age
- Histologically confirmed, unresectable stage 3 or 4 measurable (RECIST criteria), cutaneous melanoma or unknown primary with melanoma metastases
- Life expectancy of at least 30 weeks and an ECOG performance status of X 1
- Adequate renal and liver function as defined by serum creatinine and total bilirubin levels no greater than 1.5 times the Investigational Site's upper normal laboratory limits
Key exclusion criteria (11 listed)
- Any previous participation in another trial with the AGI - 101 vaccine
- Ocular or mucosal melanoma
- Pregnant or breast-feeding women, or women of childbearing potential unless effective methods of contraception are used (lack of childbearing potential is met by being post-menopausal, being surgically sterile, practicing contraception with an oral contraceptive or other hormonal therapy [e.g. hormone implants], intra-uterine device, diaphragm with spermicide or condom with spermicide, or being sexually inactive)
- Radiotherapy to target lesions or immunotherapy (including treatment with Interferon or Interleukin-2 and systemic glucocorticosteroids) during the four weeks prior to the start of study treatment.
- Any previous treatment with systemic chemotherapy for advanced melanoma
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 |
|---|---|---|
| AGI-101H VaccineEach patient will receive one dose of AGI - 101H containing 5 x 107 viable cells, administered s.c. for up to 26 weeks. | Biological | – |
Primary outcome
The safety profile of AGI-101H
Time frame: 9 months
Results and safety
The study was stopped early (reason given: problems in funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 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.
Margaret Gralinska study director
AGIRx (Active Gene Interventions) Ltd
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 AGI-101H Vaccine in people with Melanoma, run by AGIRx Ltd. at 1 site in Poland.
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 7 inclusion and 11 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 22 Apr 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 Poland. 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 was stopped early (reason given: problems in funding). 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?
The safety profile of AGI-101H (time frame: 9 months). 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 22 Apr 2016.