Locally Advanced or Metastatic MelanomaPhase 1NCT01864759
Phase I Endovenous Administration of Oncolytic Adenovirus ICOVIR-5 in Patients With Advanced or Metastatic Melanoma
A Phase 1 study testing ICOVIR-5 in people with Locally Advanced or Metastatic Melanoma, run by Institut Català d'Oncologia at 1 site in Spain.
Trial summary
The investigators will evaluate the safety of a single endovenous infusion of ICOVIR5 in adults with locally advanced and metastatic melanoma. ICOVIR5 consists in a conditionally replicative or oncolytic adenovirus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Melanoma
- What is being tested?
- ICOVIR-5
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSpain
- Study dates
- 11 Jan 2013to 26 Apr 2017
- 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
- Malignant melanoma advanced or metastatic.
- Other than 18 years
- Karnofsky index > 60 %
- Life expectancy > 3 months
- ALT/AST <=2.5 times the upper normal limit
- Creatinine clearance >= 50 ml/min.
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- Bilirubin <25 umol/l
- Alkaline phosphatase <= 2.5 time upper normal limit
- Normal bone marrow function: Neutrophils >=1.5 E9/L, platelets >= 1E11/L, hemoglobin >= 100 g/l, Normal prothrombin time and thromboplastin time,
- HIV negative
- Measurable disease
- Signed informed consent.
Who cannot join
- Geographical, social or psychological conditions that may impair the protocol compliance.
- Active infections or other severe medical status.
- History of liver disease.
- Other or concomitant treatments for melanoma or investigational product.
- Previous participation in studies with adenovirus.
- Virus diseases diagnosed two weeks before inclusion.
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- Immunosuppressive concomitant treatments
- Concomitant malignant haematological disease.
- Patients having family members with immunodeficient status or disease
- Patients with Li Fraumeni syndrome or germinal retinoblastoma gene defects.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet Del Llobregat, Barcelona, 08908
About this study
Official title: Phase I Clinical Trial of Endovenous Administration of Conditionally Replicative Adenovirus ICOVIR-5 in Patients With Locally Advanced or Metastatic Melanoma
The investigators will evaluate the safety of a single endovenous infusion of ICOVIR5 in adults with locally advanced and metastatic melanoma. ICOVIR5 consists in a conditionally replicative or oncolytic adenovirus.
- Conditions
- Locally Advanced or Metastatic Melanoma
- Being tested
- ICOVIR-5
- Keywords
- melanoma, oncolytic, adenovirus, virotherapy, locally advanced, metastatic
- Medical subject headings
- Melanoma, Adenoviridae Infections, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICOVIR-5Biological
| Study group | Role | What they receive |
|---|---|---|
| ICOVIR5 | Experimental | ICOVIR-5 oncolytic adenovirus, single administration, endovenous, dose escalation from 1E11 vp to 1E13 vp. Receives: Biological: ICOVIR-5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
The highest dose where less than two out of three or six patients suffered dose limiting toxicity.
Measured: 4 weeks
Secondary outcomes (2)
Recommended dose
Measured: 4 weeks
Anti-tumour activity
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2013 (estimated)
- Study start11 Jan 2013
- Primary completion20 Dec 2016
- Study completion26 Apr 2017
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 Locally Advanced or Metastatic 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Català d'Oncologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ramon Salazar, MD PhD, Principal investigator, Institut Català d'OncologiaRamon Alemany, PhD, Study chair, Institut Català d'Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864759
- Sponsor's protocol ID
- ICOVIR5-2
- Other IDs
- 2008-005694-35, 2008
- Status last verified
- Aug 2017
- First submitted
- 22 May 2013
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cascallo M, Alonso MM, Rojas JJ, Perez-Gimenez A, Fueyo J, Alemany R. Systemic toxicity-efficacy profile of ICOVIR-5, a potent and selective oncolytic adenovirus based on the pRB pathway. Mol Ther. 2007 Sep;15(9):1607-15. doi: 10.1038/sj.mt.6300239. Epub 2007 Jun 19.
PubMed 17579575
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of Endovenous Administration of Conditionally Replicative Adenovirus ICOVIR-5 in Patients With Locally Advanced or Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT01864759
- Acronym / sponsor ID
- ICOVIR5-2
- Conditions
- Locally Advanced or Metastatic Melanoma
- Keywords
- melanoma, oncolytic, adenovirus, virotherapy, locally advanced, metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Institut Català d'OncologiaUniversity, hospital or other
- Study start
- 11 Jan 2013 (actual)
- Primary completion
- 20 Dec 2016 (actual)
- Study completion
- 26 Apr 2017 (actual)
- First posted
- 30 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 a single endovenous infusion of ICOVIR5 in adults with locally advanced and metastatic melanoma. ICOVIR5 consists in a conditionally replicative or oncolytic adenovirus.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICOVIR5 | Experimental | Biological: ICOVIR-5ICOVIR-5 oncolytic adenovirus, single administration, endovenous, dose escalation from 1E11 vp to 1E13 vp. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Malignant melanoma advanced or metastatic.
- Other than 18 years
- Karnofsky index > 60 %
- Life expectancy > 3 months
- ALT/AST <=2.5 times the upper normal limit
Key exclusion criteria (10 listed)
- Geographical, social or psychological conditions that may impair the protocol compliance.
- Active infections or other severe medical status.
- History of liver disease.
- Other or concomitant treatments for melanoma or investigational product.
- Previous participation in studies with adenovirus.
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 |
|---|---|---|
| ICOVIR-5 | Biological | ICOVIR5 |
Primary outcome
Maximum tolerated dose
Time frame: 4 weeks
The highest dose where less than two out of three or six patients suffered dose limiting toxicity.
2 secondary outcomes
Recommended dose
Time frame: 4 weeks
Anti-tumour activity
Time frame: 4 weeks
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 29 Aug 2017.
- Background: PubMed 17579575Cascallo M, Alonso MM, Rojas JJ, Perez-Gimenez A, Fueyo J, Alemany R. Systemic toxicity-efficacy profile of ICOVIR-5, a potent and selective oncolytic adenovirus based on the pRB pathway. Mol Ther. 2007 Sep;15(9):1607-15. doi: 10.1038/sj.mt.6300239. Epub 2007 Jun 19.
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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.
Ramon Salazar, MD PhD principal investigator
Institut Català d'Oncologia
Ramon Alemany, PhD study chair
Institut Català d'Oncologia
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 ICOVIR-5 in people with Locally Advanced or Metastatic Melanoma, run by Institut Català d'Oncologia 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 12 inclusion and 10 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 29 Aug 2017. 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 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?
Maximum tolerated dose (time frame: 4 weeks). 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 NCT01864759, 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 29 Aug 2017.