Metastatic MelanomaPhase 1/2NCT01082887
A Study of Immunotherapy With TIL (Tumor Infiltrating Lymphocytes) in Combination With Intra-tumoral Injections of Interferon Gamma-adenovirus (Ad-IFNg) in Patients With Stage IIIc or Stage IV Metastatic Melanoma (AJCC)(Protocol TIL-Ad-INFg)
A Phase 1/2 study testing TIL-Ad-INFg in people with Metastatic Melanoma, run by Nantes University Hospital at 1 site in France.
Trial summary
The main objective of this study is to evaluate the clinical and biologic toxicity of cell therapy by adoptive transfer of TIL in combination with intra-tumoral injections of Ad-INFg. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- TIL-Ad-INFg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2010to Oct 2012
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Negative viral serology (HIV ½, p24 Ag, HTLV 1 / 2, B and C hepatitis)
Who cannot join
- For female : the patient is pregnant or lactating or not using contraception and proved by a negative pregnancy test
- Positive viral serology for HIV ½, p24 Ag, HTLV 1 / 2 or B and C hepatitis
- History or current manifestations of severe progressive heart disease (congestive heart failure, coronary artery disease, uncontrolled arterial hypertension, serious rhythm disorders or ECG signs of previous myocardial infarction)
- Any serious illness, acute or chronic, e.g. active infection requiring antibiotics, bleeding disorders or any other condition that requires concomitant medications not allowed during this study
- Presence of a second active cancer except in situ cervical cancer or skin carcinoma
- Intercurrent disease requiring a corticosteroid treatment or a treatment with interferon-α
Show all 17Show fewer
- Any autoimmune disease including active diabetes mellitus or immunodeficiency. Vitiligo in not an exclusion criteria
- Uncontrolled thyroid dysfunction
- Concurrently participation in a biomedical research (drug or radiotherapy) within the month preceding inclusion
- Metastatic lymph node stage alone with an indication of lymphadenectomy
- Brain or bone metastases discovered by radiological examination during the inclusion assessment
- Surgically resectable metastases
- Ocular melanoma
- More than one line of chemotherapy for treatment of melanoma
- Chemotherapy, immunotherapy or radiotherapy within 4 weeks before baseline (6 weeks for nitroso-ureas and mitomycin C)
- Contraindication for the use of vasopressor agents
- Treatment with molecules in pre-marketing development or whose development is finished less than 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Study of Immunotherapy With TIL (Tumor Infiltrating Lymphocytes) in Combination With Intra-tumoral Injections of Interferon Gamma-adenovirus (Ad-IFNg) in Patients With Stage IIIc or Stage IV Metastatic Melanoma (AJCC)
The main objective of this study is to evaluate the clinical and biologic toxicity of cell therapy by adoptive transfer of TIL in combination with intra-tumoral injections of Ad-INFg.
- Conditions
- Metastatic Melanoma
- Being tested
- TIL-Ad-INFg
- Keywords
- Immunotherapy TIL (Tumor Infiltrating Lymphocytes), Intra-tumoral injection, Interferon gamma-adenovirus(Ad-IFNg), Metastatic melanoma, A stage IIIc/IV metastatic melanoma with nodal relapse, in transit metastasis, cutaneous unresectable metastases, visceral metastases
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIL-Ad-INFgOther
After verification of inclusion and non-inclusion criteria and after obtaining informed consent from the patients, a tumor sample will be taken for sterile production of TIL. Patients will receive intra-tumoral injections of Ad-INFg every 15 days from J-15 to M2, then every month from M3 to M11 or until disease progression. The Ad-INFg will be administered by intra-tumoral injection at a dose of 5x1010 vp (viral particles) per lesion. A maximum of 6 lesions will be treated simultaneously. They will also receive two infusion of TIL at M0 (Cycle 1) and M1 (Cycle 2) by intravenous infusion lasting 30 to 65 minutes followed by subcutaneous injections of IL2 from J1 to J5 and from J8 to J12 of each cycle.An evaluation of injected and not injected tumoral lesions including photographs will be realised at the pre-inclusion visit, J-15, M0 and every month until M12.
| Study group | Role | What they receive |
|---|---|---|
| TIL-Ad-INFg | Experimental | Not described Receives: Other: TIL-Ad-INFg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and biological toxicity of combined treatment TIL, IL2 et Ad-INFg
The evaluation of clinical and biological toxicity of combined treatment including infusion of TIL associated with subcutaneous injections of low-doses of IL-2 and intra-tumoral injections of Ad-IFNg will be performed according to clinical and biological criteria defined by NCI (Common Toxicity Criteria - version 3.0, August 2006).
Measured: 12 months
Secondary outcomes (5)
Objective response rate
The evaluation of the objective response rate
Measured: 12 months
Tumoral response
The evaluation of the tumoral response of injected lesions every month
Measured: 12 months
Progression-free survival
The evaluation of the progression-free survival,
Measured: 12 months
Overall survival
The evaluation of the overall survival
Measured: 12 months
Immunological response
The evaluation of the immunological response
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brigitte DRENO, Profesor, Principal investigator, Nantes University HospitalGaëlle QUEREUX, Doctor, Study chair, Nantes University HospitalAnabelle BROCARD, Doctor, Study chair, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082887
- Sponsor's protocol ID
- BRD/09/05-R
- Other IDs
- 2009-013087-38, 2009
- Status last verified
- Aug 2016
- First submitted
- 8 Mar 2010
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Immunotherapy With TIL (Tumor Infiltrating Lymphocytes) in Combination With Intra-tumoral Injections of Interferon Gamma-adenovirus (Ad-IFNg) in Patients With Stage IIIc or Stage IV Metastatic Melanoma (AJCC)
- ClinicalTrials.gov ID
- NCT01082887
- Acronym / sponsor ID
- BRD/09/05-R
- Conditions
- Metastatic Melanoma
- Keywords
- Immunotherapy TIL (Tumor Infiltrating Lymphocytes), Intra-tumoral injection, Interferon gamma-adenovirus(Ad-IFNg), Metastatic melanoma, A stage IIIc/IV metastatic melanoma with nodal relapse, in transit metastasis, cutaneous unresectable metastases, visceral metastases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 9 Mar 2010 (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 objective of this study is to evaluate the clinical and biologic toxicity of cell therapy by adoptive transfer of TIL in combination with intra-tumoral injections of Ad-INFg.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TIL-Ad-INFg | Experimental | Other: TIL-Ad-INFg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Negative viral serology (HIV ½, p24 Ag, HTLV 1 / 2, B and C hepatitis)
Key exclusion criteria (17 listed)
- For female : the patient is pregnant or lactating or not using contraception and proved by a negative pregnancy test
- Positive viral serology for HIV ½, p24 Ag, HTLV 1 / 2 or B and C hepatitis
- History or current manifestations of severe progressive heart disease (congestive heart failure, coronary artery disease, uncontrolled arterial hypertension, serious rhythm disorders or ECG signs of previous myocardial infarction)
- Any serious illness, acute or chronic, e.g. active infection requiring antibiotics, bleeding disorders or any other condition that requires concomitant medications not allowed during this study
- Presence of a second active cancer except in situ cervical cancer or skin carcinoma
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 |
|---|---|---|
| TIL-Ad-INFgAfter verification of inclusion and non-inclusion criteria and after obtaining informed consent from the patients, a tumor sample will be taken for sterile production of TIL. Patients will receive intra-tumoral injections of Ad-INFg every 15 days from J-15 to M2, then every month from M3 to M11 or until disease progression. The Ad-INFg will be administered by intra-tumoral injection at a dose of 5x1010 vp (viral particles) per lesion. A maximum of 6 lesions will be treated simultaneously. They will also receive two infusion of TIL at M0 (Cycle 1) and M1 (Cycle 2) by intravenous infusion lasting 30 to 65 minutes followed by subcutaneous injections of IL2 from J1 to J5 and from J8 to J12 of each cycle.An evaluation of injected and not injected tumoral lesions including photographs will be realised at the pre-inclusion visit, J-15, M0 and every month until M12. | Other | TIL-Ad-INFg |
Primary outcome
Clinical and biological toxicity of combined treatment TIL, IL2 et Ad-INFg
Time frame: 12 months
The evaluation of clinical and biological toxicity of combined treatment including infusion of TIL associated with subcutaneous injections of low-doses of IL-2 and intra-tumoral injections of Ad-IFNg will be performed according to clinical and biological criteria defined by NCI (Common Toxicity Criteria - version 3.0, August 2006).
5 secondary outcomes
Objective response rate
Time frame: 12 months
Tumoral response
Time frame: 12 months
Progression-free survival
Time frame: 12 months
Overall survival
Time frame: 12 months
Immunological response
Time frame: 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 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.
Brigitte DRENO, Profesor principal investigator
Nantes University Hospital
Gaëlle QUEREUX, Doctor study chair
Nantes University Hospital
Anabelle BROCARD, Doctor study chair
Nantes University Hospital
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 TIL-Ad-INFg in people with Metastatic Melanoma, run by Nantes University Hospital at 1 site in France.
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 1 inclusion and 17 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 8 Aug 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 France. 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. 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?
Clinical and biological toxicity of combined treatment TIL, IL2 et Ad-INFg (time frame: 12 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 8 Aug 2016; AzTrials last refreshed its copy on 7 Nov 2026.