AzTrials
AzTrials

ImmunotherapyPhase 1/2NCT00720031

Treatment of Metastatic Melanoma With Autologous Melan-A/MART-1 Specific CTL Clones

A Phase 1/2 study testing autologous Melan-A/MART-1 specific CTL clones in people with Immunotherapy, run by Nantes University Hospital at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Most of HLA-A2 melanomas express Melan-A/MART-1 antigen and are recognized by tumor reactive Melan-A specific T lymphocytes. By using blood samples from HLA-A2 melanoma patients (stage III and IV), our goal is to produce a tumor reactive Melan-A specific T cell clones and to conduct a phase I-II clinical trial, based… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Immunotherapy
What is being tested?
autologous Melan-A/MART-1 specific CTL clones
Type of treatment
Injection or infusion
How many people
16 participants
Where
1 siteFrance
Study dates
Nov 2000to May 2008
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HLA-A2 melanoma patients with :
  • either loco-regional or lymph node metastasis
  • transit nodules not surgically resectable
  • measurable cutaneous or visceral metastasis
  • Patients' tumor express Melan-A/MART-1 antigen.
  • No chemotherapy treatment (except for Deticene used before the first T cell clones infusion) or radiotherapy or immunotherapy in the last 4 weeks before infusion.
Show all 12Show fewer
  • No other melanoma treatment during the protocol.
  • Life expectancy should be greater than 6 months.
  • General state with Karnowsky greater than 80, ECOG = 0, 1 or 2.
  • Patient should be negative for HIV and B and C hepatitis.
  • Biological parameters at the beginning of the study: leucocytes ³ 2000 elements per mm3, hemoglobin ³ 10.5g/dl, platelets ³ 100 000 per mm3, phosphatases alcalines transaminases £ 1 time 1/2 compared to the normal.
  • Signed informed consent

Who cannot join

  • Cardio-vascular pathologies, evoluting and uncontrolled, (severe HTA), cardiac deficiency, severe angor, severe arrhythmia.
  • Infectious pathologies evoluting and requiring antibiotherapy.
  • Patients HIV+.
  • Transplanted patients or patients suffering from severe auto-immune disease.
  • Psychiatric troubles that do not allow the protocol follow-up.
  • Pregnant or breast-feeding women.
  • No contraception.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Nantes University Hopspital

    Nantes, Pays de la Loire Region, 44093

Other trials in France

About this study

Most of HLA-A2 melanomas express Melan-A/MART-1 antigen and are recognized by tumor reactive Melan-A specific T lymphocytes. By using blood samples from HLA-A2 melanoma patients (stage III and IV), our goal is to produce a tumor reactive Melan-A specific T cell clones and to conduct a phase I-II clinical trial, based on the infusion of several millions to several billions of these lymphocytes to the patient, in order to induce passive immunity against this antigen. Production of the clones will be performed in the Unit for Cellular and Gene Therapy from Nantes University Hospital. Therapeutic response, safety treatment but also localization and survival of infused T cell clones will be assessed. This approach is expected to precise the ability of the clones to migrate within the tumor and to transfer specific immunity.

Conditions
Immunotherapy
Being tested
autologous Melan-A/MART-1 specific CTL clones
Keywords
Melanoma,, Melan-A tumor reactive T cell clones,, immunotherapy, HLA-A2 melanoma patients with, either loco-regional or lymphnode metastasis, transit nodules not surgically resectable, -measurable cutaneous or visceral metastasis ., Patients' tumor express Melan-A/MART-1 antigen.
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • autologous Melan-A/MART-1 specific CTL clonesBiological

    By using patients' blood, several million to several billion of Melan-A/MART1 tumor reactive T cell clone(s) will be produced in vitro, then infused to the patient, 3 to 6 months after collecting blood sample. During this production period of the T cell clone, the patient will be treated with deticene at the dose of 250mg/m2/j by IV for 4 days each month.

    After each T cell clone infusion (J1), the patient will receive IFN-α at the dose of 9 M/U 3 times a week for 4 weeks and Interleukin-2 at the dose of 9 M/U from Day 1 to day 5 and from Day 8 to Day 12.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the efficacy of an adoptive immunotherapy specific for Melan-A/MART1 antigen in metastatic melanoma patients whose tumor express this antigen but also HLA-A2

    Measured: one year

Secondary outcomes (3)

  1. Evaluate whether infused T cell clones migrate to tumor sites. For this purpose, infused T cell clones will be characterized according to their Vß and Valpha using antibodies and/or PCR

    Measured: after treatment

  2. Evaluate whether infused T cell clones transfer a specific immunity.

    Measured: J56 after treatment

  3. evaluate infused Melan-A/MART1 reactive T cell clones tolerance

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2008 (estimated)
  2. Study startNov 2000
  3. Primary completionMay 2008
  4. Study completionMay 2008

Resources

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
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00720031
Sponsor's protocol ID
BRD 98/9-C
Status last verified
Jul 2008
First submitted
18 Jul 2008
Last updated
24 Jul 2008
Results posted
No
Data monitoring committee
No

Publications

  • Khammari A, Nguyen JM, Saint-Jean M, Knol AC, Pandolfino MC, Quereux G, Brocard A, Peuvrel L, Saiagh S, Bataille V, Limacher JM, Dreno B. Adoptive T cell therapy combined with intralesional administrations of TG1042 (adenovirus expressing interferon-gamma) in metastatic melanoma patients. Cancer Immunol Immunother. 2015 Jul;64(7):805-15. doi: 10.1007/s00262-015-1691-7. Epub 2015 Apr 7.

    PubMed 25846669

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing autologous Melan-A/MART-1 specific CTL clones in people with Immunotherapy, 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 12 inclusion and 7 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 24 Jul 2008. 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 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?

Evaluate the efficacy of an adoptive immunotherapy specific for Melan-A/MART1 antigen in metastatic melanoma patients whose tumor express this antigen but also HLA-A2 (time frame: one year). 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 NCT00720031, 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 24 Jul 2008.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in