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

Phase 1

Completed

• Conditions: Immunotherapy

• Registration Number: NCT00720031
• Lead Sponsor: Nantes University Hospital

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-11
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2008-07
• Study First Submitted: 2008-07-18
• Study First Submitted QC: 2008-07-21
• Study First Posted: 2008-07-22
• Last Update Submitted: 2008-07-22
• Last Update Posted: 2008-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• 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.

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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	one year

Secondary Outcome Measures

Name	Time	Method
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	after treatment
Evaluate whether infused T cell clones transfer a specific immunity.	J56 after treatment
evaluate infused Melan-A/MART1 reactive T cell clones tolerance	one year

Trial Locations

Locations (1)

Nantes University Hopspital; 🇫🇷 Nantes, Pays de la Loire, France