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

Nantes University Hospital (NUH)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Immunotherapy

Treatments: Biological: autologous Melan-A/MART-1 specific CTL clones

Study type: Interventional

Funder types: Other

Identifiers

NCT00720031

BRD 98/9-C

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)