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Completed

NCT Number: NCT00720031

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

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.

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Key information

Conditions

Immunotherapy Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Nantes University Hopspital

Nantes, Pays de la Loire Region, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

autologous Melan-A/MART-1 specific CTL clones

Biological

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.

Primary outcomes

  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

    Time frame: one year

Secondary outcomes

  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

    Time frame: after treatment

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

    Time frame: J56 after treatment

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

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Important dates

Study start
2000
Primary completion
2008
Study completion
2008
First posted
Jul 22, 2008
Registry last updated
Jul 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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