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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00720031
Recruitment Status : Completed
First Posted : July 22, 2008
Last Update Posted : July 24, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Immunotherapy Biological: autologous Melan-A/MART-1 specific CTL clones Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Metastatic Melanoma With Autologous Melan-A/MART-1 Specific CTL Clones
Study Start Date : November 2000
Primary Completion Date : May 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources


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

    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 Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00720031


Locations
France
Nantes University Hopspital
Nantes, Pays de la Loire, France, 44093
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Brigitte DRENO, PhD Nantes University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: general director, Nantes University Hospital
ClinicalTrials.gov Identifier: NCT00720031     History of Changes
Other Study ID Numbers: BRD 98/9-C
First Posted: July 22, 2008    Key Record Dates
Last Update Posted: July 24, 2008
Last Verified: July 2008

Keywords provided by Nantes University Hospital:
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.

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas