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

This study has been completed.
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00720031
First received: July 18, 2008
Last updated: July 22, 2008
Last verified: July 2008
History of Changes

July 18, 2008
July 22, 2008
November 2000
May 2008   (final data collection date for 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 ] [ Designated as safety issue: No ]
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, ICAM-1 and LFA-3 molecules. [ Time Frame: one year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00720031 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Evaluate whether infused T cell clones transfer a specific immunity. [ Time Frame: J56 after treatment ] [ Designated as safety issue: No ]
  • evaluate infused Melan-A/MART1 reactive T cell clones tolerance [ Time Frame: one year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Evaluate whether infused T cell clones transfer a specific immunity. [ Time Frame: J56 after treatment ] [ Designated as safety issue: No ]
  • evaluate infused Melan-A/MART1 reactive T cell clones tolerance, in conjunction to IFN-a. [ Time Frame: one year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Treatment of Metastatic Melanoma With Autologous Melan-A/MART-1 Specific CTL Clones
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.
Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Immunotherapy
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
May 2008
May 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00720031
BRD 98/9-C
No
general director, Nantes University Hospital
Nantes University Hospital
Not Provided
Principal Investigator: Brigitte DRENO, PhD Nantes University Hospital
Nantes University Hospital
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP