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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Immunotherapy

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Brigitte DRENO, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Nantes University Hospital

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

BRD 98/9-C

NCT ID:

NCT00720031

Start Date:

November 2000

Completion Date:

May 2008

Related Keywords:

  • Immunotherapy
  • 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.
  • Melanoma

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