Know Cancer

or
forgot password

Phase I Study of in Vivo Expansion of Melan-A/MART-1 Antigen-Specific CD8 T Lymphocytes Following Transient Immunosuppression in Patients With Advanced Melanoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Melanoma

Thank you

Trial Information

Phase I Study of in Vivo Expansion of Melan-A/MART-1 Antigen-Specific CD8 T Lymphocytes Following Transient Immunosuppression in Patients With Advanced Melanoma


Patients who have previously been vaccinated with Melan-A/MART-1 peptide are eligible. Whole
PBMC's containing Melan-A specific CD8+ lymphocytes are collected via lymphocytapheresis and
freezed. Lymphodepleting chemotherapy consists of 2 days of Busulfan 2mg/kg at days -7,-6,
followed by Fludarabine 30mg/m2 at days -5,-4,-3. At day 0, whole untreated PBMC's are
reinfused to the patient and vaccination with Melan-A analog peptide is restarted and
repeated every 4 weeks. Immunomonitoring with detailed FACS analysis using tetramers is
performed at day 0,8,15,30, and then monthly. The aim is to boost Melan-A specific CD8 T
cells in vivo during homeostatic proliferation after lymphodepletion and antigen driven
proliferation due to peptide vaccination.


Inclusion Criteria:



- Stage IV melanoma

- tumor expressing Melan-A

- patient of HLA-A2 subtype

- Detectable immune response after peptide vaccination with Melan-A

- Disease progression during peptide vaccination

Exclusion Criteria:

- Cerebral metastases

- rapidly progressive disease, that necessitates systemic chemotherapy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Toxicity and feasibility

Principal Investigator

Verena Voelter, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Multidisciplinary Oncology Center, University of Lausanne Hospitals

Authority:

Switzerland: Swissmedic

Study ID:

CePO-ITA-01

NCT ID:

NCT00160992

Start Date:

July 2004

Completion Date:

August 2005

Related Keywords:

  • Melanoma
  • Adoptive cell transfer
  • peptide vaccination
  • melanoma
  • immunosuppression and homeostatic proliferation
  • Melanoma

Name

Location