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Adoptive Cell Transfer Combined With Peptide Vaccination in Transiently Immunosuppressed Melanoma Patients

This study has suspended participant recruitment.
Fond'action contre le cancer
Barletta Foundation
NCCR (National Center of Competence in Resaerch, Switzerland)
Information provided by:
University of Lausanne Hospitals Identifier:
First received: September 8, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
Patients with advanced stage melanoma who underwent vaccination with the Melan-A/MART-1 peptide and who display detectable levels of Melan-A specific CD8+ T cells in peripheral blood are eligible for this trial. After collecting and freezing of these tumor specific T cells via apheresis, patients undergo a single cycle of immunosuppressive chemotherapy. 3 days after, cells are reinfused and peptide vaccination continued. The aim of this immunotherapy protocol is to boost tumor specific T cells during the immune recovery period in order to reinforce the patients' immune response against the tumor.

Condition Intervention Phase
Melanoma Biological: Melan-A analog peptide Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:
  • Toxicity and feasibility

Secondary Outcome Measures:
  • Immunomonitoring of the immune reconstitution period

Estimated Enrollment: 6
Study Start Date: July 2004
Estimated Study Completion Date: August 2005
Detailed Description:
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.

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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00160992

Multidisciplinary Oncology Center, University of Lausanne Hospitals
Lausanne, Switzerland, 1011
Sponsors and Collaborators
University of Lausanne Hospitals
Fond'action contre le cancer
Barletta Foundation
NCCR (National Center of Competence in Resaerch, Switzerland)
Principal Investigator: Verena Voelter, MD Multidisciplinary Oncology Center, University of Lausanne Hospitals
  More Information Identifier: NCT00160992     History of Changes
Other Study ID Numbers: CePO-ITA-01
Study First Received: September 8, 2005
Last Updated: September 8, 2005

Keywords provided by University of Lausanne Hospitals:
Adoptive cell transfer
peptide vaccination
immunosuppression and homeostatic proliferation

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas processed this record on August 17, 2017