COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

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. Identifier: NCT00160992
Recruitment Status : Suspended
First Posted : September 12, 2005
Last Update Posted : September 12, 2005
Fond'action contre le cancer
Barletta Foundation
NCCR (National Center of Competence in Resaerch, Switzerland)
Information provided by:
University of Lausanne Hospitals

Brief Summary:
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 or disease Intervention/treatment Phase
Melanoma Biological: Melan-A analog peptide Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 6 participants
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
Study Start Date : July 2004
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Primary Outcome Measures :
  1. Toxicity and feasibility

Secondary Outcome Measures :
  1. Immunomonitoring of the immune reconstitution period

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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 identifier (NCT number): NCT00160992

Layout table for location information
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)
Layout table for investigator information
Principal Investigator: Verena Voelter, MD Multidisciplinary Oncology Center, University of Lausanne Hospitals
Layout table for additonal information Identifier: NCT00160992    
Other Study ID Numbers: CePO-ITA-01
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: September 12, 2005
Last Verified: September 2005
Keywords provided by University of Lausanne Hospitals:
Adoptive cell transfer
peptide vaccination
immunosuppression and homeostatic proliferation
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas