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

This study has suspended participant recruitment.
Sponsor:
Collaborators:
Fond'action contre le cancer
Barletta Foundation
NCCR (National Center of Competence in Resaerch, Switzerland)
Information provided by:
University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT00160992
First received: September 8, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160992

Locations
Switzerland
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)
Investigators
Principal Investigator: Verena Voelter, MD Multidisciplinary Oncology Center, University of Lausanne Hospitals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00160992     History of Changes
Other Study ID Numbers: CePO-ITA-01
Study First Received: September 8, 2005
Last Updated: September 8, 2005
Health Authority: Switzerland: Swissmedic

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

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on October 22, 2014