Adoptive Cell Transfer Combined With Peptide Vaccination in Transiently Immunosuppressed Melanoma Patients
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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 |
- Toxicity and feasibility
- Immunomonitoring of the immune reconstitution period
| Estimated Enrollment: | 6 |
| Study Start Date: | July 2004 |
| Estimated Study Completion Date: | August 2005 |
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 |
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| Switzerland | |
| Multidisciplinary Oncology Center, University of Lausanne Hospitals | |
| Lausanne, Switzerland, 1011 | |
| 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 Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
ClinicalTrials.gov processed this record on May 16, 2013