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

Primary Purpose

Melanoma

Status
Suspended
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
Melan-A analog peptide
Sponsored by
University of Lausanne Hospitals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Adoptive cell transfer, peptide vaccination, melanoma, immunosuppression and homeostatic proliferation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Multidisciplinary Oncology Center, University of Lausanne Hospitals

Outcomes

Primary Outcome Measures

Toxicity and feasibility

Secondary Outcome Measures

Immunomonitoring of the immune reconstitution period

Full Information

First Posted
September 8, 2005
Last Updated
September 8, 2005
Sponsor
University of Lausanne Hospitals
Collaborators
Fond'action contre le cancer, Barletta Foundation, NCCR (National Center of Competence in Resaerch, Switzerland)
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1. Study Identification

Unique Protocol Identification Number
NCT00160992
Brief Title
Adoptive Cell Transfer Combined With Peptide Vaccination in Transiently Immunosuppressed Melanoma Patients
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 Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Suspended
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Lausanne Hospitals
Collaborators
Fond'action contre le cancer, Barletta Foundation, NCCR (National Center of Competence in Resaerch, Switzerland)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Adoptive cell transfer, peptide vaccination, melanoma, immunosuppression and homeostatic proliferation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Melan-A analog peptide
Primary Outcome Measure Information:
Title
Toxicity and feasibility
Secondary Outcome Measure Information:
Title
Immunomonitoring of the immune reconstitution period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Verena Voelter, MD
Organizational Affiliation
Multidisciplinary Oncology Center, University of Lausanne Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Multidisciplinary Oncology Center, University of Lausanne Hospitals
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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