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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

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

NCT ID

NCT00160992

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)

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

Eligibility Criteria

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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