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

NCT ID: NCT00160992

Last Updated: 2005-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2005-08-31

Brief Summary

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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

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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.

Conditions

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Melanoma

Keywords

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Adoptive cell transfer peptide vaccination melanoma immunosuppression and homeostatic proliferation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Melan-A analog peptide

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fond'action contre le cancer

UNKNOWN

Sponsor Role collaborator

Barletta Foundation

OTHER

Sponsor Role collaborator

NCCR (National Center of Competence in Resaerch, Switzerland)

NETWORK

Sponsor Role collaborator

University of Lausanne Hospitals

OTHER

Sponsor Role lead

Principal Investigators

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Verena Voelter, MD

Role: PRINCIPAL_INVESTIGATOR

Multidisciplinary Oncology Center, University of Lausanne Hospitals

Locations

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Multidisciplinary Oncology Center, University of Lausanne Hospitals

Lausanne, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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CePO-ITA-01

Identifier Type: -

Identifier Source: org_study_id