NCT00160992

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2004

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

September 12, 2005

Status Verified

September 1, 2005

First QC Date

September 8, 2005

Last Update Submit

September 8, 2005

Conditions

Melanoma

Keywords

Adoptive cell transferpeptide vaccinationmelanomaimmunosuppression and homeostatic proliferation

Outcome Measures

Primary Outcomes (1)

  • Toxicity and feasibility

Secondary Outcomes (1)

  • Immunomonitoring of the immune reconstitution period

Interventions

Melan-A analog peptideBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Cerebral metastases
  • rapidly progressive disease, that necessitates systemic chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multidisciplinary Oncology Center, University of Lausanne Hospitals

Lausanne, 1011, Switzerland

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Verena Voelter, MD

    Multidisciplinary Oncology Center, University of Lausanne Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

July 1, 2004

Study Completion

August 1, 2005

Last Updated

September 12, 2005

Record last verified: 2005-09

Locations

CH(1)