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

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00160992
• Other study ID #: CePO-ITA-01
• Status: Suspended
• Phase: Phase 1
• First received: September 8, 2005
• Last updated: September 8, 2005
• Start date: July 2004
• Est. completion date: August 2005

Study information

• Verified date: September 2005
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 6
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

Intervention

Biological:
• Melan-A analog peptide

Locations

Country	Name	City	State
Switzerland	Multidisciplinary Oncology Center, University of Lausanne Hospitals	Lausanne

Sponsors (4)

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

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity and feasibility
Secondary	Immunomonitoring of the immune reconstitution period