Immunotherapy of Melanoma Patients

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

Switzerland

Study Type

Interventional

Intervention

Melan-A analog peptide

FluMa peptide

Mage-A10 peptide

SB AS-2 adjuvant

Montanide adjuvant

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Immunotherapy, Vaccination, Melanoma, Melan-A/Mart-1 peptide, Flu peptide, Mage-A10 peptide, SB AS-2 adjuvant, Montanide adjuvant

Eligibility Criteria

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

Inclusion Criteria: Patients with microscopically detectable lymph node metastases Positive detection of the Melan-A gene +/- MAGE-10 in positive sentinel node or primary tumor tissue by polymerase chain reaction (PCR) analysis of mRNA and/or by immunohistochemistry using monoclonal antibodies Human leukocyte antigen-A2 (HLA-A2) positive Exclusion Criteria: Previous splenectomy or radiotherapy to the spleen Treatment with systemic antihistamines, corticosteroids, or non-steroidal anti-inflammatory drugs (except occasional or low dose non-steroidal anti-inflammatory drugs such as 100 mg aspirin/day) within 4 weeks of entry into the study Heart disease (New York Heart Association [NYHA] Class III or IV) Serious illness, e.g. active infections requiring antibiotics, bleeding disorders or other diseases considered by the investigator to have potential for interfering with obtaining accurate results from this study

Sites / Locations

Ludwig Institute for Cancer Research + Multidisciplinary Oncology Center at the Centre Hospitalier Universitaire Vaudois

Outcomes

Primary Outcome Measures

Melan-A, Flu and Mage specific CD8+ T-cell reactivity obtained from different body sites (vaccine site draining lymph node, other lymph node) will be measured by Tetramers and Elispot assays

Secondary Outcome Measures

Safety and toxicity of antigenic peptides administered with high dose adjuvant will be assessed according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) scale

Full Information

NCT ID

NCT00112216

First Posted

May 31, 2005

Last Updated

April 23, 2013

Sponsor

Centre Hospitalier Universitaire Vaudois

1. Study Identification

Unique Protocol Identification Number

NCT00112216

Brief Title

Immunotherapy of Melanoma Patients

Official Title

Specific Immunotherapy of Skin Melanoma Patients With Antigenic Peptides and Immunological Analysis of the Vaccine Site Sentinel Lymph Node

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Completed

Study Start Date

May 1999 (undefined)

Primary Completion Date

June 2007 (Actual)

Study Completion Date

June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Centre Hospitalier Universitaire Vaudois

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

The purpose of this study is to test whether vaccination with antigenic peptides induces an immune response in the vaccine site sentinel lymph node of patients with microscopically detectable lymph node melanoma metastases.

Detailed Description

The study is designed for patients with skin melanoma and lymph node micrometastasis previously diagnosed by a sentinel node procedure. As a result of their diagnosis, the patients are scheduled for lymph node dissection. Before this is done, patients are vaccinated with antigenic peptides. The peptides are mixed with the adjuvant SB AS-2 or Montanide and injected in a lower limb not affected by the disease. The skin site of vaccine injection is marked with a permanent pen where, two weeks later, patent blue and 99technetium is injected. These markers allow one to locate the vaccine site sentinel node (VSSN) which will be removed during the lymph node dissection at the diseased limb. The aim of the study is to test whether the vaccine has induced an immune response in the lymph node that drains the vaccine site.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma

Keywords

Immunotherapy, Vaccination, Melanoma, Melan-A/Mart-1 peptide, Flu peptide, Mage-A10 peptide, SB AS-2 adjuvant, Montanide adjuvant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

Melan-A analog peptide

Intervention Type

Biological

Intervention Name(s)

FluMa peptide

Intervention Type

Biological

Intervention Name(s)

Mage-A10 peptide

Intervention Type

Biological

Intervention Name(s)

SB AS-2 adjuvant

Intervention Type

Biological

Intervention Name(s)

Montanide adjuvant

Primary Outcome Measure Information:

Title

Melan-A, Flu and Mage specific CD8+ T-cell reactivity obtained from different body sites (vaccine site draining lymph node, other lymph node) will be measured by Tetramers and Elispot assays

Secondary Outcome Measure Information:

Title

Safety and toxicity of antigenic peptides administered with high dose adjuvant will be assessed according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) scale

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Patients with microscopically detectable lymph node metastases Positive detection of the Melan-A gene +/- MAGE-10 in positive sentinel node or primary tumor tissue by polymerase chain reaction (PCR) analysis of mRNA and/or by immunohistochemistry using monoclonal antibodies Human leukocyte antigen-A2 (HLA-A2) positive Exclusion Criteria: Previous splenectomy or radiotherapy to the spleen Treatment with systemic antihistamines, corticosteroids, or non-steroidal anti-inflammatory drugs (except occasional or low dose non-steroidal anti-inflammatory drugs such as 100 mg aspirin/day) within 4 weeks of entry into the study Heart disease (New York Heart Association [NYHA] Class III or IV) Serious illness, e.g. active infections requiring antibiotics, bleeding disorders or other diseases considered by the investigator to have potential for interfering with obtaining accurate results from this study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Speiser, MD

Organizational Affiliation

Ludwig Institute for Cancer Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ludwig Institute for Cancer Research + Multidisciplinary Oncology Center at the Centre Hospitalier Universitaire Vaudois

City

Lausanne

State/Province

Vaud

ZIP/Postal Code

1011

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

12576434

Citation

Ayyoub M, Zippelius A, Pittet MJ, Rimoldi D, Valmori D, Cerottini JC, Romero P, Lejeune F, Lienard D, Speiser DE. Activation of human melanoma reactive CD8+ T cells by vaccination with an immunogenic peptide analog derived from Melan-A/melanoma antigen recognized by T cells-1. Clin Cancer Res. 2003 Feb;9(2):669-77.

Results Reference

result

Melanoma

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial