Immunotherapy of HLA-A2 Positive Stage III/IV Melanoma Patients

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine whether vaccination with tumor antigenic peptides and both CpG and Montanide adjuvants can induce an immune response in melanoma patients and to assess the safety of this vaccination.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Immunotherapy of Stage III/IV Melanoma Patients

NCT00112242

Melanoma

COMPLETED PHASE1

Immunotherapy of HLA-A2 Positive Stage II-IV Melanoma Patients

NCT01308294

Melanoma

TERMINATED PHASE1/PHASE2

Immunotherapy of Melanoma Patients

NCT00112216

Melanoma

COMPLETED PHASE1

Immunization With 8 Peptides Mixed With CpG 7909 or Montanide ISA51 in Patients With Metastatic Cutaneous Melanoma

NCT00145158

Malignant Melanoma

TERMINATED PHASE1/PHASE2

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

NCT00160992

Melanoma

SUSPENDED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Immune therapy with tumor antigenic peptides is generally quite well tolerated. However, immune activation is often only weak or even undetectable, and clinical responses (supposedly corresponding to protective immunity) are unfortunately infrequent. Further progress is required to improve the vaccines, with the goal to increase the strength of immune activation.

The tumor antigenic peptides Melan-A/Mart-1 (EAA and ELA) and Tyrosinase (YMD) are combined with two drugs in this study, both of which are known to enhance immune responses: first, CpG 7909 oligodeoxynucleotides, and second, Montanide ISA-51.

* Group 1: vaccination with Melan-A analog peptide + CpG and Montanide adjuvants;
* Group 2: vaccination with Melan-A natural peptide + CpG and Montanide adjuvants;
* Group 3 : vaccination with Melan-A natural and Tyrosinase peptides + CpG and Montanide adjuvants;
* Group 4 : vaccination with Melan-A analog and Tyrosinase peptides + CpG and Montanide adjuvants.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Melanoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

group 1

Melan-A analog peptide + CpG + Montanide

Group Type EXPERIMENTAL

group 1

Intervention Type BIOLOGICAL

Melan-A analog peptide + CpG + Montanide

group 2

Melan-A natural peptide + CpG + Montanide

Group Type EXPERIMENTAL

group 2

Intervention Type BIOLOGICAL

Melan-A natural peptide + CpG + Montanide

group 3

Melan-A natural peptide + Tyrosinase YMD peptide + CpG + Montanide

Group Type EXPERIMENTAL

group 3

Intervention Type BIOLOGICAL

Melan-A natural peptide + Tyrosinase YMD peptide + CpG + Montanide

group 4

Melan-A analog peptide + Tyrosinase YMD peptide + CpG + Montanide

Group Type EXPERIMENTAL

group 4

Intervention Type BIOLOGICAL

Melan-A analog peptide + Tyrosinase YMD peptide + CpG + Montanide

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

group 1

Melan-A analog peptide + CpG + Montanide

Intervention Type BIOLOGICAL

group 2

Melan-A natural peptide + CpG + Montanide

Intervention Type BIOLOGICAL

group 3

Melan-A natural peptide + Tyrosinase YMD peptide + CpG + Montanide

Intervention Type BIOLOGICAL

group 4

Melan-A analog peptide + Tyrosinase YMD peptide + CpG + Montanide

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histologically confirmed stage III or stage IV melanoma
* Tumor expression of Melan-A +/- Tyrosinase
* Human leukocyte antigen-A2 (HLA-A2) positive

Exclusion Criteria

* Clinically significant heart disease
* Serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders or uncontrolled peptic ulcer, or seizure or central nervous system disorders
* History of immunodeficiency disease or autoimmune disease
* Coagulation or bleeding disorders

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No