Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Vaccines

Adjuvants, Immunologic

Patients were vaccinated every two weeks on six occasions. On each vaccination day, the MAGE-3.A1 peptide (300 mcg) mixed with CpG 7909 (5 mg) was administered twice intradermally (10% of the dose each) and twice subcutaneously (40% of the dose each) in the arms and thighs.

MAGE-3.A1 peptide and CpG 7909

Nicolas van Baren, MD

Thierry Boon, PhD

The purposes of this study are to determine whether immunization with the MAGE-3.A1 peptide mixed with CpG 7909 results in a detectable immune response; to determine the safety of this vaccine and to document the tumor response to the vaccine.

Patients will be vaccinated every two weeks on six occasions. On each vaccination day, the MAGE-3.A1 peptide (300 µg) mixed with CpG 7909 (5 mg) will be administered twice intradermally (10% of the dose each) and twice subcutaneously (40% of the dose each) in the arms and thighs.

Tumor staging will be performed before inclusion and at week 13. PBL collections will be performed before starting the treatment, and at weeks 3, 7 and 13. They will provide the T lymphocytes for the immunological analysis.

Additional cycles of immunization will be proposed to patients without tumor progression requiring another treatment. A second cycle of 3 injections at 6-week intervals will be started at week 17 with the same vaccine, followed by a third cycle of 12 injections at 3-month intervals starting at month 11. At any time, progression of the disease necessitating any treatment not allowed during the study, will result in study withdrawal.

Immunization With the MAGE-3.A1 Peptide Mixed With the Adjuvant CpG 7909 in Patients With Metastatic Melanoma

Phase I/II Study of Immunization With the MAGE-3.A1 Peptide Mixed With the Immunological Adjuvant CpG 7909 in Patients With Metastatic Melanoma

Blood samples were collected prior to treatment and in weeks 3, 7, and 13. Specific CTL responses directed against the MAGE-3.A1 antigen were to be assessed by using restimulation in vitro, followed by staining with the A1/MAGE-3 tetramer and cloning of the tetramer-positive lymphocytes (MLPC/tetramer/cloning assay).

All adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale, version 3.0.

DLT was defined as:

* Any Grade 3 hematological or non-hematological toxicity other than skin or flu-like symptoms.
* Any Grade 4 toxicity. To be dose-limiting, an adverse event must be definitely, probably, or possibly related to the administration of MAGE-3.A1 peptide mixed with CpG 7909.

Computed tomography (CT) scans were performed at screening, and at week 13. Response was assessed using RECIST version 1.0 (Therasse et al, J Natl Cancer Inst 2000; 92:205-16). Per RECIST, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions (no evaluable disease); partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria.

Ludwig Institute for Cancer Research

All Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent until end of study were documented. Toxicity was reported according to the Common Terminology Criteria for Adverse Events (CTCAE) Scale of the National Cancer Institute, version 3.0.

MAGE-3.A1 Peptide Mixed With CpG 7909

Age, Categorical

Sex: Female, Male

Belgium

Region of Enrollment

The one patient who was entered into the study.

Jonathan Skipper PhD

The cytolytic T lymphocyte (CTL) response directed against the MAGE-3.A1 vaccine antigen was not analyzed due to the premature closing of this trial after only one patient was treated.

Number of Patients With a Detectable Cytolytic T Lymphocyte (CTL) Response Following Immunization With the MAGE-3.A1 Peptide Mixed With CpG 7909.

The one patient who was entered into the study and received study treatment.

To Determine the Safety of the Treatment by Measuring the Number of Patients With Dose Limiting Toxicities (DLT)

The one patient who was entered into and treated in this study.

Spots Global Cancer Trial Database for cpg

Every month we try and update this database with for cpg cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cpg

Every month we try and update this database with for cpg cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cpg cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.