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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00145145
Recruitment Status : Terminated (Poor Accrual)
First Posted : September 5, 2005
Last Update Posted : August 22, 2007
Information provided by:
Ludwig Institute for Cancer Research

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Malignant Melanoma Biological: MAGE-3.A1 peptide and CpG 7909 Phase 1 Phase 2

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Immunization With the MAGE-3.A1 Peptide Mixed With the Immunological Adjuvant CpG 7909 in Patients With Metastatic Melanoma
Study Start Date : January 2005
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Primary Outcome Measures :
  1. To determine whether immunization with the MAGE-3.A1 peptide mixed with CpG 7909 results in a detectable cytolytic T cell (CTL) response.

Secondary Outcome Measures :
  1. To analyze the toxicity of these immunizations.
  2. To determine the clinical effectiveness of these immunizations in the patients with measurable disease.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically proven cutaneous melanoma, or clear cell sarcoma, which is considered as a subtype of melanoma.
  2. Melanoma must be at one of the following AJCC 2002 stages:

    • Regional metastatic disease (any T; N2b, N2c or N3; M0).
    • Distant metastatic disease (any T; any N; M1a, M1b or M1c), except brain or leptomeningeal localizations, and except elevated LDH.
  3. Patients must be HLA-A1.
  4. Melanoma must express the MAGE-3 gene, as determined by RT-PCR.
  5. Presence of at least one measurable or non-measurable tumor lesion, excluding leptomeningeal metastasis (see Section 7.3).
  6. Expected survival of at least 3 months.
  7. Karnofsky performance scale ≥70 or WHO performance status of 0 or 1.
  8. Within the last 4 weeks prior to study day 1, vital laboratory parameters should be within normal range, except for the following laboratory parameters, which must be within the ranges specified:

    Lab Parameter Range

    • Hemoglobin ≥ 10 g/dl or ≥ 6,25 mmol/l
    • Granulocytes ≥ 1,500/µl
    • Lymphocytes ≥ 700/µl
    • Platelets ≥ 100,000/µl
    • Serum creatinin ≤ 2.0 mg/dl or ≤ 177 mmol/l
    • Serum bilirubin ≤ 2.0 mg/dl or ≤ 34.2 mmol/l
    • ASAT and ALAT ≤ 2 x the normal upper limits
    • LDH ≤ the normal upper limit.
  9. Viral tests:

    • HIV (human immunodeficiency virus): negative antibodies.
    • HBV (hepatitis B virus): negative antigens; antibodies may be positive.
    • HCV (hepatitis C virus): negative antibodies.
  10. Age ≥ 18 years
  11. Able and willing to give valid written informed consent.

Exclusion Criteria:

  1. Previous treatment with more than one regimen of systemic chemotherapy, combined or not with non-specific immunotherapy such as interferon alpha or interleukins. Chemoimmunotherapy or radiotherapy must be stopped within the preceding 4 weeks (6 weeks for nitrosoureas and mitomycin C).
  2. Previous treatment with a vaccine known or likely to contain the MAGE-3.A1 antigen, unless there is evidence that no CTL response against this antigen was induced by the vaccine.
  3. Clinically significant heart disease (NYHA Class III or IV) i.e. NYHA class 3 congestive heart failure; myocardial infarction within the past six months; unstable angina; coronary angioplasty within the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias).
  4. Active immunodeficiency or autoimmune disease. Vitiligo is not an exclusion criterion.
  5. Other serious acute or chronic illnesses, e.g. active infections requiring antibiotics, bleeding disorders, or other conditions requiring concurrent medications not allowed during this study.
  6. Other malignancy within 3 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ.
  7. Lack of availability for immunological and clinical follow-up assessments.
  8. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
  9. Pregnancy or breastfeeding.
  10. Women of childbearing potential: Refusal or inability to use effective means of contraception.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00145145

Cliniques Universitaires Saint-Luc (UCL)
Brussels, Belgium, B-1200
Ludwig Institute for Cancer Research
Brussels, Belgium, B-1200
Sponsors and Collaborators
Ludwig Institute for Cancer Research
Study Chair: Nicolas van Baren, MD Ludwig Institute for Cancer Research
Study Director: Thierry Boon, PhD Ludwig Institute for Cancer Research

Additional Information:
Publications: Identifier: NCT00145145     History of Changes
Other Study ID Numbers: LUD2002-001
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: August 22, 2007
Last Verified: August 2007

Keywords provided by Ludwig Institute for Cancer Research:

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Immunologic Factors
Physiological Effects of Drugs