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

This study has been terminated.
(Poor Accrual)
Sponsor:
Information provided by:
Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier:
NCT00145145
First received: September 1, 2005
Last updated: August 21, 2007
Last verified: August 2007
  Purpose

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 Intervention Phase
Malignant Melanoma
Biological: MAGE-3.A1 peptide and CpG 7909
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ludwig Institute for Cancer Research:

Primary Outcome Measures:
  • 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:
  • To analyze the toxicity of these immunizations.
  • To determine the clinical effectiveness of these immunizations in the patients with measurable disease.

Estimated Enrollment: 14
Study Start Date: January 2005
Study Completion Date: April 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145145

Locations
Belgium
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
Investigators
Study Chair: Nicolas van Baren, MD Ludwig Institute for Cancer Research
Study Director: Thierry Boon, PhD Ludwig Institute for Cancer Research
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00145145     History of Changes
Other Study ID Numbers: LUD2002-001
Study First Received: September 1, 2005
Last Updated: August 21, 2007
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Ludwig Institute for Cancer Research:
Melanoma
Vaccine
Peptide
MAGE
CpG

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

ClinicalTrials.gov processed this record on July 23, 2014