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

NCT00145145 | Terminated Phase 1 Results

• 1 other identifier: LUD2002-001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

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.

Conditions

Malignant Melanoma

Keywords

Melanoma; Vaccine; Peptide; MAGE; CpG

Outcome Measures

Primary Outcomes (1)

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

  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).

  Up to 12 weeks

Secondary Outcomes (2)

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

  up to 12 weeks

• To Determine the Clinical Effectiveness of the Treatment by Measuring Tumor Response in Patients With Measurable Disease.

  up to 12 weeks

Study Arms (1)

MAGE-3.A1 Peptide mixed with CpG 7909

EXPERIMENTAL

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.

Biological: MAGE-3.A1 peptide and CpG 7909

Interventions

MAGE-3.A1 peptide and CpG 7909 BIOLOGICAL

MAGE-3.A1 Peptide mixed with CpG 7909

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven cutaneous melanoma, or clear cell sarcoma, which is considered as a subtype of melanoma.
• 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.
• Patients must be HLA-A1.
• Melanoma must express the MAGE-3 gene, as determined by RT-PCR.
• Presence of at least one measurable or non-measurable tumor lesion, excluding leptomeningeal metastasis.
• Expected survival of at least 3 months.
• Karnofsky performance scale ≥70 or WHO performance status of 0 or 1.
• 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

You may not qualify if:

• 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).
• 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.
• Clinically significant heart disease 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).
• 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.
• Other malignancy within 3 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ.
• Lack of availability for immunological and clinical follow-up assessments.
• Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
• Pregnancy or breastfeeding.
• Women of childbearing potential: Refusal or inability to use effective means of contraception.

Sponsors & Collaborators

• Ludwig Institute for Cancer Research: lead

Study Sites (2)

Cliniques Universitaires Saint-Luc (UCL)

Brussels, B-1200, Belgium

Location

Ludwig Institute for Cancer Research

Brussels, B-1200, Belgium

Location

Related Publications (3)

• Marchand M, van Baren N, Weynants P, Brichard V, Dreno B, Tessier MH, Rankin E, Parmiani G, Arienti F, Humblet Y, Bourlond A, Vanwijck R, Lienard D, Beauduin M, Dietrich PY, Russo V, Kerger J, Masucci G, Jager E, De Greve J, Atzpodien J, Brasseur F, Coulie PG, van der Bruggen P, Boon T. Tumor regressions observed in patients with metastatic melanoma treated with an antigenic peptide encoded by gene MAGE-3 and presented by HLA-A1. Int J Cancer. 1999 Jan 18;80(2):219-30. doi: 10.1002/(sici)1097-0215(19990118)80:23.0.co;2-s.

  PMID: 9935203 BACKGROUND

• Germeau C, Ma W, Schiavetti F, Lurquin C, Henry E, Vigneron N, Brasseur F, Lethe B, De Plaen E, Velu T, Boon T, Coulie PG. High frequency of antitumor T cells in the blood of melanoma patients before and after vaccination with tumor antigens. J Exp Med. 2005 Jan 17;201(2):241-8. doi: 10.1084/jem.20041379.

  PMID: 15657293 BACKGROUND

• Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205.

  PMID: 10655437 BACKGROUND

MeSH Terms

Conditions

Melanoma

Interventions

ProMune

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Study terminated due to poor enrollment.

Results Point of Contact

• Title: Jonathan Skipper PhD
• Organization: Ludwig Institute for Cancer Research

jskipper@lcr.org

12124501539

Study Officials

• Nicolas van Baren, MD

  Ludwig Institute for Cancer Research

  STUDY CHAIR

• Thierry Boon, PhD

  Ludwig Institute for Cancer Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 5, 2005
• Study Start: January 12, 2005
• Primary Completion: April 7, 2005
• Study Completion: April 28, 2008
• Last Updated: October 7, 2022
• Results First Posted: July 21, 2021

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)