Know Cancer

forgot password

Immunization of Disease-Free Melanoma Patients With Different HLA-A2 Peptides

Phase 1/Phase 2
18 Years
Not Enrolling

Thank you

Trial Information

Immunization of Disease-Free Melanoma Patients With Different HLA-A2 Peptides

Open-label single center study. Patients will be divided in four groups of 7. The patients
will be entered sequentially at the time they present in clinic, and randomized in one of
the four groups.

The first group of patients will receive a dose of 300 µg of each of the MAGE-1.A2,
MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2, NA17.A2, Tyrosinase.A2 and NY-ESO-1.A2
peptides without adjuvant. The peptides will be mixed together and administered by
intradermal and superficial subcutaneous injections at two sites every three weeks on 5
occasions (3 months).

The second group of patients will receive on 5 occasions a vaccine containing the same 8
peptides mixed together but emulsified in 1 ml of Montanide ISA51. This vaccine will be also
administered by intradermal and subcutaneous injections every three weeks.

The third cohort of patients will receive at 3 weeks-interval on 5 occasions the mix of 8
peptides and 500 µg of IMP321. These two injections will be done at the same site, first
adjuvant IMP321 then the peptides.

The last seven patients will receive as vaccine the same mix of peptides emulsified with
Montanide ISA 51 VG and IMP321 injected with the same procedure as cohort 3. These vaccines
will be administrated every 3 weeks on 5 occasions by intradermal and superficial
subcutaneous injections.

Blood samples will be obtained from a buffy-coat at weeks 1 and 16. PBL collected at
baseline (day 1) and at week 16 will be tested to determine whether a specific CTL response,
defined as a 10-times or more increase in CTL frequency, occurred.

For the patients with an anti-vaccine lymphocyte response, 100 ml of blood will be collected
every three months in order to monitor their immune response. If a decrease in CTL frequency
by a factor 10 is observed, the patients will be revaccinated three times at three weeks
interval with the peptide(s) against which he developed an immune response mixed with the
adjuvant he already received.

The disease status will be assessed at study entry and thereafter every 3 months during one
year. At any time, relapse will result in withdrawal of the patient from the trial.

Inclusion Criteria:

Histologically proven cutaneous melanoma.

Patient's melanoma must be in one of the following AJCC stages :

only primary tumor : T3b-T4, N0, M0. regional lymph node metastasis and/or in-transit
metastasis, no distant metastasis (any T, N1-N3, M0) that has been removed.

Any distant metastasis that has been removed (M1) HLA-A2 positive. Patients with previous
regional metastatic disease must have one of their resected lesions analyzed by RT-PCR to
determine expression of genes MAGE-1, MAGE-3, MAGE-4, MAGE-10, MAGE-C2, NA17, Tyrosinase
or NY-ESO-1. However, expression of these genes by the tumor is not required to enter the

Absence of detectable melanoma lesions. WHO/ECOG performance status of 1 or less
(Karnofsky scale ≥ 70%).

The following laboratory results:

Hemoglobin ≥ 10 g/dl; Neutrophils ≥ 1,500/µl; Lymphocytes ≥ 700/µl; Platelets ≥
100,000/µl; Serum creatinin ≤ 2.0 mg/dl; Serum bilirubin ≤ 2.0 mg/dl; LDH within normal
institutional limits.

Age > 18 years. Able to give written informed consent.

Exclusion Criteria:

Clinically significant heart disease (NYHA Class III or IV). Other serious illnesses, e.g.
serious infections requiring antibiotics, bleeding disorders, a second active malignancy,
except basal cell carcinoma or in situ carcinoma of the uterine cervix.

Active immunodeficiency disease or autoimmune disease. Positive serology for HIV (human
immunodeficiency virus) or HCV (hepatitis C virus). Serum hepatitis B antigen (HBsAg) must
be negative.

More than one line of previous chemotherapy, or immunotherapy for the melanoma. Previous
vaccination with one of the antigen present in the vaccine. Treatment with steroids or
major immunosuppressive drugs within 4 weeks before study entry. Topical or inhalational
steroids are permitted.

Participation in any other clinical trial involving another investigational agent within 4
weeks prior to enrollment.

Pregnancy or lactation. Women of childbearing potential not using a medically acceptable
means of contraception.

Psychiatric or addictive disorders that may compromise the ability to give informed

Lack of availability of the patient for immunological and clinical follow-up assessment.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary: Determination of the cytolytic T lymphocyte response in the different arms.; Toxicity of the combination peptide and immunological adjuvants

Safety Issue:


Principal Investigator

Jean-François Baurain, M.D, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cliniques universitaires Saint-Luc


Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Study ID:

LUC 05-003



Start Date:

August 2006

Completion Date:

August 2009

Related Keywords:

  • Melanoma
  • immunotherapy
  • adjuvants
  • IMP321
  • Montanide ISA51 VG
  • tumor-specific peptides
  • Melanoma