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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Active	Over 18	Other	LUC 05-003 NCT00365937

Trial Description

Summary

Open-label single center study. Patients will be divided in four groups of 7. Group 1: 8 melanoma-specific peptides in saline; Group 2: same mix of peptides + Montanide ISA51; Group 3: same mix of peptides + IMP321 500 µg; Group 4: same mix of peptides + IMP321 500 µg + Montanide ISA51. These vaccines will be administered every 3 weeks on 5 occasions by intradermal and superficial subcutaneous injections.

Further Study Information

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.

Eligibility Criteria

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 study. 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 consent.

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Cliniques Universitaires Saint-Luc

Jean-François Baurain, M.D, PhD

Principal Investigator

Jean-François Baurain, M.D., PhD		Ph: +32 2 764 54 70
		Email: baurain@onco.ucl.ac.be

Aline Gillain		Ph: +32 2 764 54 85
		Email: aline.gillain@onco.ucl.ac.be

Belgium
	Brussels
	Cliniques Universitaires Saint-Luc
		Jean-François Baurain, M.D., PhD	Ph: + 32 2 764 54 70
			Email: baurain@onco.ucl.ac.be

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00365937
Information obtained from ClinicalTrials.gov on May 13, 2009