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Phase I/II Study of Therapeutic Vaccination With Escalating Doses of Theravac®, a Proteinic Vector Targeting Dendritic Cells Coupled to a Melanoma Antigen, in Patients With Advanced Metastatic Melanoma.

Phase 1/Phase 2
18 Years
Open (Enrolling)

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Trial Information

Phase I/II Study of Therapeutic Vaccination With Escalating Doses of Theravac®, a Proteinic Vector Targeting Dendritic Cells Coupled to a Melanoma Antigen, in Patients With Advanced Metastatic Melanoma.

There are three treatment cohorts and the inclusion of patients in governed by the
dose-limiting toxicities in the previous cohort.

- the first three patients will receive a dose of 50 µg of Theravac®

- second cohort of three patients will receive a dose of 150 µg Theravac®

- the third cohort of three patients will receive a dose of 250 µg Theravac® and
eventually a total of 14 patients will complete the step with the highest dose.

All the patients will receive four immunizations every three weeks in two intradermal sites
and in two subcutaneous sites.

Inclusion Criteria:

1. Histologically proven cutaneous, uveal or mucosal melanoma.

2. Melanoma must be metastatic. The origin of the primary could be cutaneous, uveal or
mucosal and any metastatic stage is accepted, except if brain or leptomeningeal
localizations are present, or if plasma LDH are elevated more than 1.5 normal upper
values (see also below).

3. HLA-A2 positive.

4. The melanoma must express the tyrosinase gene (positive RT-PCR on a frozen pre-immune
tumor sample) (see Appendix B).

5. At least one measurable or non-measurable tumor lesion (see Section 8.1).

6. Expected survival of at least 3 months.

7. Karnofsky performance scale ≥70 or WHO performance status of 0 or 1 (see Appendix C).

8. 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
μmol/l Serum bilirubin ≤ 2.0 mg/dl or ≤ 34.2 μmol/l ASAT and ALAT ≤ 2 x the normal
upper limits LDH ≤ 1.5 x the normal upper limit.

9. Viral serology:

- 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 Tyrosinase.A2
epitope YMDGTMSQV.

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

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. Allergy to kanamycin (used in the preparation of the recombinant protein) or to any
other aminoglycoside antibiotic.

8. Lack of availability for immunological and clinical follow-up assessments.

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

10. Pregnancy or breastfeeding.

11. Women of childbearing potential: Refusal or inability to use effective means of

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To analyze the safety and toxicity of increasing doses of Theravac® in patients with advanced metastatic melanoma

Outcome Description:

The toxicity will be assess after the treatment (3 months) for the first three patients of each group.

Outcome Time Frame:

the first 3 months of treatment

Safety Issue:


Principal Investigator

Jean-François Baurain, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cliniques universitaires Saint-Luc, Centre du Cancer


Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

LUC 09-003



Start Date:

September 2010

Completion Date:

Related Keywords:

  • Melanoma
  • Metastatic Melanoma
  • Safety
  • Theravac vaccine
  • HLA-A2 typing
  • Tyrosinase.A2 gene expression
  • Melanoma