Dose-escalation Study to Assess the Safety and Tolerability of Sub-cutaneous Injections of GeniusVac-Mel4 in Patients With Melanoma
18 Years
N/A
Both
Melanoma, Tumor Vaccines, Effects of Immunotherapy
Trial Information
Dose-escalation Study to Assess the Safety and Tolerability of Sub-cutaneous Injections of GeniusVac-Mel4 in Patients With Melanoma
GeniusVac-Mel4 corresponds to an irradiated allogeneic plasmacytoid dendritic cell line
loaded with 4 melanoma peptides. This cell line is HLA-A*0201, a phenotype found in 40% of
the European population. This approach exploits the pDC line high capacity of boosting
anti-tumor cytotoxic response against melanoma antigens in HLA-A*201 melanoma patients. In
the preclinical studies, its efficacy was shown in melanoma in vivo in humanized mice and ex
vivo from the PBMC (peripheral blood mononuclear cells) of patients.
It is planned to include patients in three dose-escalating groups (4, 20, 60 millions of
GeniusVac-Mel4 cells). 3 patients will be recruited in each dose group of the trial.
Inclusion Criteria:
- Patients with histologically confirmed metastatic melanoma (at stage IIIC or stage IV
under the AJCC 2009 classification not surgically resectable.
- Patients who do not respond to at least one line of systemic treatment
- Male and female (with β-HCG negative test)
- Patients HLA-A*0201
- Age > 18 years
- Blood parameters (Hemoglobin ≥ 10g/dl, Leucocytes ≥ 4000/μl,Lymphocytes ≥ 1000/μl,
Platelets ≥100.000/μl, creatinin ≤ 2.0mg/dl, bilirubin ≤ 2.0mg/dl, ASAT and ALAT ≤
2.5 fold the upper normal level)
- OMS performance score < 3
- Informed written consent.
Exclusion Criteria:
- Positive serology for HCV, HBV, HTLV, HIV
- Protected persons according to French regulations articles L1121-5 to L1121-8 (Public
Health Code)
- Non-pregnant women without effective contraception
- Any serious acute or chronic illness, for example: active infection, coagulation
disorder.
- Presence of a second cancer in the 5 years preceding inclusion into the study with
the exception of in situ cervical carcinoma or a cutaneous carcinoma or other
melanoma.
- Intercurrent disease requiring corticosteroids.
- Any active autoimmune disease including insulin dependent diabetes mellitus. Vitiligo
or autoimmune thyroid disease are not criteria for exclusion.
- Autoimmune eye disease.
- Evidence of immunosuppression for any reason
- Primary ocular melanoma
- Chemotherapy, immunotherapy or radiotherapy in the 4 weeks preceding inclusion (6
weeks in the case of nitroso-urea and mitomycin C).
- Treatment with drugs under development within 4 weeks.
- Cerebral metastases metastasis with the exception of: known metastasis previously
treated by surgery or stereotactic radio-surgery, AND Cerebral metastasis, if still
present, must be stable for at least 90 days before inclusion and documented with two
consecutive MRI or scanner with contrast media, AND, asymptomatic
- Existence of any surgical or medical condition which, in the judgment of the
Investigator, might interfere with this study.
- Patients who are not willing to comply with the provisions of this protocol.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Tolerability and safety of a multiple sub-cutaneous injections of GeniusVac-Mel4.
Outcome Description:
Safety and tolerance will be clone monitored by performing clinical laboratory tests, assessments of vital signs, full clinical examination, occurrence of adverse events.
Outcome Time Frame:
1 year
Safety Issue:
Yes
Principal Investigator
Joel Plumas, PhD
Investigator Role:
Study Director
Investigator Affiliation:
Etablissement Français du Sang
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
DCIC 11 19
NCT ID:
NCT01863108
Start Date:
May 2013
Completion Date:
November 2016
Related Keywords:
- Melanoma
- Tumor Vaccines
- Effects of Immunotherapy
- Melanoma
- Immunotherapy
- Dermatology
- cancer vaccine
- plasmacytoid dendritic cell line
- allogeneic
- Melanoma
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