Status:
COMPLETED
Safety Study of a Dendritic Cell-based Cancer Vaccine in Melanoma
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
Etablissement Français du Sang
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Melanoma
Tumor Vaccines
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The primary objective of this study is to evaluate the safety and tolerability of multiple sub-cutaneous injections of GeniusVac-Mel4, a dendritic cell-based cancer vaccine, in patients with melanoma....
Detailed Description
GeniusVac-Mel4 is a drug product composed of an irradiated allogeneic plasmacytoid dendritic cell (PDC) line loaded with 4 melanoma peptides derived from Melan-A, gp100, Tyrosinase or Mage-A3. This ce...
Eligibility Criteria
Inclusion
- 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
- Positive serology for HCV, HTLV, HIV, active hepatitis
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2017
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01863108
Start Date
June 1 2013
End Date
March 23 2017
Last Update
August 13 2025
Active Locations (1)
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1
Grenoble University Hospital
Grenoble, France, 38000