Malignant melanoma stage IV M1c or better
Conditions
Interventions
Product Name: Dendritic cell vaccine
Product Code: DC
Pharmaceutical Form: Solution for injection
Sponsors
The Norwegian Radium Hospital, Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Histologically verified malignant melanoma with measurable (according to RECIST), unresectable metastases (Stage III or Stage IV M1a-c as defined by criteria of the AJCC Cancer Staging Manual, 6 th. Edition 2002). Patients with a melanoma of an unknown primary site are eligible •Preferably accessible tumor tissue with enough volume and quality for vaccine production (extraction of tumor mRNA) •Must be at least 18 years of age •Must be ambulatory with a ECOG performance status 0 or 1 •Life expectancy = 6 months •Negative MRI of the brain •Must have lab values as the following: ? ANC = 1.5 x 109/L ? Platelets = 100 x 109/L ? Hb = 9 g/dL (= 5.6 mmol/L) ? Creatinine = 140 µmol/L (1.6 mg/dL); if borderline, the creatinine clearance = 40 mL/min ? Bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •The patient suffers from an ocular- or mucous membrane melanoma •History of prior malignancy other than melanoma, with the exception of curatively treated basel cell or squamous cell carcinoma of the skin and cervix cancer stage 1B or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured •Active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune systems. PI shall make the final determination regarding appropriateness of enrolment •Autoimmune disease currently being treated with systemic steroids •Adverse reactions to vaccines such as anaphylaxis or other serious reactions •History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis-dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome •Pregnancy or lactation •If the patient has received any prior anti-cancer treatment, including radiotherapy, chemotherapy immunotherapy and/or immunomodulating agents, this must have been stopped at least 4 weeks before first study treatment administration. •Chemotherapy, glucocorticosteroides or other potentially immune-suppressive therapy that has been administered within 4 weeks prior to vaccination •No treatment with dacarbazin or temozolomide at any time prior to study entry •Any reason why, in the opinion of the investigator, the patient should not participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety and toxicity of vaccination with DCs transfected with h-TERT mRNA, survivin mRNA and autologous tumor cell mRNA, lymphodepletion treatment and T cell expansion and reinfusion in patients with metastatic malignant melanoma.;Secondary Objective: Evaluation of immunological responses, time to disease progression and survival time.;Primary end point(s): The primary end-point of this study is: Safety and toxicity of the vaccination with mRNA transfected DCs, the lymphodepletion treatment, and the T cell expansion and reinfusion in terms of occurrence of related adverse events, especially grade 3/4 adverse events assessed by reference to the NCI Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE). Biochemistry, hematology, vital signs and ECOG performance status will also be assessed. The secondary end-points of this study are: Evaluation of immunological responses in terms of SI = 2 or delta ? = 10.000 measured by the 3H-thymidine proliferation test before and after potential T cell expansion and reinfusion. Evaluation of clinical responses in terms of time to disease progression, also slow progressive disease, and survival time measured from the time of study-enrolment. | — |
Countries
Norway
Outcome results
None listed