Malignant Melanoma
Conditions
Brief summary
PRIMARY OBJECTIVES: Determination of safety and toxicity of vaccination with patients' tumour mRNA transfected DCs . SECONDARY OBJECTIVES:Determine immunological response to the vaccine (induction of specific T-cell response) and assessment of tumour response
Interventions
BIOLOGICALDendritic Cells (DC) malignant melanoma
The patients were assigned to intradermal or intranodal DC vaccination
PROCEDUREIL-2
IL-2 were administrated by intranodal injection
Sponsors
Oslo University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Accessible tumour tissue for vaccine production (extraction of tumour mRNA) i.e.subcutaneous or lymph node metastases. * Must be at least 18 years of age. * Must have histologically confirmed advanced, metastatic cutaneous melanoma no longer amenable for surgery. * Must have evidence of disease progression and measurable or evaluable metastases * Must be ambulatory with a ECOG performance score of \<2 * Must have lab.values as following : ANC \> 1.5 x 109/L; platelets \> 100 x 109/L, Hb \> 9g/dL (\> 5.6 mmol/L). Creatinine \< 140 µmol/L (1.6 mg/dL); if borderline, the creatinine clearance \> 40 mL/min, Bilirubin \< 20% above the upper limit of normal, ASAT and ALAT \< 2.5 the upper limit of normal. Albumin \> 2.5 g/L. * Prior radiotherapy: A minimum of 4 weeks (8 weeks in case of extensive radiotherapy) must have elapsed between the end of the prior radiotherapy and entry into the protocol. * Prior chemotherapy: A minimum 4 weeks must have elapsed between the end of the prior chemotherapy and entry into the protocol. * Signed informed consent of the patients for the treatment and follow up must be obtained and documented according to the ICH-GCP Guidelines.
Exclusion criteria
* History of prior malignancy other than melanoma, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin and ca. cervix stage 1B. * Active infection requiring antibiotic therapy. * Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia. * Autoimmune disease currently treated with 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. * Chemotherapy or other potentially immune-suppressive therapy that has been administered within 4 weeks prior to vaccination. * Pregnancy or lactation. * Any reason why, in the opinion of the investigator, the patient should not participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of safety and toxicity of vaccination with patients' tumour mRNA transfected DCs | Patients are coming every week during 6 weeks. | Biochemistry and hematology results, vital signs and ECOG performance status are measured at those timepoints. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine immunological response to the vaccine (induction of specific T-cell response) | 6 weeks and 3 months after study start | — |
| Assessment of tumour response. | 3 months after study start | CT-scan |
Outcome results
None listed