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Phase I/II Trial of Vaccine Therapy With mRNA- Transfected Dendritic Cells in Patients With Advanced Malignant Melanoma

Phase 1/Phase 2
18 Years
Not Enrolling
Malignant Melanoma

Thank you

Trial Information

Phase I/II Trial of Vaccine Therapy With mRNA- Transfected Dendritic Cells in Patients With Advanced Malignant Melanoma

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
┬Ámol/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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determination of safety and toxicity of vaccination with patients` tumour mRNA transfected DCs

Outcome Description:

Biochemistry and hematology results, vital signs and ECOG performance status are measured at those timepoints.

Outcome Time Frame:

Patients are coming every week during 6 weeks.

Safety Issue:


Principal Investigator

Steinar Aamdal, M.D PhD Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oslo University Hospital - Norwegian Radium Hospital


Norway: Norwegian Medicines Agency

Study ID:

DC malignant melanoma



Start Date:

March 2002

Completion Date:

August 2004

Related Keywords:

  • Malignant Melanoma
  • Melanoma