Trial of Vaccine Therapy With mRNA- Transfected Dendritic Cells in Patients With Advanced Malignant Melanoma

This study has been completed.
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01278940
First received: January 17, 2011
Last updated: June 26, 2013
Last verified: June 2013

January 17, 2011
June 26, 2013
March 2002
August 2004   (final data collection date for primary outcome measure)
Determination of safety and toxicity of vaccination with patients` tumour mRNA transfected DCs [ Time Frame: Patients are coming every week during 6 weeks. ] [ Designated as safety issue: Yes ]
Biochemistry and hematology results, vital signs and ECOG performance status are measured at those timepoints.
Not Provided
Complete list of historical versions of study NCT01278940 on ClinicalTrials.gov Archive Site
  • Determine immunological response to the vaccine (induction of specific T-cell response) [ Time Frame: 6 weeks and 3 months after study start ] [ Designated as safety issue: No ]
  • Assessment of tumour response. [ Time Frame: 3 months after study start ] [ Designated as safety issue: No ]
    CT-scan
Not Provided
Not Provided
Not Provided
 
Trial of Vaccine Therapy With mRNA- Transfected Dendritic Cells in Patients With Advanced Malignant Melanoma
Phase I/II Trial of Vaccine Therapy With mRNA- Transfected Dendritic Cells in Patients With Advanced Malignant Melanoma

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

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Melanoma
Biological: Dendritic Cells (DC) malignant melanoma
Experimental: DC malignant melanoma
Intervention: Biological: Dendritic Cells (DC) malignant melanoma

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
August 2004
August 2004   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01278940
DC malignant melanoma
No
Prof. Steinar Aamdal/Head of Section for Clinical Cancer Research, Oslo University Hospital
Oslo University Hospital
Not Provided
Principal Investigator: Steinar Aamdal, M.D PhD Prof Oslo University Hospital - Norwegian Radium Hospital
Oslo University Hospital
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP