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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Svein Dueland, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01278940
First received: January 17, 2011
Last updated: August 12, 2016
Last verified: August 2016
  Purpose

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


Condition Intervention Phase
Malignant Melanoma
Biological: Dendritic Cells (DC) malignant melanoma
Procedure: IL-2
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Trial of Vaccine Therapy With mRNA- Transfected Dendritic Cells in Patients With Advanced Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 31
Study Start Date: March 2002
Study Completion Date: December 2015
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dendritic Cells (DC) malignant melanoma
22 patients were included in this arm.
Biological: Dendritic Cells (DC) malignant melanoma
The patients were assigned to intradermal or intranodal DC vaccination
Experimental: DC vaccine plus IL-2
To improve the efficacy of the DC vaccine, IL-2 was administrated at the vaccination site through direct lymph node injection. 9 patients were included in this arm.
Biological: Dendritic Cells (DC) malignant melanoma
The patients were assigned to intradermal or intranodal DC vaccination
Procedure: IL-2
IL-2 were administrated by intranodal injection

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01278940

Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Steinar Aamdal, M.D PhD Prof Oslo University Hospital - Norwegian Radium Hospital
  More Information

Publications:
Responsible Party: Svein Dueland, MD, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01278940     History of Changes
Other Study ID Numbers: DC malignant melanoma 
Study First Received: January 17, 2011
Last Updated: August 12, 2016
Health Authority: Norway: Norwegian Medicines Agency
Norway: Intititional Review Board

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016