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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:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01278940
First received: January 17, 2011
Last updated: July 21, 2011
Last verified: July 2011
History of Changes
  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
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group 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:

MedlinePlus related topics: Cancer Melanoma
U.S. FDA Resources

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: 22
Arms Assigned Interventions
Experimental: DC malignant melanoma Biological: Dendritic Cells (DC) malignant melanoma

  Eligibility

Ages Eligible for Study:   18 Years and older
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
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: Prof. Steinar Aamdal/Head of Section for Clinical Cancer Research, 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: July 21, 2011
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

ClinicalTrials.gov processed this record on May 19, 2013