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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01278940
Recruitment Status : Completed
First Posted : January 19, 2011
Last Update Posted : August 15, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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


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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2002
Primary Completion Date : February 2006
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Determination of safety and toxicity of vaccination with patients` tumour mRNA transfected DCs [ Time Frame: Patients are coming every week during 6 weeks. ]
    Biochemistry and hematology results, vital signs and ECOG performance status are measured at those timepoints.


Secondary Outcome Measures :
  1. Determine immunological response to the vaccine (induction of specific T-cell response) [ Time Frame: 6 weeks and 3 months after study start ]
  2. Assessment of tumour response. [ Time Frame: 3 months after study start ]
    CT-scan


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: January 19, 2011    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016

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