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
1 other identifier
interventional
31
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2002
Longer than P75 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 17, 2011
CompletedFirst Posted
Study publicly available on registry
January 19, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedAugust 15, 2016
August 1, 2016
3.9 years
January 17, 2011
August 12, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Determination of safety and toxicity of vaccination with patients' tumour mRNA transfected DCs
Biochemistry and hematology results, vital signs and ECOG performance status are measured at those timepoints.
Patients are coming every week during 6 weeks.
Secondary Outcomes (2)
Determine immunological response to the vaccine (induction of specific T-cell response)
6 weeks and 3 months after study start
Assessment of tumour response.
3 months after study start
Study Arms (2)
Dendritic Cells (DC) malignant melanoma
EXPERIMENTAL22 patients were included in this arm.
DC vaccine plus IL-2
EXPERIMENTALTo 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.
Interventions
The patients were assigned to intradermal or intranodal DC vaccination
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Kyte JA, Mu L, Aamdal S, Kvalheim G, Dueland S, Hauser M, Gullestad HP, Ryder T, Lislerud K, Hammerstad H, Gaudernack G. Phase I/II trial of melanoma therapy with dendritic cells transfected with autologous tumor-mRNA. Cancer Gene Ther. 2006 Oct;13(10):905-18. doi: 10.1038/sj.cgt.7700961. Epub 2006 May 5.
PMID: 16710345RESULTKyte JA, Kvalheim G, Lislerud K, thor Straten P, Dueland S, Aamdal S, Gaudernack G. T cell responses in melanoma patients after vaccination with tumor-mRNA transfected dendritic cells. Cancer Immunol Immunother. 2007 May;56(5):659-75. doi: 10.1007/s00262-006-0222-y. Epub 2006 Sep 1.
PMID: 16947019RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steinar Aamdal, M.D PhD Prof
Oslo University Hospital - Norwegian Radium Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
January 17, 2011
First Posted
January 19, 2011
Study Start
March 1, 2002
Primary Completion
February 1, 2006
Study Completion
December 1, 2015
Last Updated
August 15, 2016
Record last verified: 2016-08