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

Malignant Melanoma Clinical Trial

Official title:

Phase I/II Trial of Vaccine Therapy With mRNA- Transfected Dendritic Cells in Patients With Advanced Malignant Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01278940
• Other study ID #: DC malignant melanoma
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 17, 2011
• Last updated: August 12, 2016
• Start date: March 2002
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencyNorway: Intititional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2015
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

References & Publications (2)

Kyte 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. Epub 2006 Sep 1. — View Citation

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):90 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	Determine immunological response to the vaccine (induction of specific T-cell response)		6 weeks and 3 months after study start	No
Secondary	Assessment of tumour response.	CT-scan	3 months after study start	No