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

NCT ID: NCT01278940

Last Updated: 2016-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31
• Study Completion Date: 2015-12-31

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

Conditions

Malignant Melanoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dendritic Cells (DC) malignant melanoma

22 patients were included in this arm.

Group Type: EXPERIMENTAL

Dendritic Cells (DC) malignant melanoma

Intervention Type: BIOLOGICAL

The patients were assigned to intradermal or intranodal DC vaccination

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.

Group Type: EXPERIMENTAL

Dendritic Cells (DC) malignant melanoma

Intervention Type: BIOLOGICAL

The patients were assigned to intradermal or intranodal DC vaccination

IL-2

Intervention Type: PROCEDURE

IL-2 were administrated by intranodal injection

Interventions

Dendritic Cells (DC) malignant melanoma

The patients were assigned to intradermal or intranodal DC vaccination

Intervention Type: BIOLOGICAL

IL-2

IL-2 were administrated by intranodal injection

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Svein Dueland

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steinar Aamdal, M.D PhD Prof

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital - Norwegian Radium Hospital

References

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.

Reference Type: RESULT

PMID: 16710345 (View on PubMed)

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. doi: 10.1007/s00262-006-0222-y. Epub 2006 Sep 1.

Reference Type: RESULT

PMID: 16947019 (View on PubMed)

Other Identifiers

DC malignant melanoma

Identifier Type: -

Identifier Source: org_study_id