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

Primary Purpose

Malignant Melanoma

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Dendritic Cells (DC) malignant melanoma

IL-2

About this trial

This is an interventional treatment trial for Malignant Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Dendritic Cells (DC) malignant melanoma

DC vaccine plus IL-2

Arm Description

22 patients were included in this arm.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Determine immunological response to the vaccine (induction of specific T-cell response)

Assessment of tumour response.

CT-scan

Full Information

NCT ID

NCT01278940

First Posted

January 17, 2011

Last Updated

August 12, 2016

Sponsor

Oslo University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01278940

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

March 2002 (undefined)

Primary Completion Date

February 2006 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oslo University Hospital

4. Oversight

Data Monitoring Committee

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dendritic Cells (DC) malignant melanoma

Arm Type

Experimental

Arm Description

22 patients were included in this arm.

Arm Title

DC vaccine plus IL-2

Arm Type

Experimental

Arm Description

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.

Intervention Type

Biological

Intervention Name(s)

Dendritic Cells (DC) malignant melanoma

Intervention Description

The patients were assigned to intradermal or intranodal DC vaccination

Intervention Type

Procedure

Intervention Name(s)

IL-2

Intervention Description

IL-2 were administrated by intranodal injection

Primary Outcome Measure Information:

Title

Determination of safety and toxicity of vaccination with patients' tumour mRNA transfected DCs

Description

Biochemistry and hematology results, vital signs and ECOG performance status are measured at those timepoints.

Time Frame

Patients are coming every week during 6 weeks.

Secondary Outcome Measure Information:

Title

Determine immunological response to the vaccine (induction of specific T-cell response)

Time Frame

6 weeks and 3 months after study start

Title

Assessment of tumour response.

Description

CT-scan

Time Frame

3 months after study start

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steinar Aamdal, M.D PhD Prof

Organizational Affiliation

Oslo University Hospital - Norwegian Radium Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

16710345

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):905-18. doi: 10.1038/sj.cgt.7700961. Epub 2006 May 5.

Results Reference

result

PubMed Identifier

16947019

Citation

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.

Results Reference

result

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

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