Back to resultsDendritic Cell Based Therapy of Malignant Melanoma
Primary Purpose
Advanced Melanoma
Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
tumor antigen loaded autologous dendritic cells
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Melanoma focused on measuring dendritic cell, cancer vaccine, cyclophosphamide, melanoma
Eligibility Criteria
Inclusion Criteria: Histologically proven progressive metastatic or locally advanced melanoma No standard treatment indicated Age: > 18 WHO-Performance Status 0-1 At least tone measurable tumor lesions according to the RECIST criteria. Life expectancy more than 3 months Acceptable CBC and blood chemistry results Written informed consent Exclusion Criteria: Patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin). Patients with metastatic disease in the central nervous system (CNS). Patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure. Patients with acute or chronic infection including HIV, hepatitis and tuberculosis. Patients who are pregnant. Patients who have received antineoplastic therapy including chemotherapy or immunotherapy less than 4 weeks before beginning the trial. Patients who receive corticosteroids or other immunosuppressive agents. Baseline serum LDH greater than 2.5 times the upper limit of normal. Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis.
Sites / Locations
- Department of Oncology, Copenhagen University Hospital, Herlev
Outcomes
Primary Outcome Measures
Primary aim of the study is to evaluate tolerability and safety of the treatment
Secondary Outcome Measures
Secondary aims: evaluation of treatment induced immune response and clinical response.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00197912
Brief Title
Dendritic Cell Based Therapy of Malignant Melanoma
Official Title
Vaccination With Autologous Dendritic Cells Pulsed With Tumor Antigens for Treatment of Patients With Malignant Melanoma. Phase I/II Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Herlev Hospital
4. Oversight
5. Study Description
Brief Summary
The aim of the study is to show if vaccination with autologous dendritic cells pulsed with peptides or tumor lysate in combination with adjuvant cytokines and Cyclophosphamide can induce a measurable immune response in patients with metastatic malignant melanoma, and to evaluate the clinical effect (objective response rate) of the vaccination regime.
Detailed Description
Eligible patients receive vaccination with tumor antigen pulsed autologous monocyte-derived mature dendritic cells with a fixed interval. The dendritic cells are generated from leukapheresis products and frozen after antigen loading.
HLA A2 positive patients are treated with PADRE and oncopeptide pulsed DC; p53, survivin and telomerase peptides. HLA A2 negative patients are treated with KLH and tumorlysate pulsed DC; autologous or allogeneic. Each patient is given 6 immunizations with at least 5x106 peptide/lysate pulsed autologous DC. Vaccination 1-4 is given weekly and 4-6 at 2-week intervals. Those patients who exhibit stable disease, partial response or complete response after 6 injections will be given 4 more vaccinations at 2-week interval. The vaccine is applied by intradermal injection near the inguinal region.
IL-2 2 MIU s.c. day 2-6, Cyclophosphamide (Sendoxan®, Baxter A/S) 50 mg twice a day bi-weekly and 200 mg Celecoxib (Celebra®, Pfizer) daily are used. Scans and re-staging tests are performed at scheduled intervals throughout the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Melanoma
Keywords
dendritic cell, cancer vaccine, cyclophosphamide, melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
tumor antigen loaded autologous dendritic cells
Other Intervention Name(s)
Dendritic cell vaccine, Cyclophosphamide, Sendoxan®, Baxter A/S, Celecoxib, Celebra®, Pfizer, Interleukin-2, Proleukin®, Chiron B.V.
Intervention Description
DC vaccination regime consists of primary 10 intradermal injections of 1-2 weeks interval (q1w x 4 → q2w x 6). HLA-A2 positive patients are treated with p53, survivin and telomerase peptide-pulsed dendritic cells, and HLA-A2 negative patients are treated with allogeneic tumor lysate pulsed dendritic cells. 50 mg cyclophosphamide (Sendoxan®, Baxter A/S) is administered p.o. twice a day bi-weekly and 200 mg celecoxib (Celebra®, Pfizer) is given p.o. every day. From the 2nd vaccine, 2 MIU Interleukin-2 is administered s.c. on day 2-6.
Primary Outcome Measure Information:
Title
Primary aim of the study is to evaluate tolerability and safety of the treatment
Time Frame
weekly the first four weeks thereafter biweekly
Secondary Outcome Measure Information:
Title
Secondary aims: evaluation of treatment induced immune response and clinical response.
Time Frame
after 8 and 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically proven progressive metastatic or locally advanced melanoma
No standard treatment indicated
Age: > 18
WHO-Performance Status 0-1
At least tone measurable tumor lesions according to the RECIST criteria.
Life expectancy more than 3 months
Acceptable CBC and blood chemistry results
Written informed consent
Exclusion Criteria:
Patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin).
Patients with metastatic disease in the central nervous system (CNS).
Patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure.
Patients with acute or chronic infection including HIV, hepatitis and tuberculosis.
Patients who are pregnant.
Patients who have received antineoplastic therapy including chemotherapy or immunotherapy less than 4 weeks before beginning the trial.
Patients who receive corticosteroids or other immunosuppressive agents.
Baseline serum LDH greater than 2.5 times the upper limit of normal.
Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inge Marie Svane, MD, PHD
Organizational Affiliation
Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2760 Herlev, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oncology, Copenhagen University Hospital, Herlev
City
Herlev
ZIP/Postal Code
2970
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
14985857
Citation
Svane IM, Pedersen AE, Johnsen HE, Nielsen D, Kamby C, Gaarsdal E, Nikolajsen K, Buus S, Claesson MH. Vaccination with p53-peptide-pulsed dendritic cells, of patients with advanced breast cancer: report from a phase I study. Cancer Immunol Immunother. 2004 Jul;53(7):633-41. doi: 10.1007/s00262-003-0493-5. Epub 2004 Feb 25.
Results Reference
background
PubMed Identifier
22426890
Citation
Ellebaek E, Engell-Noerregaard L, Iversen TZ, Froesig TM, Munir S, Hadrup SR, Andersen MH, Svane IM. Metastatic melanoma patients treated with dendritic cell vaccination, Interleukin-2 and metronomic cyclophosphamide: results from a phase II trial. Cancer Immunol Immunother. 2012 Oct;61(10):1791-804. doi: 10.1007/s00262-012-1242-4. Epub 2012 Mar 20.
Results Reference
derived
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Dendritic Cell Based Therapy of Malignant Melanoma
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