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Dendritic Cell Based Therapy of Malignant Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00197912
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : April 26, 2010
Sponsor:
Information provided by:
Herlev Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Melanoma Biological: tumor antigen loaded autologous dendritic cells Phase 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vaccination With Autologous Dendritic Cells Pulsed With Tumor Antigens for Treatment of Patients With Malignant Melanoma. Phase I/II Study
Study Start Date : September 2004
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma Vaccines

Arms and Interventions
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Intervention Details:
  • Biological: tumor antigen loaded autologous dendritic cells
    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.
    Other Names:
    • Dendritic cell vaccine
    • Cyclophosphamide, Sendoxan®, Baxter A/S
    • Celecoxib, Celebra®, Pfizer
    • Interleukin-2, Proleukin®, Chiron B.V.

Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Secondary aims: evaluation of treatment induced immune response and clinical response. [ Time Frame: after 8 and 16 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00197912


Locations
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Denmark
Department of Oncology, Copenhagen University Hospital, Herlev
Herlev, Denmark, 2970
Sponsors and Collaborators
Herlev Hospital
Investigators
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Principal Investigator: Inge Marie Svane, MD, PHD Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2760 Herlev, Denmark
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Inge Marie Svane, MD, PhD, Department of Oncology, Herlev Hospital
ClinicalTrials.gov Identifier: NCT00197912    
Other Study ID Numbers: MM0413
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 26, 2010
Last Verified: July 2009
Keywords provided by Herlev Hospital:
dendritic cell
cancer vaccine
cyclophosphamide
melanoma
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Celecoxib
Cyclophosphamide
Interleukin-2
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents
 Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors