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NCT00197860·Phase 1 / Phase 2·INTERVENTIONAL

Dendritic Cell Based Therapy of Renal Cell Carcinoma

Thymosin Alpha-1OtherCompleted

Status

Completed

Phase

Phase 1 / Phase 2

Enrollment

40

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

The purpose of this study is to show if vaccination with autologous dendritic cells pulsed with peptides or tumor lysate in combination with adjuvant cytokines can induce a measurable immune response in patients with metastatic renal cell carcinoma, and to evaluate the clinical effect (objective response rate) of the vaccination regime.

Full 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; 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 and Thymosin alpha 1 (Zadaxin®, SciClone) 1,6 mg s.c. twice a week are used for adjuvants. Scans and re-staging tests are performed at scheduled intervals throughout the study.

Interventions

Treatment arms and agents.

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 survivin and telomerase peptide-pulsed dendritic cells, and HLA-A2 negative patients are treated with allogeneic tumor lysate-pulsed dendritic cells i.d. 1,6 mg Thymosin alpha 1 (Zadaxin®, SciClone) is administered s.c. twice a week and from the 2nd vaccine, 2 MIU Interleukin-2 is administered s.c. on day 2-6.

Timeline

From registration to results.

  1. First posted

    Sep 20, 2005

  2. Study start

    Sep 2004

  3. Primary completion

    Dec 2009

  4. Study completion

    Oct 2010

  5. Results posted

    Not reported

  6. Registry updated

    Nov 23, 2011

Outcomes

What the study measures.

Primary outcomes

Primary aim of the study is to evaluate tolerability and safety of the treatment.

Time frame · weekly for the first four weeks, thereafter biweekly

Secondary outcomes

Secondary aims: evaluation of treatment induced immune response and clinical response.

Time frame · after 8 and 16 weeks of treatment

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Histologically proven progressive metastatic or locally advanced renal cell carcinoma * 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 4 times the upper limit of normal. * Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis.

Study locations

1 registered sites.

Denmark. Showing up to 24 locations stored in the fast local snapshot.

Department of Oncology, Copenhagen University Hospital, Herlev

Herlev, Denmark

Publications

Results and literature.

PMID 14985857 ↗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.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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