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IDO Peptid Vaccination for Stage III-IV Non Small-cell Lung Cancer Patients. (IDOvaccine)

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ClinicalTrials.gov Identifier: NCT01219348
Recruitment Status : Completed
First Posted : October 13, 2010
Last Update Posted : August 18, 2015
Sponsor:
Information provided by (Responsible Party):
Inge Marie Svane, Herlev Hospital

Tracking Information
First Submitted Date  ICMJE May 10, 2010
First Posted Date  ICMJE October 13, 2010
Last Update Posted Date August 18, 2015
Study Start Date  ICMJE June 2010
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2010)
evidence of toxicity [ Time Frame: 12 months ]
CTCAE = Common Terminology Criteria for Adverse Events v. 3.0 will be used for registration of toxicity
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01219348 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2010)
evaluation of immunological and clinical responses [ Time Frame: 18 months ]
immunological assays will be used to identify immunological responses. CT scans will be used for evaluation of clinical responses.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IDO Peptid Vaccination for Stage III-IV Non Small-cell Lung Cancer Patients.
Official Title  ICMJE IDO Peptid Vaccination in Combination With Immune Stimulating Agent Aldara and the Adjuvant Montanide, for Treatment of Patients With Locally Advanced or Metastatic Non Small-cell Lung Cancer. A First-in-man Phase I Trial.
Brief Summary

Title: IDO peptid vaccination in combination with immune stimulating agent Aldara and the adjuvant Montanide, for treatment of patients with locally advanced or metastatic non small-cell lung cancer. A first-in-man phase I trial.

Hypothesis: In this trial the investigators assess a new immunotherapeutic strategy targeting the immune inhibiting enzyme, IDO to investigate the potential of vaccination against IDO as a possible anticancer target.

Detailed Description

Background: Non small-cell lung cancer (NSCLC) is a common disease with a poor prognosis when locally advanced or metastasized, despite advances in surgery, chemo- and radiation therapy.

In this trial the investigators assess a new immunotherapeutic strategy targeting the immune inhibiting enzyme, IDO to investigate the potential of vaccination against IDO as a possible anticancer target.

IDO has recently been recognized as an important factor in immune regulation and development of immune tolerance in the microenvironment of cancer cells. Cells that represent IDO at their surface are known to inhibit the immune system. IDO expression is seen both in cancer cells and antigen presenting cells. The vaccination against IDO expressing cells is therefore two-sided. The vaccination therapy is thought to block the development of immune tolerance induced by IDO expressing cells. At the same time the investigators aim to stimulate the production of IDO specific T-cells, hence facilitating the elimination of IDO positive tumour cells. The primary end points are safety and toxicity evaluation. Secondary end points are immunological and clinical response.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • NSCLC
  • Lung Cancer
Intervention  ICMJE Biological: IDO peptide vaccination
Vaccination every second week
Study Arms  ICMJE Experimental: Indeolamine 2,3 deoxygenase
To inhibit immune suppression and tolerance, by blocking the IDO enzyme with vaccination against IDO.
Intervention: Biological: IDO peptide vaccination
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 12, 2010)
14
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

1. Histological or cytological verified non small cell lung cancer 2. Metastatic or locally advanced incurable stage III-IV NSCLC 3. Patients need to be off chemotherapy treatment 4. Evaluable disease according to RECIST V. 1,1 criteria 5. Patients must be HLA-A2 positive 6. Patients > 18 years old 7. Performance status 0-1 8. Life expectancy of > 3 months 9. Acceptable bone marrow function, defined as

a. White blood cell count > 2,5 * 109 /l b. Neutrophil count> 1,5 * 109 /l c. Platelet count > 75 * 109/l 10. Creatinin measured < 2,5 * upper limit value 11. Acceptable liver function, defined as

  1. ASAT < 100 U/L
  2. Bilirubin < 30 U/L 12. Women with child-bearing potential must have controlled s-hcg before inclusion 13. Patients must provide written informed concent before inclusion 13. Termination of chemotherapy treatment > 28 days before inclusion

    14. Termination of radiotherapy treatment > 28 days before inclusion

    15. Inclusion at least > 4 weeks after complicated gastric surgery

    -

    Exclusion Criteria:

    1. Other malignancies except from non-melanoma skin cancer in the previous 5 years until study inclusion
    2. Brain metastasis are allowed after radical excision, and if the patient at least 1 month afterwards is not in clinical or radiographic progression
    3. Patients with active gastric ulcer disease; patients taking antacid treatment can be included.
    4. Severe medical condition, severe asthma, severe COLD, severe arteriosclerosis or diabetic disease
    5. Acute or chronic infection (ie. HIV, hepatitis, tuberculosis)
    6. Severe allergic reaction or previous anaphylactic shock
    7. Autoimmune diseases (ie. autoimmune neutropenia/thrombopenia, hæmolytic anaemia, systemic lupus erythematosis, Sjøgrens disease, sclerodermia, Goodpastures syndrome, Addisons disease, active Graves disease)
    8. Pregnant or lactating women
    9. Psychiatric disease, which can influence compliance
    10. Known hypersensitivity towards the adjuvance Montanide, the Aldara creme, or adhesive tape.
    11. Treatment with immunosuppressive therapy (ie. dexamethasone, methotrexate)
    12. Treatment with other experimental therapy
    13. Treatment with other anti-cancer therapy, except from treatment of osteoporosis
    14. No systemic chemotherapy, immunotherapy or radiation therapy (except locally) are allowed until 28 days before inclusion.

      -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01219348
Other Study ID Numbers  ICMJE LU 1006 - IDO
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Inge Marie Svane, Herlev Hospital
Study Sponsor  ICMJE Inge Marie Svane
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Trine Zeeberg Iversen, MD Center for Cancer Immune Therapy
PRS Account Herlev Hospital
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP