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Trial record 1 of 1 for:    NCT01219348
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IDO Peptid Vaccination for Stage III-IV Non Small-cell Lung Cancer Patients. (IDOvaccine)

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

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.

Condition or disease Intervention/treatment Phase
NSCLC Lung Cancer Biological: IDO peptide vaccination Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Study Start Date : June 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Indeolamine 2,3 deoxygenase
To inhibit immune suppression and tolerance, by blocking the IDO enzyme with vaccination against IDO.
Biological: IDO peptide vaccination
Vaccination every second week

Primary Outcome Measures :
  1. evidence of toxicity [ Time Frame: 12 months ]
    CTCAE = Common Terminology Criteria for Adverse Events v. 3.0 will be used for registration of toxicity

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.


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 identifier (NCT number): NCT01219348

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Center for Cancer ImmuneTherapy
Herlev, Copenhagen, Denmark, 2730
Center for Cancer Immune Therapy, Dept. og Haematology/Oncology
Copenhagen, Herlev, Copenhagen, Denmark, 2730
Sponsors and Collaborators
Inge Marie Svane
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Principal Investigator: Trine Zeeberg Iversen, MD Center for Cancer Immune Therapy
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Inge Marie Svane, Prof., MD, PhD, Herlev Hospital Identifier: NCT01219348    
Other Study ID Numbers: LU 1006 - IDO
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: August 18, 2015
Last Verified: August 2015
Keywords provided by Inge Marie Svane, Herlev Hospital:
IDO enzyme
Vaccination trial
Indeolamine 2,3 dioxygenase = IDO
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases