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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.

Phase 1
18 Years
Not Enrolling
NSCLC, Lung Cancer

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Trial Information

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.

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

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.

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.


Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

evidence of toxicity

Outcome Description:

CTCAE = Common Terminology Criteria for Adverse Events v. 3.0 will be used for registration of toxicity

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Trine Zeeberg Iversen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Center for Cancer Immune Therapy


Denmark: Danish Dataprotection Agency

Study ID:

LU 1006 - IDO



Start Date:

June 2010

Completion Date:

August 2012

Related Keywords:

  • Lung Cancer
  • IDO enzyme
  • Vaccination trial
  • Immunotherapy
  • NSCLC, stage III_IV
  • Indeolamine 2,3 dioxygenase = IDO
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms