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Trial #NCT01219348
NSCLC Clinical Trials

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


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 ID: LU 1006 - IDO; Source: Herlev Hospital
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Definitions
Interventional trials
Determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
Observational trials
Address health issues in large groups of people or populations in natural settings.
Recruiting
Participants are currently being recruited and enrolled.
Active, not recruiting
Study is ongoing (i.e., patients are being treated or examined), but enrollment has completed.
Not yet recruiting
Participants are not yet being recruited or enrolled.
Enrolling by invitation
Participants are being (or will be) selected from a predetermined population.
Completed
The study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred).
Withdrawn
Study halted prematurely, prior to enrollment of first participant.
Suspended
Recruiting or enrolling participants has halted prematurely but potentially will resume.
Terminated
Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.
Status Completed
Country Denmark
Study type Interventional
Enrollment 14
Start date June 2010
Completion date August 2012
Phase Phase 1
Sponsor Herlev Hospital
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.
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.
Eligibility:
Gender: Both
Age: 18 Years - N/A
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.
-
Outcome:
Primary outcome
  • evidence of toxicity
    CTCAE = Common Terminology Criteria for Adverse Events v. 3.0 will be used for registration of toxicity
    Time frame: 12 months
Secondary outcome
  • evaluation of immunological and clinical responses
    immunological assays will be used to identify immunological responses. CT scans will be used for evaluation of clinical responses.
    Time frame: 18 months
Contacts:
  • Trine Zeeberg Iversen, MD; Center for Cancer Immune Therapy (Principal Investigator)
Location Country Status
Center for Cancer ImmuneTherapy Herlev, Copenhagen Denmark
Center for Cancer Immune Therapy, Dept. og Haematology/Oncology Copenhagen, Herlev, Copenhagen Denmark
Sponsors:
  • Inge Marie Svane - (Lead Sponsor)

Related trials: Terms
  • IDO enzyme
  • Indeolamine 2,3 dioxygenase = IDO
  • NSCLC, stage III_IV
  • Immunotherapy
  • Vaccination trial
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