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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Inge Marie Svane, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01219348
First received: May 10, 2010
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
NSCLC
Lung Cancer
Biological: IDO peptide vaccination
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

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


Secondary Outcome Measures:
  • evaluation of immunological and clinical responses [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    immunological assays will be used to identify immunological responses. CT scans will be used for evaluation of clinical responses.


Enrollment: 14
Study Start Date: June 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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    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.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01219348

Locations
Denmark
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
Investigators
Principal Investigator: Trine Zeeberg Iversen, MD Center for Cancer Immune Therapy
  More Information

No publications provided by Herlev Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Inge Marie Svane, Prof., MD, PhD, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01219348     History of Changes
Other Study ID Numbers: LU 1006 - IDO
Study First Received: May 10, 2010
Last Updated: March 19, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Herlev Hospital:
IDO enzyme
Vaccination trial
Immunotherapy
NSCLC, stage III_IV
Indeolamine 2,3 dioxygenase = IDO

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 16, 2014