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NSCLCPhase 1IDOvaccineNCT01219348

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

A Phase 1 study testing IDO peptide vaccination in people with NSCLC and Lung Cancer, run by Inge Marie Svane at 2 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC, Lung Cancer
What is being tested?
IDO peptide vaccination
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
2 sitesDenmark
Study dates
Jun 2010to Aug 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 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
  • ASAT < 100 U/L
  • 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
  • -

Who cannot join

  • Other malignancies except from non-melanoma skin cancer in the previous 5 years until study inclusion
  • Brain metastasis are allowed after radical excision, and if the patient at least 1 month afterwards is not in clinical or radiographic progression
  • Patients with active gastric ulcer disease; patients taking antacid treatment can be included.
  • Severe medical condition, severe asthma, severe COLD, severe arteriosclerosis or diabetic disease
  • Acute or chronic infection (ie. HIV, hepatitis, tuberculosis)
  • Severe allergic reaction or previous anaphylactic shock
Show all 15Show fewer
  • Autoimmune diseases (ie. autoimmune neutropenia/thrombopenia, hæmolytic anaemia, systemic lupus erythematosis, Sjøgrens disease, sclerodermia, Goodpastures syndrome, Addisons disease, active Graves disease)
  • Pregnant or lactating women
  • Psychiatric disease, which can influence compliance
  • Known hypersensitivity towards the adjuvance Montanide, the Aldara creme, or adhesive tape.
  • Treatment with immunosuppressive therapy (ie. dexamethasone, methotrexate)
  • Treatment with other experimental therapy
  • Treatment with other anti-cancer therapy, except from treatment of osteoporosis
  • No systemic chemotherapy, immunotherapy or radiation therapy (except locally) are allowed until 28 days before inclusion.
  • -

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Center for Cancer Immune Therapy, Dept. og Haematology/Oncology

    Copenhagen, Herlev, Copenhagen, 2730

  • Center for Cancer ImmuneTherapy

    Herlev, Copenhagen, 2730

Other trials in Denmark

About this study

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.

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.

Read the 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.

Conditions
NSCLC, Lung Cancer
Being tested
IDO peptide vaccination
Keywords
IDO enzyme, Vaccination trial, Immunotherapy, NSCLC, stage III_IV, Indeolamine 2,3 dioxygenase = IDO
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IDO peptide vaccinationBiological

    Vaccination every second week

Study groups in NCT01219348
Study groupRoleWhat they receive
Indeolamine 2,3 deoxygenaseExperimentalTo inhibit immune suppression and tolerance, by blocking the IDO enzyme with vaccination against IDO.
Receives: Biological: IDO peptide vaccination

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. evidence of toxicity

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

    Measured: 12 months

Secondary outcomes (1)

  1. 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.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionAug 2012
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01219348
Sponsor's protocol ID
LU 1006 - IDO
Acronym
IDOvaccine
Status last verified
Aug 2015
First submitted
10 May 2010
Last updated
18 Aug 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Iversen TZ, Engell-Noerregaard L, Ellebaek E, Andersen R, Larsen SK, Bjoern J, Zeyher C, Gouttefangeas C, Thomsen BM, Holm B, Thor Straten P, Mellemgaard A, Andersen MH, Svane IM. Long-lasting disease stabilization in the absence of toxicity in metastatic lung cancer patients vaccinated with an epitope derived from indoleamine 2,3 dioxygenase. Clin Cancer Res. 2014 Jan 1;20(1):221-32. doi: 10.1158/1078-0432.CCR-13-1560. Epub 2013 Nov 11.

    PubMed 24218513

  • Andersen MH. The specific targeting of immune regulation: T-cell responses against Indoleamine 2,3-dioxygenase. Cancer Immunol Immunother. 2012 Aug;61(8):1289-97. doi: 10.1007/s00262-012-1234-4. Epub 2012 Mar 3.

    PubMed 22388712

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IDO peptide vaccination in people with NSCLC and Lung Cancer, run by Inge Marie Svane at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

evidence of toxicity (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01219348, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2015.

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