NCT01219348

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2010

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2010

Completed
22 days until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 18, 2015

Status Verified

August 1, 2015

Enrollment Period

2.2 years

First QC Date

May 10, 2010

Last Update Submit

August 17, 2015

Conditions

NSCLCLung Cancer

Keywords

IDO enzymeVaccination trialImmunotherapyNSCLC, stage III_IVIndeolamine 2,3 dioxygenase = IDO

Outcome Measures

Primary Outcomes (1)

  • evidence of toxicity

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

    12 months

Secondary Outcomes (1)

  • evaluation of immunological and clinical responses

    18 months

Study Arms (1)

Indeolamine 2,3 deoxygenase

EXPERIMENTAL

To inhibit immune suppression and tolerance, by blocking the IDO enzyme with vaccination against IDO.

Biological: IDO peptide vaccination

Interventions

IDO peptide vaccinationBIOLOGICAL

Vaccination every second week

Indeolamine 2,3 deoxygenase

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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
  • ASAT \< 100 U/L

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center for Cancer ImmuneTherapy

Herlev, Copenhagen, 2730, Denmark

Location

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

Copenhagen, Herlev, Copenhagen, 2730, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 24218513DERIVED

  • 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.

    PMID: 22388712DERIVED

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Trine Zeeberg Iversen, MD

    Center for Cancer Immune Therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof., MD, PhD

Study Record Dates

First Submitted

May 10, 2010

First Posted

October 13, 2010

Study Start

June 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 18, 2015

Record last verified: 2015-08

Locations

DK(2)