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

Primary Purpose

NSCLC, Lung Cancer

Status

Completed

Phase

Phase 1

Locations

Denmark

Study Type

Interventional

Intervention

IDO peptide vaccination

About this trial

This is an interventional treatment trial for NSCLC focused on measuring IDO enzyme, Vaccination trial, Immunotherapy, NSCLC, stage III_IV, Indeolamine 2,3 dioxygenase = IDO

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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
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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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Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Indeolamine 2,3 deoxygenase

Arm Description

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

Outcomes

Primary Outcome Measures

evidence of toxicity

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

immunological assays will be used to identify immunological responses. CT scans will be used for evaluation of clinical responses.

Full Information

NCT ID

NCT01219348

First Posted

May 10, 2010

Last Updated

August 17, 2015

Sponsor

Inge Marie Svane

1. Study Identification

Unique Protocol Identification Number

NCT01219348

Brief Title

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

Acronym

IDOvaccine

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.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Inge Marie Svane

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

NSCLC, Lung Cancer

Keywords

IDO enzyme, Vaccination trial, Immunotherapy, NSCLC, stage III_IV, Indeolamine 2,3 dioxygenase = IDO

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Indeolamine 2,3 deoxygenase

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

IDO peptide vaccination

Intervention Description

Vaccination every second week

Primary Outcome Measure Information:

Title

evidence of toxicity

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

evaluation of immunological and clinical responses

Description

immunological assays will be used to identify immunological responses. CT scans will be used for evaluation of clinical responses.

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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 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 - Exclusion Criteria: 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 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. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Trine Zeeberg Iversen, MD

Organizational Affiliation

Center for Cancer Immune Therapy

Official's Role

Principal Investigator

Facility Information:

Facility Name

Center for Cancer ImmuneTherapy

City

Herlev

State/Province

Copenhagen

ZIP/Postal Code

2730

Country

Denmark

Facility Name

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

City

Copenhagen

State/Province

Herlev, Copenhagen

ZIP/Postal Code

2730

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

24218513

Citation

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.

Results Reference

derived

PubMed Identifier

22388712

Citation

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.

Results Reference

derived

Learn more about this trial

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

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