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

Lung Cancer Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01219348
• Other study ID #: LU 1006 - IDO
• Status: Completed
• Phase: Phase 1
• First received: May 10, 2010
• Last updated: August 17, 2015
• Start date: June 2010
• Est. completion date: August 2012

Study information

• Verified date: August 2015
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• NSCLC

Intervention

Biological:
• IDO peptide vaccination
Vaccination every second week

Locations

Country	Name	City	State
Denmark	Center for Cancer Immune Therapy, Dept. og Haematology/Oncology	Copenhagen	Herlev, Copenhagen
Denmark	Center for Cancer ImmuneTherapy	Herlev	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Inge Marie Svane

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evidence of toxicity	CTCAE = Common Terminology Criteria for Adverse Events v. 3.0 will be used for registration of toxicity	12 months	Yes
Secondary	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.	18 months	No