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.
18 Years
N/A
Both
NSCLC, Lung Cancer
Trial Information
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.
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.
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.
-
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
evidence of toxicity
Outcome Description:
CTCAE = Common Terminology Criteria for Adverse Events v. 3.0 will be used for registration of toxicity
Outcome Time Frame:
12 months
Safety Issue:
Yes
Principal Investigator
Trine Zeeberg Iversen, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Center for Cancer Immune Therapy
Authority:
Denmark: Danish Dataprotection Agency
Study ID:
LU 1006 - IDO
NCT ID:
NCT01219348
Start Date:
June 2010
Completion Date:
August 2012
Related Keywords:
- NSCLC
- Lung Cancer
- IDO enzyme
- Vaccination trial
- Immunotherapy
- NSCLC, stage III_IV
- Indeolamine 2,3 dioxygenase = IDO
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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