Status:
COMPLETED
IDO Peptid Vaccination for Stage III-IV Non Small-cell Lung Cancer Patients.
Lead Sponsor:
Inge Marie Svane
Conditions:
NSCLC
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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. ...
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 tria...
Eligibility Criteria
Inclusion
- 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
- 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.
- \-
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01219348
Start Date
June 1 2010
End Date
August 1 2012
Last Update
August 18 2015
Active Locations (2)
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1
Center for Cancer ImmuneTherapy
Herlev, Copenhagen, Denmark, 2730
2
Center for Cancer Immune Therapy, Dept. og Haematology/Oncology
Copenhagen, Herlev, Copenhagen, Denmark, 2730