Overview

Peptide Vaccine and Temozolomide for Metastatic Melanoma Patients

Status:
Terminated
Trial end date:
2016-09-01
Target enrollment:
0
Participant gender:
All
Summary
The aim of the study is to assess if treatment with IDO/Survivin peptide vaccine can enhance the efficacy of temozolomide chemotherapy in patients with metastatic malignant melanoma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Inge Marie Svane
Collaborator:
Copenhagen University Hospital at Herlev
Treatments:
Dacarbazine
Imiquimod
Temozolomide
Vaccines
Criteria
Inclusion Criteria:

1. Histological verified malignant melanoma

2. Metastatic disease (brain metastasis allowed if asymptomatic)

3. Evaluable disease recording to RECIST v. 1.1

4. Age > 18 years

5. Performance status, PS=0, PS=1 or PS=2

6. Life expectancy > 3 months

7. Adequate bone marrow function

8. Leucocyte count > 2,5 * 109/L

9. Granulocyte count > 1,5 * 109/L

10. Thrombocyte count > 100 * 109/l

11. Creatinine < 2,5 * UNL 130 micromol/L

12. Adequate liver function

13. ASAT < 100 U/L

14. Bilirubin < 300 U/L

15. S-hCG negative (fertile women)

16. Written informed consent

17. Inclusion at least 4 weeks after major abdominal surgery

18. If radiotherapy for brain metastases prior to inclusion, then progressive disease
proven by new brain MR-scan before inclusion

Exclusion Criteria:

1. Treatment with immune suppressors (ie. prednisone) not allowed

2. Other malignancies 3 years prior to inclusion except benign skin lesions

3. Severe medical condition, severe asthma, severe COL, severe heart- or diabetic disease

4. Acute/Chronic infection with HIV, hepatitis or tuberculosis

5. Known severe allergic reactions

6. Former anaphylactic reactions

7. Active autoimmune diseases

8. Pregnant or nourishing women

9. Psychiatric disease resulting in non-compliance

10. Known allergic reactions towards Montanide, Imiquimod, Temozolomide or Leukine

11. Simultaneously treatment with other experimental drugs

Patients cannot be treated with chemotherapy, radiotherapy (except locally) or
immunotherapy 14 days within inclusion.