Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Inge Marie Svane
With
Copenhagen University Hospital at Herlev
Secondarily to studying the efficacy of the treatment; the investigators examine if treatment with IDO/Survivin peptide can induce a measurable cellular T-cell response when the vaccine is given in combination with temozolomide treatment for melanoma patients.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | Peptide Vaccine and Temozolomide for Metastatic Melanoma Patients
