Clinical trial NCT01543464: Peptide Vaccine and Temozolomide for Metastatic Melanoma Patients
Official title: Combination of IDO/Survivin Peptide Vaccine, GM-CSF, Imiquimod and Temozolomide Chemotherapy for Patients With Metastatic Malignant Melanoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Malignant Melanoma
Keywords: Indeolamine 2,3 dioxygenase
Survivin
Montanide
Imiquimod
GMCSF
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: Copenhagen University Hospital at Herlev
First posted: 2012-03-05
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Clinical benefit rate (CBR)
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brønshøj
country: Denmark
facility: Trine Zeeberg Iversen
state: Copenhagen
Study officials:
affiliation: Center for Cancer ImmuneTherapy
name: Trine Zeeberg Iversen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Cancer ImmunoTherapy
name: Inge Marie Svane, MD, PhD, Prof.
role: STUDY_DIRECTOR
References: