Peptide Vaccine and Temozolomide for Metastatic Melanoma Patients

NCT ID: NCT01543464

Last Updated: 2018-03-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2016-09-30

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.

Conditions

Malignant Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vaccine+adjuvants+temozolomide treatment

Experimental arm

Group Type: EXPERIMENTAL

Chemotherapy: Temozolomide

Intervention Type: DRUG

Vaccine: 250 microgram IDO5 peptide + 250 microgram Survivin peptide + 500 microL Montanide every 2nd week Adjuvants: 75 microgram GM-CSF + 1 application Imiquimod every 2nd week

Interventions

Chemotherapy: Temozolomide

Vaccine: 250 microgram IDO5 peptide + 250 microgram Survivin peptide + 500 microL Montanide every 2nd week Adjuvants: 75 microgram GM-CSF + 1 application Imiquimod every 2nd week

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Copenhagen University Hospital at Herlev

OTHER

Sponsor Role: collaborator

Inge Marie Svane

OTHER

Sponsor Role: lead

Responsible Party

Inge Marie Svane

MD, PhD & Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Trine Zeeberg Iversen, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Cancer ImmuneTherapy

Inge Marie Svane, MD, PhD, Prof.

Role: STUDY_DIRECTOR

Center for Cancer ImmunoTherapy

Locations

Trine Zeeberg Iversen

Brønshøj, Copenhagen, Denmark

Countries

Denmark

Other Identifiers

MM1120

Identifier Type: -

Identifier Source: org_study_id