Peptide Vaccine and Temozolomide for Metastatic Melanoma Patients

Malignant Melanoma Clinical Trial

Official title:

Combination of IDO/Survivin Peptide Vaccine, GM-CSF, Imiquimod and Temozolomide Chemotherapy for Patients With Metastatic Malignant Melanoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01543464
• Other study ID #: MM1120
• Status: Terminated
• Phase: Phase 2
• First received: February 8, 2012
• Last updated: March 16, 2018
• Start date: May 2012
• Est. completion date: September 2016

Study information

• Verified date: March 2018
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Denmark	Trine Zeeberg Iversen	Brønshøj	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Inge Marie Svane	Copenhagen University Hospital at Herlev

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical benefit rate (CBR)	Primary endpoint is clinical benefit rate defined as complete remission rate + partial response + stable disease for a minimum of 6 months plus assessment of time to progression (TTP).	18 months