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Peptide Vaccine and Temozolomide for Metastatic Melanoma Patients

Primary Purpose

Malignant Melanoma

Status

Terminated

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

Chemotherapy: Temozolomide

About this trial

This is an interventional treatment trial for Malignant Melanoma focused on measuring Indeolamine 2,3 dioxygenase, Survivin, Montanide, Imiquimod, GMCSF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histological verified malignant melanoma
Metastatic disease (brain metastasis allowed if asymptomatic)
Evaluable disease recording to RECIST v. 1.1
Age > 18 years
Performance status, PS=0, PS=1 or PS=2
Life expectancy > 3 months
Adequate bone marrow function
Leucocyte count > 2,5 * 109/L
Granulocyte count > 1,5 * 109/L
Thrombocyte count > 100 * 109/l
Creatinine < 2,5 * UNL 130 micromol/L
Adequate liver function
ASAT < 100 U/L
Bilirubin < 300 U/L
S-hCG negative (fertile women)
Written informed consent
Inclusion at least 4 weeks after major abdominal surgery
If radiotherapy for brain metastases prior to inclusion, then progressive disease proven by new brain MR-scan before inclusion

Exclusion Criteria:

Treatment with immune suppressors (ie. prednisone) not allowed
Other malignancies 3 years prior to inclusion except benign skin lesions
Severe medical condition, severe asthma, severe COL, severe heart- or diabetic disease
Acute/Chronic infection with HIV, hepatitis or tuberculosis
Known severe allergic reactions
Former anaphylactic reactions
Active autoimmune diseases
Pregnant or nourishing women
Psychiatric disease resulting in non-compliance
Known allergic reactions towards Montanide, Imiquimod, Temozolomide or Leukine
Simultaneously treatment with other experimental drugs

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

Sites / Locations

Trine Zeeberg Iversen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vaccine+adjuvants+temozolomide treatment

Arm Description

Experimental arm

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT01543464

First Posted

February 8, 2012

Last Updated

March 16, 2018

Sponsor

Inge Marie Svane

Collaborators

Copenhagen University Hospital at Herlev

1. Study Identification

Unique Protocol Identification Number

NCT01543464

Brief Title

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

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Terminated

Why Stopped

Diminished rectruitment

Study Start Date

May 2012 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Inge Marie Svane

Collaborators

Copenhagen University Hospital at Herlev

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Melanoma

Keywords

Indeolamine 2,3 dioxygenase, Survivin, Montanide, Imiquimod, GMCSF

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vaccine+adjuvants+temozolomide treatment

Arm Type

Experimental

Arm Description

Experimental arm

Intervention Type

Drug

Intervention Name(s)

Chemotherapy: Temozolomide

Intervention Description

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

Primary Outcome Measure Information:

Title

Clinical benefit rate (CBR)

Description

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).

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histological verified malignant melanoma Metastatic disease (brain metastasis allowed if asymptomatic) Evaluable disease recording to RECIST v. 1.1 Age > 18 years Performance status, PS=0, PS=1 or PS=2 Life expectancy > 3 months Adequate bone marrow function Leucocyte count > 2,5 * 109/L Granulocyte count > 1,5 * 109/L Thrombocyte count > 100 * 109/l Creatinine < 2,5 * UNL 130 micromol/L Adequate liver function ASAT < 100 U/L Bilirubin < 300 U/L S-hCG negative (fertile women) Written informed consent Inclusion at least 4 weeks after major abdominal surgery If radiotherapy for brain metastases prior to inclusion, then progressive disease proven by new brain MR-scan before inclusion Exclusion Criteria: Treatment with immune suppressors (ie. prednisone) not allowed Other malignancies 3 years prior to inclusion except benign skin lesions Severe medical condition, severe asthma, severe COL, severe heart- or diabetic disease Acute/Chronic infection with HIV, hepatitis or tuberculosis Known severe allergic reactions Former anaphylactic reactions Active autoimmune diseases Pregnant or nourishing women Psychiatric disease resulting in non-compliance Known allergic reactions towards Montanide, Imiquimod, Temozolomide or Leukine Simultaneously treatment with other experimental drugs Patients cannot be treated with chemotherapy, radiotherapy (except locally) or immunotherapy 14 days within inclusion.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Trine Zeeberg Iversen, MD

Organizational Affiliation

Center for Cancer ImmuneTherapy

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Inge Marie Svane, MD, PhD, Prof.

Organizational Affiliation

Center for Cancer ImmunoTherapy

Official's Role

Study Director

Facility Information:

Facility Name

Trine Zeeberg Iversen

City

Brønshøj

State/Province

Copenhagen

ZIP/Postal Code

2700

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

Peptide Vaccine and Temozolomide for Metastatic Melanoma Patients

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