Peptide Vaccine and Temozolomide for Metastatic Melanoma... | NCT01543464

Studies
Peptide Vaccine and Temozolomide for Metastatic Melanoma Patients

NCT01543464

Sponsor

Inge Marie Svane

Status

Terminated

Last Update Posted

Mar 19, 2018Actual

Enrollment

41Actual

Phase

Phase 2

Conditions

Malignant Melanoma

Interventions

Chemotherapy: Temozolomide

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Diminished rectruitment

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Sep 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Feb 8, 2012

First Submission Date that Met QC Criteria

Mar 2, 2012

First Posted Date

Mar 5, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2018

Last Update Posted Date

Mar 19, 2018Actual

Name	Class
Copenhagen University Hospital at Herlev	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vaccine+adjuvants+temozolomide treatment	Experimental	Experimental arm	Drug: Chemotherapy: Temozolomide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chemotherapy: Temozolomide	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Trine Zeeberg Iversen, MD	Center for Cancer ImmuneTherapy	Principal Investigator
Inge Marie Svane, MD, PhD, Prof.	Center for Cancer ImmunoTherapy	Study Director

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type