IDO2 Genetic Status Informs the Neoadjuvant Efficacy of C... | NCT01727531

Studies
IDO2 Genetic Status Informs the Neoadjuvant Efficacy of Chloroquine (CQ) in Brain Metastasis Radiotherapy

NCT01727531

Sponsor

Main Line Health

Status

Completed

Last Update Posted

Apr 8, 2015Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Brain Metastasis

Interventions

Chloroquine diphosphate

Countries

United States

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

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Aug 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

Nov 7, 2012

First Submission Date that Met QC Criteria

Nov 15, 2012

First Posted Date

Nov 16, 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

Apr 7, 2015

Last Update Posted Date

Apr 8, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

This research is being done to determine if a short course of Chloroquine (five weeks) before, during and after whole brain radiation therapy (WBRT) will improve the overall survival of subjects being treated for brain metastases.

Detailed Description

Hypothesis one: A short course of chloroquine one week prior and four weeks after initiation of WBRT is tolerable and significantly increases the median survival time of patients suffering from brain metastasis as assessed one, three, six, nine, twelve and 24 months post radiotherapy, when compared to historic controls.

Hypothesis two: The presence of one or both single-nucleotide polymorphisms (SNP)s in the gene coding for the immunoregulatory enzyme indoleamine 2,3-dioxygenase 2 (IDO2) improves the clinical outcomes of WBRT or the response to CQ co-treatment.

3.2. Specific Aims:

The specific aims of this study are:

Determine patients physical profiles prior WBRT and at regular intervals afterwards up to 24 months after radiotherapy.
Record the status of patient metastases (i.e. number, location, size)
Determine patients' KPS values.
Record the incidence and causes of mortality of patients.
Determine the genotype of IDO2 for each patient.
Following data analysis, test the validity of the two hypotheses.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CQ Arm	Experimental	250 mg chloroquine once a day by mouth beginning one week prior to beginning radiation therapy and continue for a total of five weeks.	Drug: Chloroquine diphosphate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chloroquine diphosphate	Drug	250 mg chloroquine once a day by mouth beginning one week prior to beginning radiation therapy and continue for a total of five weeks	CQ Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Specific Aim	Determine patients physical profiles prior WBRT and at regular intervals afterwards up to 24 months after radiotherapy	up to 24-months after completion of treatment

Secondary Outcomes

Measure	Description	Time Frame
Secondary endpoint: death	from any cause	up to 24 months after completion of treatment

Other Outcomes

Measure	Description	Time Frame
Additional Aims	Record the status of patient metastases (i.e. number, location, size)	up to 24 months after completion of treatment
Additional Aims	Record KPS

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with histologically confirmed primary solid malignancy
Patients with single or multiple brain metastases
Patients with metastasis diameter < 5 cm
Age > 18
Clearance from the patient's physician that treatment with chloroquine should not pose a problem to the patient

Exclusion Criteria:

Patients with a history of hypotension, cardiomyopathy, epilepsy, seizures
Patients with impaired renal function
Patients with psoriasis, porphyria
Patients with known hypersensitivity to 4-aminoquinoline compounds
Pregnancy, nursing
Prior radiotherapy
During the chloroquine treatment, patients complaining from visual or auditory disturbances, and patients suffering from acute gastrointestinal problems i.e. Anorexia, nausea, vomiting, diarrhea, abdominal cramps

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Albert DeNittis, MD	Main Line Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lankenau Medical Center		Wynnewood	Pennsylvania	19096	United States

Condition Browse Module

MeSH Terms

ID	Term
D001932	Brain Neoplasms

Ancestor Terms

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C023676	chloroquine diphosphate

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided