Brain MetastasisNCT01727531
IDO2 Genetic Status Informs the Neoadjuvant Efficacy of Chloroquine (CQ) in Brain Metastasis Radiotherapy
A study testing Chloroquine diphosphate in people with Brain Metastasis, run by Main Line Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastasis
- What is being tested?
- Chloroquine diphosphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
About this study
Official title: IDO2 Genetic Status Informs the Neoadjuvant Efficacy of Chloroquine in Brain Metastasis Radiotherapy.
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.
Read the 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.
- Conditions
- Brain Metastasis
- Being tested
- Chloroquine diphosphate
- Keywords
- chloroquine, WBRT, survival, brain metastasis, radiotherapy, SNPs, gene coding, immunoregulatory enzyme IDO2
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chloroquine diphosphateDrug
250 mg chloroquine once a day by mouth beginning one week prior to beginning radiation therapy and continue for a total of five weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Chloroquine diphosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific Aim
Determine patients physical profiles prior WBRT and at regular intervals afterwards up to 24 months after radiotherapy
Measured: up to 24-months after completion of treatment
Secondary outcomes (1)
Secondary endpoint: death
from any cause
Measured: up to 24 months after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2012 (estimated)
- Study startDec 2008
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Main Line Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albert DeNittis, Main Line Health
- Investigators
- Albert DeNittis, MD, Principal investigator, Main Line Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727531
- Sponsor's protocol ID
- R09-2775L
- Status last verified
- Apr 2015
- First submitted
- 7 Nov 2012
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IDO2 Genetic Status Informs the Neoadjuvant Efficacy of Chloroquine in Brain Metastasis Radiotherapy.
- ClinicalTrials.gov ID
- NCT01727531
- Acronym / sponsor ID
- R09-2775L
- Conditions
- Brain Metastasis
- Keywords
- chloroquine, WBRT, survival, brain metastasis, radiotherapy, SNPs, gene coding, immunoregulatory enzyme IDO2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Main Line HealthUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 16 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CQ Arm | Experimental | Drug: Chloroquine diphosphate250 mg chloroquine once a day by mouth beginning one week prior to beginning radiation therapy and continue for a total of five weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chloroquine diphosphate250 mg chloroquine once a day by mouth beginning one week prior to beginning radiation therapy and continue for a total of five weeks | Drug | CQ Arm |
Primary outcome
Specific Aim
Time frame: up to 24-months after completion of treatment
Determine patients physical profiles prior WBRT and at regular intervals afterwards up to 24 months after radiotherapy
1 secondary outcome
Secondary endpoint: death
Time frame: up to 24 months after completion of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert DeNittis, MD principal investigator
Main Line Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chloroquine diphosphate in people with Brain Metastasis, run by Main Line Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specific Aim (time frame: up to 24-months after completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2015.