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

Brain Metastasis Clinical Trial

Official title:

IDO2 Genetic Status Informs the Neoadjuvant Efficacy of Chloroquine in Brain Metastasis Radiotherapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01727531
• Other study ID #: R09-2775L
• Status: Completed
• Phase: N/A
• First received: November 7, 2012
• Last updated: April 7, 2015
• Start date: December 2008
• Est. completion date: August 2013

Study information

• Verified date: April 2015
• Source: Main Line Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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:

1. Determine patients physical profiles prior WBRT and at regular intervals afterwards up to 24 months after radiotherapy.

2. Record the status of patient metastases (i.e. number, location, size)

3. Determine patients' KPS values.

4. Record the incidence and causes of mortality of patients.

5. Determine the genotype of IDO2 for each patient.

6. Following data analysis, test the validity of the two hypotheses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Metastasis
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

Drug:
• Chloroquine diphosphate
250 mg chloroquine once a day by mouth beginning one week prior to beginning radiation therapy and continue for a total of five weeks

Locations

Country	Name	City	State
United States	Lankenau Medical Center	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Main Line Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Additional Aims	Record the status of patient metastases (i.e. number, location, size)	up to 24 months after completion of treatment	No
Other	Additional Aims	Record KPS	up to 24 months after completion of treatment	No
Other	Additional Aims	Record genotype of IDO2	up to 24 months after completion of treatment	No
Primary	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	No
Secondary	Secondary endpoint: death	from any cause	up to 24 months after completion of treatment	No