Clinical trial NCT01727531: IDO2 Genetic Status Informs the Neoadjuvant Efficacy of Chloroquine (CQ) in Brain Metastasis Radiotherapy
Official title: IDO2 Genetic Status Informs the Neoadjuvant Efficacy of Chloroquine in Brain Metastasis Radiotherapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Metastasis
Keywords: chloroquine
WBRT
survival
brain metastasis
radiotherapy
SNPs
gene coding
immunoregulatory enzyme IDO2
Lead sponsor: Main Line Health
Sponsor class: OTHER
First posted: 2012-11-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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:

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.

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

Primary outcomes:
measure: Specific Aim
timeFrame: up to 24-months after completion of treatment
Secondary outcomes:
measure: Secondary endpoint: death
timeFrame: up to 24 months after completion of treatment
Other outcomes:
measure: Additional Aims
timeFrame: up to 24 months after completion of treatment
measure: Additional Aims
timeFrame: up to 24 months after completion of treatment
measure: Additional Aims
timeFrame: up to 24 months after completion of treatment
Locations:
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
Study officials:
affiliation: Main Line Health
name: Albert DeNittis, MD
role: PRINCIPAL_INVESTIGATOR
References: