IDO2 Genetic Status Informs the Neoadjuvant Efficacy of Chloroquine in Brain Metastasis Radiotherapy.
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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Albert DeNittis, MD
Principal Investigator
Main Line Health
United States: Federal Government
R09-2775L
NCT01727531
December 2008
December 2020
Name | Location |
---|---|
Lankenau Medical Center | Wynnewood, Pennsylvania 19096 |