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


N/A
18 Years
N/A
Open (Enrolling)
Both
Brain Metastasis

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Specific Aim

Outcome Description:

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

Outcome Time Frame:

up to 24-months after completion of treatment

Safety Issue:

No

Principal Investigator

Albert DeNittis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Main Line Health

Authority:

United States: Federal Government

Study ID:

R09-2775L

NCT ID:

NCT01727531

Start Date:

December 2008

Completion Date:

December 2020

Related Keywords:

  • Brain Metastasis
  • chloroquine
  • WBRT
  • survival
  • brain metastasis
  • radiotherapy
  • SNPs
  • gene coding
  • immunoregulatory enzyme IDO2
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Brain Neoplasms

Name

Location

Lankenau Medical CenterWynnewood, Pennsylvania  19096