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

This study is currently recruiting participants.
Verified November 2012 by Main Line Health
Sponsor:
Information provided by (Responsible Party):
Albert DeNittis, Main Line Health
ClinicalTrials.gov Identifier:
NCT01727531
First received: November 7, 2012
Last updated: November 15, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Brain Metastasis
 Drug: Chloroquine diphosphate

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: IDO2 Genetic Status Informs the Neoadjuvant Efficacy of Chloroquine in Brain Metastasis Radiotherapy.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Main Line Health:

Primary Outcome Measures:
  • Specific Aim [ Time Frame: up to 24-months after completion of treatment ] [ Designated as safety issue: No ]
    Determine patients physical profiles prior WBRT and at regular intervals afterwards up to 24 months after radiotherapy


Secondary Outcome Measures:
  • Secondary endpoint: death [ Time Frame: up to 24 months after completion of treatment ] [ Designated as safety issue: No ]
    from any cause


Other Outcome Measures:
  • Additional Aims [ Time Frame: up to 24 months after completion of treatment ] [ Designated as safety issue: No ]
    Record the status of patient metastases (i.e. number, location, size)

  • Additional Aims [ Time Frame: up to 24 months after completion of treatment ] [ Designated as safety issue: No ]
    Record KPS

  • Additional Aims [ Time Frame: up to 24 months after completion of treatment ] [ Designated as safety issue: No ]
    Record genotype of IDO2


Estimated Enrollment: 100
Study Start Date: December 2008
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CQ Arm
250 mg chloroquine once a day by mouth beginning one week prior to beginning radiation therapy and continue for a total of five weeks.
 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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01727531

Contacts
Contact: Albert DeNittis, MD 484-476-2436 DeNittisA@Mlhs.org
Contact: George C Prendergast, Ph.D. 484-476-8144 PrendergastG@mlhs.org

Locations
United States, Pennsylvania
Lankenau Medical Center Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Albert DeNittis, MD     484-476-2436     DeNittisA@Mlhs.org    
Contact: George C Prendergast, Ph.D.     484-476-8144     PrendergastG@mlhs.org    
Principal Investigator: Albert DeNittis, MD            
Sponsors and Collaborators
Main Line Health
Investigators
Principal Investigator: Albert DeNittis, MD Main Line Health
  More Information

No publications provided

Responsible Party: Albert DeNittis, Principal Investigator, Main Line Health
ClinicalTrials.gov Identifier: NCT01727531     History of Changes
Other Study ID Numbers: R09-2775L
Study First Received: November 7, 2012
Last Updated: November 15, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Main Line Health:
chloroquine
WBRT
survival
brain metastasis
 radiotherapy
SNPs
gene coding
immunoregulatory enzyme IDO2

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Chloroquine
Chloroquine diphosphate
Amebicides
 Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides

ClinicalTrials.gov processed this record on May 23, 2013