A Proof-of-principle Study of Hyperbaric Oxygen as a Radiosensitizer Prior to Stereotactic Radiosurgery for Brain Metastases

Description

Patients with brain metastases who are candidates for treatment with stereotactic radiosurgery (SRS) are potential study participants. SRS delivers high-energy, precisely-focused radiation to each brain metastasis to shrink the tumor, and is the standard-of-care for patients with these tumors. Oxygen enhances the damaging effects of radiation on tumor cells. Hyperbaric oxygen (HBO) therapy increases oxygen levels in all kinds of tissues, including tumors. The purpose of this trial is to study whether it is feasible to treat patients with HBO just prior to receiving SRS, given the timing constraints of treating sequentially with HBO and then SRS. Patients will undergo HBO treatment followed by the placement of a Gill-Thomas-Cosman head frame then transported ,via stretcher, to receive SRS. The transfer and placement of the head frame needs to be completed within the 15minute time frame. The trial's secondary objectives are to determine whether it has any effects on outcomes and quality of life. As part of study participation patients will be asked to complete quality of life questionnaires as well as mini mental status questionnaires. These will be done prior to treatment and at follow up appointments throughout the next 3 years while participating in the study. Patients will be given the option to participate in the optional bio marker blood draw study which would require patients to have blood drawn at three time points, pre-treatment, the day after treatment and at their first follow up visit.

Study Start Date

May 2013

Estimated Completion Date

August 2016

Interventions

  • Other: Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO

Specialties

  • Surgery: Neurosurgery,Radiology/Diagnostics,Surgical Oncology
  • Neurology: Neurologic Oncology,Neuroradiology,Neurosurgery
  • Oncology: Neurologic Oncology,Radiation Oncology
  • Radiology: Interventional,Neuroradiology

MeSH Terms

  • Brain Neoplasms
  • Hyperbaric Oxygenation
  • Neoplasm Metastasis
  • Neurosurgery

Study ID

Dartmouth-Hitchcock Medical Center -- D12129

Status

Unknown

Trial ID

NCT01850563

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

22

Sponsor

Dartmouth-Hitchcock Medical Center

Inclusion Criteria

  • Metastatic brain tumor referred to radiation oncology for treatment
  • Size of the presenting metastatic lesion up to 4.5 cm diameter
  • Age > 18 years
  • Patients must give informed consent indicating they are aware of the investigational nature of this treatment
  • Karnofsky Performance Status > 70% (Zubrod score 0 to 1)
  • Women of childbearing potential must have a negative serum or urine pregnancy test prior to start of study therapy

Exclusion Criteria

    Patients with the following conditions are not eligible to participate in this trial:
  • Pregnant women or women of childbearing potential without adequate contraception
  • Evidence of pneumothorax o Untreated pneumothorax risks tension pneumothorax during ascent in HBO chamber
  • COPD with C02 retention o Such patients can develop respiratory depression as HBO reduces their hypoxemic drive
  • Uncontrolled seizure disorder o Note that patients on adequate antiepileptic medications may receive HBO
  • Claustrophobia resistant to medication o Pre-medication with anxiolytics is generally sufficient for almost all anxious patients undergoing HBO treatment
  • History of middle ear surgery o Failure to equalize pressure in the middle ear can cause displacement of middle ear structures with consequent hearing loss
  • History of bleomycin administration o HBO can exacerbate interstitial pneumonitis in such patients
  • Current cis-platinum chemotherapy (i.e. therapeutic levels in the bloodstream at the time of HBO therapy) o HBO can increase cytotoxicity of cis-platinum
  • Uncontrolled high blood pressure o HBO can increase systemic vascular resistance
  • Unstable angina or myocardial infarction within the previous 3 months o Increased afterload due to HBO can increase myocardial workload
  • Cardiac EF ? 35%
  • Pulmonary edema can arise with HBO in certain patients with severe heart failure
  • In patients with prior history of CHF, subsequent echocardiogram and ECG are required to establish EF>35%
  • Treatment with disulfiram o Disulfiram inhibits superoxide dismutase and is not approved for use concomitantly with hyperbaric oxygen therapy
  • Active drug/alcohol dependence or abuse
  • Lack of adequate social support structures, e.g. homelessness
  • Tumors with potential confounding results on serum marker studies
  • Small cell (neuroendocrine) carcinomas
  • Carcinoid tumors

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
DartmouthHitchcock - Lebanon, New Hampshire 105.5 miles Alan Hartford MD 603-650-6600 None

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.