Trial Search Results

Exablate Blood-Brain Barrier Disruption for the Treatment of rGBM in Subjects Undergoing Carboplatin Monotherapy

The purpose of this study is to test the safety and effectiveness of anew procedure, Exablate BBBD with MRgFUS, or MR-guided focusedultrasound, in cancer patients with people with recurrent brain tumorsand who have had surgical resection and chemotherapy. Participants willhave recently been diagnosed with recurrent glioblastoma (rGBM), and isbeing considered for receiving treatment with carboplatin. Clinicalstudies have shown that carboplatin may help in the treatment of rGBM inthe brain; however the blood-brain-barrier may limit the amount ofmedicine that can reach the brain tumor. By using Exablate BBBD inpatients with rGBM, researchers hope to deliver more of the chemotherapydrug to the exact location of the tumor, so that more tumor cells arekilled.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

InSightec

Intervention(s):

  • Drug: Carboplatin
  • Device: Exablate BBBD

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria:

   - Must be between 18-80 years old

   - Histologically confirmed glioblastoma

   - Planned for Carboplatin monotherapy

   - Be willing and able to provided written informed consent/asent

   - Tumor progression after first line chemo radiation

   - Recovered to grade 0 or 1 or pre-treatment baseline from clinically significant toxic
   effects of prior therapy

   - Women of childbearing potential is confirmed not pregnant. Male and Female subjects
   utilize highly effective contraception

   - Able to communicate verbally

Exclusion Criteria:

   - Acute intracranial hemorrhage

   - Ferrous metallic implanted objects in the skull or brain

   - Prior toxicity with carboplatin chemotherapy

   - Women who are pregnant or breastfeeding

   - Cerebellar spinal cord or brain stem tumor

   - Known active Hepatitis B or Hepatitis C or HIV

   - Significant depression not adequately controlled

   - Has previously received anti-VEGF or anti-VEGF agents like Avastin

   - Cardiac disease or unstable hemodynamics

   - Severe hypertension

   - History of a bleeding disorder, coagulopathy or with a history of spontaneous tumor
   hemorrhage

   - Active drug or alcohol use disorder

   - Known sensitivity to gadolinium-based contrast agents

   - Known sensitivity or contraindications to ultrasound contrast agent or perflutren

   - Unable to undergo MRI or contraindications to MRI such as non-MRI compatible implanted
   devices

   - Difficulty lying supine and still or severe claustrophobia which cannot be managed
   with medication

   - Severely impaired renal function

   - Right to left or bi-directional cardiac shunt

   - Cranial or systemic infection requiring antibiotics

   - Known additional malignancy that is progression or require active treatment

Ages Eligible for Study

18 Years - 80 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Hari Priya Yerraballa, MBBS
650-724-9363
Recruiting