← Back to Search

Alkylating agents

Exablate BBBD + Carboplatin for Glioblastoma

Phase 1 & 2

Waitlist Available

Research Sponsored by InSightec

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Planned for Carboplatin monotherapy

Must be between 18-80 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 12 months

Awards & highlights

Study Summary

This trial is testing a new way to open the blood-brain-barrier to treat recurrent glioblastoma with carboplatin monotherapy.

Who is the study for?

This trial is for adults aged 18-80 with confirmed glioblastoma who are set to undergo Carboplatin therapy. They must not be pregnant, agree to use effective contraception, and have recovered from previous treatments' side effects. Exclusions include those with acute brain hemorrhage, prior carboplatin toxicity, other active cancers or infections, severe hypertension, bleeding disorders, known sensitivities to certain contrast agents or ultrasound components, inability to undergo MRI scans due to implants or renal dysfunction.Check my eligibility

What is being tested?

The study tests the safety of using the Exablate Model 4000 Type 2 system for opening the blood-brain barrier in recurrent glioblastoma patients receiving Carboplatin chemotherapy. The goal is to see if this method can improve treatment delivery directly into the brain tumor area.See study design

What are the potential side effects?

Potential side effects may include reactions related to disrupting the blood-brain barrier such as temporary neurological changes (headache or seizure), issues from Carboplatin like nausea and low blood counts, and possible allergic reactions to contrast agents used during imaging procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for treatment with Carboplatin alone.

Select...

I am between 18 and 80 years old.

Select...

I have recovered from major side effects of my previous treatments.

Select...

My cancer has worsened after initial chemo and radiation treatment.

Select...

My diagnosis is glioblastoma confirmed by tissue analysis.

Select...

I am not pregnant and use effective birth control methods.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse events

Contrast intensity on MR imaging

Side effects data

From 2008 Phase 2 trial • 149 Patients • NCT02004093

59%

Nausea

59%

Diarrhoea

48%

Neutropenia

40%

Fatigue

32%

Vomiting

29%

Alopecia

27%

Constipation

25%

Decreased appetite

25%

Anaemia

24%

Abdominal pain

23%

Rash

21%

Headache

19%

Epistaxis

15%

Drug hypersensitivity

15%

Arthralgia

15%

Thrombocytopenia

15%

Neuropathy peripheral

13%

Dysgeusia

13%

Stomatitis

12%

Asthenia

12%

Dizziness

12%

Dyspepsia

12%

Leukopenia

11%

Dyspnoea

11%

Nail disorder

11%

Peripheral sensory neuropathy

Mucosal inflammation

Pruritus

Muscle spasms

Cystitis

Insomnia

Hemorrhoids

Back pain

Hypertension

Pain in extremity

Urinary tract infection

Cough

Musculoskeletal pain

Flushing

Myalgia

Erythema

Bone pain

Nasopharyngitis

Abdominal pain upper

Chest pain

Pyrexia

Dry skin

Lethargy

Paraesthesia

Abdominal pain lower

Vaginal discharge

Oedema peripheral

Phlebitis

Intestinal obstruction

Ascites

Gastrointestinal haemorrhage

Abdominal distension

Local swelling

Pulmonary embolism

Diaphragmatic hernia

Cardiac failure congestive

Hepatic lesion

Blood glucose increased

Lower respiratory tract infection

Pneumonia

Syncope

Ileus paralytic

Left ventricular dysfunction

100%

80%

60%

40%

20%

Study treatment Arm

Chemotherapy + Pertuzumab

Chemotherapy

Trial Design

1Treatment groups

Experimental Treatment

Group I: Exablate BBBD with carboplatinExperimental Treatment2 Interventions

Carboplatin will be administered via IV infusion about every 4 weeks for up to 6 cycles. The dosage will be calculated based on subject's creatinine level. On the day of planned carboplatin therapy, subjects will undergo Exablate procedure to open the blood-brain-barrier in the targeted cancerous brain areas prior to Carboplatin administration.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6670

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

InSightecLead Sponsor

89 Previous Clinical Trials

3,684 Total Patients Enrolled

7 Trials studying Glioblastoma

128 Patients Enrolled for Glioblastoma

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04417088 — Phase 1 & 2

Glioblastoma Research Study Groups: Exablate BBBD with carboplatin

Glioblastoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04417088 — Phase 1 & 2

Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04417088 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the eligibility for this trial restricted to individuals under 30 years of age?

"This research project requires that volunteers are between 18 to 80 years old. There 97 trials available for minors, and 1068 clinical programs designed for individuals aged 65 or older."

Answered by AI

Are there any openings for participants in this research endeavor?

"Data on clinicaltrials.gov suggests that recruitment for this medical trial is ongoing, with the initial post being made on November 6th 2020 and the last update occurring in late November 2021."

Answered by AI

How many venues are currently conducting this experiment?

"The University of Maryland in Baltimore, Brigham and Women's Hospital in Boston, and Stanford University in Palo Alto are three locations where patients can enroll for this trial. Additionally, 4 other medical sites offer enrollment as well."

Answered by AI

What is the upper limit of participants for this investigation?

"To launch the clinical trial, InSightec requires 30 individuals that meet its criteria. The sponsor has multiple sites for conducting this study such as University of Maryland in Baltimore and Brigham and Women's Hospital in Boston."

Answered by AI

What other studies have utilized Exablate BBBD as part of their methodology?

"The earliest known clinical trial involving Exablate BBBD occurred in 2002, at the Health Central de Asturias. As of now, 834 trials have been completed while 702 are actively enrolling patients; particularly concentrated within Baltimore."

Answered by AI

Am I eligible to participate in this clinical trial?

"To qualify for participation in this clinical trial, potential participants must have glioblastoma and be between 18-80 years of age. The recruitment goal is currently set at 30 individuals."

Answered by AI

What medical condition is Exablate BBBD employed to alleviate?

"Exablate BBBD is predominantly employed to treat lymphoma and non-Hodgkin's maladies. Nonetheless, it can be put into practice for more serious conditions such as advanced sarcoma, initial treatment of cancerous growths, and Hodgkin afflictions."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Exablate Blood-Brain Barrier Disruption for the Treatment of rGBM in Subjects Undergoing Carboplatin Monotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04417088.

All > Glioblastoma Boston