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Alkylating agents
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
Must be between 18-80 years old
Recovered to grade 0 or 1 or pre-treatment baseline from clinically significant toxic effects of prior therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 12 months
Awards & highlights
Study Summary
This trial is testing whether a device that opens the blood-brain-barrier is safe and feasible for treating recurrent glioblastoma with carboplatin monotherapy.
Who is the study for?
This trial is for adults aged 18-80 with recurrent glioblastoma who are planning to undergo carboplatin monotherapy. Participants must have recovered from previous treatments, not be pregnant or breastfeeding, use effective contraception, and be able to give consent. Exclusions include certain heart conditions, bleeding disorders, severe kidney issues, active infections or other cancers requiring treatment.Check my eligibility
What is being tested?
The study tests the safety of using the Exablate Model 4000 Type 2 system to temporarily open the blood-brain barrier in patients with recurrent glioblastoma during carboplatin chemotherapy. The goal is to see if this method can improve treatment delivery directly to brain tumors.See study design
What are the potential side effects?
Potential side effects may include discomfort from lying still during MRI scans used in the procedure and reactions related to carboplatin such as nausea, low blood counts leading to increased infection risk, hair loss and nerve damage causing numbness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 80 years old.
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I have recovered from major side effects of my previous treatments.
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My diagnosis is glioblastoma confirmed by tissue analysis.
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My cancer has worsened after the first treatment.
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I am scheduled for treatment with Carboplatin alone.
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I can speak and communicate verbally.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Magnetic Resonance Imaging
Occurrence of Adverse Events
Side effects data
From 2008 Phase 2 trial • 149 Patients • NCT0200409359%
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
9%
Mucosal inflammation
9%
Pruritus
9%
Muscle spasms
9%
Cystitis
8%
Insomnia
8%
Hemorrhoids
8%
Back pain
8%
Hypertension
8%
Pain in extremity
8%
Urinary tract infection
7%
Cough
7%
Musculoskeletal pain
7%
Flushing
7%
Myalgia
7%
Erythema
7%
Bone pain
7%
Nasopharyngitis
7%
Abdominal pain upper
7%
Chest pain
7%
Pyrexia
5%
Dry skin
5%
Lethargy
5%
Paraesthesia
5%
Abdominal pain lower
5%
Vaginal discharge
5%
Oedema peripheral
4%
Phlebitis
3%
Intestinal obstruction
1%
Ascites
1%
Gastrointestinal haemorrhage
1%
Abdominal distension
1%
Local swelling
1%
Pulmonary embolism
1%
Diaphragmatic hernia
1%
Cardiac failure congestive
1%
Hepatic lesion
1%
Blood glucose increased
1%
Lower respiratory tract infection
1%
Pneumonia
1%
Syncope
1%
Ileus paralytic
1%
Left ventricular dysfunction
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
InSightecLead Sponsor
89 Previous Clinical Trials
3,701 Total Patients Enrolled
7 Trials studying Glioblastoma
145 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My diagnosis is glioblastoma confirmed by tissue analysis.I am not pregnant or breastfeeding.I am not pregnant and use effective birth control methods.I am between 18 and 80 years old.I have recovered from major side effects of my previous treatments.My cancer has worsened after the first treatment.My cancer is located in my cerebellum, spinal cord, or brain stem.I have had a recent bleeding in my brain.You have metal objects implanted in your head or brain.You have a known sensitivity or medical reasons that prevent you from using ultrasound contrast agent or perflutren.I have very high blood pressure.I have an active Hepatitis B, Hepatitis C, or HIV infection.You have severe depression that is not well managed with treatment.You are allergic or have a bad reaction to gadolinium-based contrast agents.I have another cancer that is getting worse or needs treatment.I am scheduled for treatment with Carboplatin alone.You have a specific type of heart condition where blood flows abnormally between the right and left sides of your heart.I have a history of bleeding disorders or my tumor has bled on its own.I am currently on antibiotics for a cranial or systemic infection.I cannot lie on my back or have severe claustrophobia that medication can't help.I can speak and communicate verbally.My kidneys do not work well.You currently have a problem with using drugs or alcohol.I have heart disease or unstable blood pressure and heart rate.I have experienced side effects from carboplatin chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Exablate BBBD with carboplatin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the cap for enrollees in this clinical trial?
"Affirmative, the information accessible on clinicaltrials.gov indicates that this health trial is currently recruiting participants. It was initially published in October 2020 and most recently modified in December 2021; it requires 50 individuals to be recruited at one medical centre."
Answered by AI
Are researchers seeking out new participants for this experiment?
"Affirmative. Clinicaltrials.gov data reveals that this study, which was first made available on October 13th 2020, is looking for participants to enrol in the trial. The research necessitates 50 individuals at a single medical centre."
Answered by AI
How can I become involved in this scientific investigation?
"This clinical trial is seeking 50 individuals aged between 18 and 80 who have glioblastoma. Other essential requirements for all applicants include verbal communicative ability, recovery from prior treatment's toxic side effects (at grade 0 or 1), and having an age within the specified range."
Answered by AI
Are minors being considered for enrolment in this experiment?
"The eligibility criteria for this study necessitates that all participants should be below 80 years of age and over the age of majority."
Answered by AI
What ailments has Exablate BBBD been found to be effective in treating?
"Exablate BBBD is a popularly employed treatment for lymphoma and non-hodgkin, as well as more advanced sarcomas. This therapeutic intervention can also be utilized to treat hodgkin disease in its infancy."
Answered by AI
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