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Alkylating agents
Ultrasound-assisted Chemotherapy for Glioblastoma (SC9/ABX Trial)
Phase 1 & 2
Recruiting
Led By Adam M Sonabend, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
WHO performance status ≤ 2 (equivalent to Karnofsky Performance Status (KPS) of ≥70)
Measurable or evaluable disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 years
Awards & highlights
SC9/ABX Trial Summary
This trial will test a new way of giving the chemotherapy drug paclitaxel to people with glioblastoma that has come back after surgery. In this trial, they will give the drug through a device that uses ultrasound to open the blood brain barrier for a short time so that the drug can get into the brain.
Who is the study for?
Adults over 18 with a specific type of brain cancer called IDH1 wild-type glioblastoma, who are fit for surgery and have had up to two prior treatments. They must not be pregnant, agree to use contraception, and have stable vital organ functions. Excluded are those with uncontrolled epilepsy, certain allergies or medical conditions that conflict with the trial's procedures.Check my eligibility
What is being tested?
The trial tests if using ultrasound to open the blood-brain barrier before giving chemotherapy (albumin-bound paclitaxel followed by carboplatin) can safely improve treatment outcomes in recurrent glioblastoma patients. The study will determine safe dosages and measure how well this method delivers chemo into the tumor.See study design
What are the potential side effects?
Potential side effects include reactions related to albumin-bound paclitaxel or carboplatin such as allergic responses, nerve damage symptoms like numbness or tingling, bone marrow suppression leading to low blood cell counts, liver or kidney function changes, and fatigue.
SC9/ABX Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mostly able to care for myself and carry out daily activities.
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My cancer can be measured or seen on tests.
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I am eligible for surgery to remove part of my tumor.
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My glioblastoma does not have the IDH1 mutation and is grade 4.
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My tumor is 70 mm or smaller on an MRI before surgery.
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My cancer has grown despite 1-2 previous treatments.
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I am 18 years old or older.
SC9/ABX Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
1-year survival rate (Phase 2)
Dose limiting toxicity (Phase1)
Relationship between overall survival and SSR3 (Phase 2)
Secondary outcome measures
Incidence of side effects/toxicity associated with Sonication/ABX treatment
Other outcome measures
Extent of tumor and peritumoral tissue covered by BBB opening
Measurement of circulating tumor DNA, methods and units for this measure are to be determined and still under evaluation.
Objective response rate (RANO)
SC9/ABX Trial Design
1Treatment groups
Experimental Treatment
Group I: SC9/ABX (phase 1); SC9/ABX/Carboplatin (phase 2)Experimental Treatment3 Interventions
Infusion of albumin-bound paclitaxel immediately followed by sonication using the SC9 device and microbubbles in order to open the blood-brain barrier in phase 1. In phase 2, patients will receive carboplatin immediately prior to sonication using the SC9 device and microbubbles in order to open the blood-brain barrier, then will receive albumin-bound paclitaxel upon completion of sonication.
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,174 Total Patients Enrolled
11 Trials studying Glioblastoma
381 Patients Enrolled for Glioblastoma
CarTheraIndustry Sponsor
5 Previous Clinical Trials
657 Total Patients Enrolled
3 Trials studying Glioblastoma
623 Patients Enrolled for Glioblastoma
Bristol-Myers SquibbIndustry Sponsor
2,639 Previous Clinical Trials
4,128,943 Total Patients Enrolled
19 Trials studying Glioblastoma
2,759 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- It has been over 12 weeks since I finished my radiation therapy.I cannot take Abraxane or carboplatin due to health reasons.I am allergic to or have had reactions to drugs similar to paclitaxel or carboplatin.You have problems with controlling your body temperature or feeling changes in temperature caused by a medical device.I am mostly able to care for myself and carry out daily activities.I have epilepsy that isn't well-controlled or need specific epilepsy drugs.My cancer can be measured or seen on tests.I am eligible for surgery to remove part of my tumor.I am on a stable or decreasing dose of dexamethasone under 6 mg for mass effect.My glioblastoma does not have the IDH1 mutation and is grade 4.I do not have severe heart or lung conditions.My liver, kidney, and bone marrow are functioning well, as shown by recent tests.My tumor is 70 mm or smaller on an MRI before surgery.My cancer has grown despite 1-2 previous treatments.You have a risk of the wound in your head opening up.I need to keep taking my blood thinner medication.I am allergic to ingredients in the Definity ultrasound contrast agent.I agree to use birth control during and up to 6 months after the study.My tumor is located in the back part of my brain.You have taken any experimental medications within the past month.I have had cancer within the last 3 years.I am 18 years old or older.Your disease is spread out in different areas of your body and cannot be fully seen in ultrasound images if the areas are more than 70 millimeters apart.
Research Study Groups:
This trial has the following groups:- Group 1: SC9/ABX (phase 1); SC9/ABX/Carboplatin (phase 2)
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Have any other studies been conducted with Chemotherapy, albumin-bound paclitaxel?
"At present, 856 clinical trials are being conducted to research Chemotherapy, albumin-bound paclitaxel. Of these active studies, 231 are in the third phase of development. Although a majority of them originate from Westmead, New South Wales, there is a total of 45936 sites that oversee this medication's testing."
Answered by AI
Are there still opportunities for volunteers to join this clinical trial?
"Per information available on clinicaltrials.gov, this medical experiment is actively in search of participants. The initial announcement was made October 29th 2020 and the trial details were last revised on November 11th 2022."
Answered by AI
What maladies is Chemotherapy, albumin-bound paclitaxel typically administered for?
"Chemotherapy, albumin-bound paclitaxel is typically used to address hypoalbuminemia. Additionally, this medication can be employed in the treatment of apn, shock states, hypovolemic episodes and locally advanced non-small cell lung cancer."
Answered by AI
How many participants can join this experiment?
"Affirmative. Clinicaltrials.gov reports that this research initiative, which was first published on October 29th 2020, is still accepting patients. 57 participants need to be enrolled from a single medical centre."
Answered by AI
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