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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

Must not have

Medical contraindications to Abraxane® or carboplatin

Have received prior therapy with or have history of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel or carboplatin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 years

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot take Abraxane or carboplatin due to health reasons.

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I am allergic to or have had reactions to drugs similar to paclitaxel or carboplatin.

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I have epilepsy that isn't well-controlled or need specific epilepsy drugs.

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I do not have severe heart or lung conditions.

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I am allergic to ingredients in the Definity ultrasound contrast agent.

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My tumor is located in the back part of my brain.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

1-year survival rate (Phase 2)

Dose limiting toxicity (Phase1)

Relationship between overall survival and SSR3 (Phase 2)

Secondary study objectives

Incidence of side effects/toxicity associated with Sonication/ABX treatment

Other study objectives

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)

Awards & Highlights

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.

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.

0 / 13Eligibility criteria met