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ATM Inhibitor
ATM-Inhibitor + Radiation for Brain Tumor
Phase 1
Recruiting
Led By William G. Breen, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks after last day of rt (up to 60 days)
Awards & highlights
Study Summary
This trial is testing a new drug to treat brain tumors that have come back after radiation therapy.
Who is the study for?
Adults over 18 with recurrent brain tumors, specifically Glioblastoma or Grade 3/4 astrocytoma, who've had prior radiation and chemo. They must be able to take light-protective measures, provide tissue samples for research, have a life expectancy of at least 3 months, and meet certain health criteria like adequate blood counts and liver function. Pregnant or nursing individuals and those not using contraception are excluded.Check my eligibility
What is being tested?
The trial is testing WSD0628 combined with radiation therapy on patients with recurrent brain tumors to see if it's effective. Participants will receive the ATM-Inhibitor drug alongside standard radiation treatments.See study design
What are the potential side effects?
Potential side effects of WSD0628 may include risks associated with light sensitivity requiring protective measures during treatment, possible organ-specific inflammation due to the drug's action on cellular repair mechanisms, as well as general side effects from chemotherapy such as fatigue, digestive issues or blood-related complications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks after last day of rt (up to 60 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks after last day of rt (up to 60 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the maximum tolerated dose of WSD0628 in combination with radiation therapy for patients with recurrent high-grade glioma.
Determine the recommended phase 2 dose of WSD0628 in combination with radiation therapy for patients with recurrent high-grade glioma.
Secondary outcome measures
Assess anti-tumor activity of WSD0628 delivered concurrently with radiation, including intracranial overall response rate (ORR)
Assess anti-tumor activity of WSD0628 delivered concurrently with radiation, including progression-free survival (PFS)
Assess anti-tumor activity of WSD0628 delivered concurrently with radiation, including volumetric change in tumor size
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Group C (Tumor Penetrance Treatments)Experimental Treatment1 Intervention
One treatment of WSD0628 will be given prior to radiation and surgical resection will be performed on the same day. The two doses given will be determined by Group A and Group B. Patients will be randomized in a 1:1 fashion.
Dose level 1: minimally radiosensitizing concentration of WSD0628 will be achieved.
Dose level 2: selected based on a prediction that a maximally radiosensitizing concentration of WSD0628 will be achieved.
This portion of the study will open after Group A (Dose Escalation) is complete. This portion of the study will open to patients with recurrent high-grade glioma to further evaluate the efficacy, safety, tolerability, pharmacokinetics and biological activity of WSD0628 when combined with radiation therapy in specific patient subgroups
Group II: Group B (Dose Expansion)Experimental Treatment1 Intervention
WSD0628 treatment should be started the day before radiation therapy starts (Day 1). Radiation therapy is given for 10 consecutive business days (Day 2-15, not including weekends and holidays), and WSD0628 will only be given on those 10 consecutive business days ≥30 minutes but ≤2 hours before radiation.
The Group B (Dose Expansion) portion of the study will be opened after the Group A (Dose Escalation) is complete.
Group III: Group A (Dose Escalation)Experimental Treatment1 Intervention
WSD0628 treatment should be started the day before radiation therapy starts (Day 1). Radiation therapy is given for 10 consecutive business days (Day 2-15, not including weekends and holidays), and WSD0628 will only be given on those 10 consecutive business days ≥30 minutes but ≤2 hours before radiation.
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Who is running the clinical trial?
Food and Drug Administration (FDA)FED
174 Previous Clinical Trials
1,333,625 Total Patients Enrolled
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Mayo ClinicLead Sponsor
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3,783,385 Total Patients Enrolled
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732 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,719 Previous Clinical Trials
40,963,466 Total Patients Enrolled
324 Trials studying Glioblastoma
23,105 Patients Enrolled for Glioblastoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am willing to protect myself from light during and two weeks after the study.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I have a long QT interval or risk factors for Torsades de Pointes.I haven't taken seizure medications or more than 8 mg of steroids daily in the last two weeks.I have had lung conditions that needed steroid treatment.I haven't had radiation in the last 6 months or recent drug treatments.I do not have uncontrolled high blood pressure, severe brain injury, or stroke, and I am not on any experimental treatments.I have not had a heart attack in the last 6 months and do not need ongoing therapy for severe heart rhythm problems.I am not willing to use birth control during the trial.I am in Group C, scheduled for brain surgery and targeted radiation as part of my treatment.My brain tumor is confirmed as Glioblastoma or Grade 3/4 astrocytoma.I can't control my nausea with medication, have chronic stomach issues, trouble swallowing pills, or had a major gut surgery affecting medicine absorption.I can take care of myself and perform daily activities.My glioma has worsened despite radiation and chemotherapy.I have a bleeding disorder or a history of significant bleeding.
Research Study Groups:
This trial has the following groups:- Group 1: Group A (Dose Escalation)
- Group 2: Group B (Dose Expansion)
- Group 3: Group C (Tumor Penetrance Treatments)
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.
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