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Targeted Therapy
Individualized Therapy for Glioblastoma
Phase 1
Waitlist Available
Led By Jennifer Clarke, MD
Research Sponsored by Jennifer Clarke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation and for 3 months after completion of study drug administration
Patient age must be >= 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will test a new diagnostic tool to see if it can help improve treatment for patients with a type of brain cancer.
Who is the study for?
Adults over 18 with recurrent, surgically-removable glioblastoma or gliosarcoma can join this trial. They must have had prior standard GBM treatment, be in good physical condition (KPS score >=70), and expected to live at least 3 more months. Participants need proper organ function and agree to use contraception. Pregnant women, those with severe heart issues, other active cancers (except certain cases), HIV-positive individuals, or psychiatric illnesses that affect study compliance are excluded.Check my eligibility
What is being tested?
The trial is testing the feasibility of personalized therapy for adults with recurrent glioblastoma using the UCSF 500 Cancer Gene Panel from tumor tissue and blood samples. This genetic test aims to tailor targeted treatments based on individual cancer DNA changes.See study design
What are the potential side effects?
Since individualized therapies will vary based on genetic testing results, specific side effects cannot be listed universally; they will depend on each unique treatment plan developed for participants' specific genetic tumor profiles.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to use birth control during and for 3 months after the study.
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I am 18 years old or older.
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My glioblastoma or gliosarcoma has returned and can be surgically removed.
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My blood tests show enough white cells and platelets.
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My liver is functioning within the required limits.
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My kidney function is within the normal range.
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I am not pregnant.
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My heart functions well without significant limitations.
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I haven't had a heart attack or unstable chest pain in the last year.
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I am able to care for myself and perform normal activities with minimal assistance.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival at 9 months (OS)
Therapeutic procedure
Secondary outcome measures
Incidence of treatment-related Adverse Events (AEs)
Overall survival (OS)
Progression-Free Survival (PFS)
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Individualized therapyExperimental Treatment1 Intervention
Study treatment for a given patient will consist of a regimen chosen from agents implicated in critical molecular signaling pathways and/or from signature-based predictions of drug efficacy. All agents are listed in the current pharmacopoeia for human use, but will differ amongst individual subjects. The study treatment will consist of up to 4 FDA approved drugs that have known dosing. This study is not only looking at 4 drugs. It is selecting up to 4 drugs per patient but the drugs chosen can be any FDA-approved drug. Therefore, it is not possible to pre-specify the medications.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Individualized therapy
2019
Completed Phase 4
~70
Find a Location
Who is running the clinical trial?
Jennifer ClarkeLead Sponsor
Jennifer Clarke, MDPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
166 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use birth control during and for 3 months after the study.I still have side effects from previous cancer treatments.I finished my first round of radiation less than 12 weeks ago.My cancer has spread to the lower part of my brain or its surrounding membranes.I have no active cancer except for GBM, or I've been cancer-free for 2 years, excluding certain skin cancers and localized cancers of the cervix, prostate, or breast.I am 18 years old or older.I am not pregnant.My kidney function is within the normal range.My heart functions well without significant limitations.I haven't had a heart attack or unstable chest pain in the last year.My glioblastoma or gliosarcoma has returned and can be surgically removed.My surgeon believes they can remove at least 500 mg of my tumor.I have received initial treatment for GBM, including radiation.My blood tests show enough white cells and platelets.My liver is functioning within the required limits.I am able to care for myself and perform normal activities with minimal assistance.I haven't had chemotherapy or radiotherapy in the last 4 weeks, except for specific treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Individualized therapy
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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