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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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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 more

Trial 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

0 / 10Eligibility criteria met

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

Individualized therapy (Targeted Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03681028 — Phase 1

Glioblastoma Research Study Groups: Individualized therapy

Glioblastoma Clinical Trial 2023: Individualized therapy Highlights & Side Effects. Trial Name: NCT03681028 — Phase 1

Individualized therapy (Targeted Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03681028 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the desired outcomes of this research?

"The primary efficacy measure for this trial, which will be monitored over a window of up to 35 days after surgery, is Overall Survival at 9 months (OS). Secondary outcomes comprise Progression-Free Survival (PFS) 6 months post treatment commencement determined by RANO criteria and Kaplan Meier method; OS calculated via the Kaplan-Meier technique until date of death or last known survival status; as well as incidence rate of grade 3-5 Adverse Events (AEs), according to NCI Common Terminology Criteria for AEs v. 5.0 caused either by individual or combined treatments."

Answered by AI

How many enrollees are currently participating in this research experiment?

"Correct. The information available on clinicaltrials.gov affirms that this medical research is seeking recruits right now. It was initially posted on December 19th 2018 and last updated November 4th 2022, with a requirement of 30 participants from one site."

Answered by AI

Does the FDA approve of this therapeutic procedure?

"Due to the limited clinical data available, our team at Power cautiously assigned a score of 1 for the treatment's safety in this Phase 1 trial."

Answered by AI

Is recruitment for this experiment ongoing?

"This clinical trial is currently recruiting patients, according to the information on clinicaltrials.gov. The medical study was first published on December 19th 2018 and underwent its last edit November 4th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility of Individualized Therapy for Recurrent Glioblastoma

Jennifer Clarke 2018. "Feasibility of Individualized Therapy for Recurrent Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03681028.