Individualized Therapy for Glioblastoma

Overseen By Stephanie Lewis, RN

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Jennifer Clarke

Must not be taking: Chemotherapy, Radiotherapy

Disqualifiers: Multifocal tumor, Active malignancy, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Up to 9 months

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot have had chemotherapy or radiotherapy within 4 weeks before joining the study, with specific time requirements for certain drugs like temozolomide and nitrosurea.

What data supports the effectiveness of the treatment Individualized therapy for Glioblastoma?

Research suggests that personalized treatment approaches, which tailor therapies based on a patient's specific genetic and molecular tumor characteristics, could significantly improve survival rates for glioblastoma patients. This approach is promising because it targets the unique features of each patient's tumor, potentially leading to better outcomes compared to standard treatments. ^{1 2 3 4 5}

Is individualized therapy for glioblastoma safe for humans?

Immunotherapy, which is part of individualized therapy, has shown an acceptable safety and tolerability profile in patients with recurrent glioblastoma, according to clinical trials. ^{6 7 8 9 10}

How does individualized therapy for glioblastoma differ from other treatments?

Individualized therapy for glioblastoma is unique because it tailors treatment plans based on the specific genetic and molecular characteristics of a patient's tumor, unlike standard treatments that apply the same approach to all patients. This personalized approach aims to improve outcomes by targeting the unique features of each tumor, potentially leading to better survival rates. ^{1 2 11 12 13}

What is the purpose of this trial?

The current study will test the ability and likelihood of successfully implementing individualized combination treatment recommendations for adult patients with surgically-resectable recurrent glioblastoma in a timely fashion. Collected tumor tissue and blood will be examined using a new diagnostic testing called University of California, San Francisco (UCSF) 500 Cancer Gene Panel which is done at the UCSF Clinical Cancer Genomics Laboratory. The UCSF 500 Cancer Gene Panel will help identify genetic changes in the DNA of a patient's cancer, which helps oncologists improve treatment by identifying targeted therapies.

Research Team

Jennifer Clarke, MD, MPH

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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.

Inclusion Criteria

Patient must have an estimated life expectancy ≥ 3 months

I agree to use birth control during and for 3 months after the study.

Patients must understand and provide written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization prior to initiation of any study-specific procedures

Exclusion Criteria

Patients known to be HIV-positive

Uncontrolled concurrent illness including psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent

Any other acute or chronic medical or psychiatric condition, or laboratory abnormality that could increase the risk associated with trial participation or trial drug administration or could interfere with the interpretation of trial results, and, in the judgment of the investigator, would make the patient inappropriate for entry into the trial

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Diagnostic Testing

Surgery for tumor resection followed by diagnostic testing using UCSF 500 Cancer Gene Panel

Up to 5 weeks

1 visit (in-person) for surgery, additional visits for testing

Treatment

Initiation of individualized treatment regimen based on Tumor Board recommendations

Up to 9 months

Regular visits as per treatment protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Treatment Details

Interventions

• Individualized therapy

Trial Overview 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.

Participant Groups

Group I: Individualized therapy Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Jennifer Clarke

Lead Sponsor

Trials

1

Recruited

30+

Findings from Research

Despite aggressive treatment options for glioblastoma, including surgery and chemotherapy, the median survival remains low at 14-16 months, highlighting the need for new therapeutic strategies.

Recent data suggest that the Optune™ device, which delivers alternating electrical field therapy, may improve survival in newly diagnosed glioblastoma patients, indicating a promising new approach alongside traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What next for newly diagnosed glioblastoma? Domingo-Musibay, E., Galanis, E.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

One size should not fit all: advancing toward personalized glioblastoma therapy. [2015]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Personalized Treatment of Glioblastoma: Current State and Future Perspective. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Treating recurrent glioblastoma: an update. [2022]

4. Bulgaria pubmed.ncbi.nlm.nih.gov

"Security dilemma": active immunotherapy before versus after radiation therapy alone or chemo-radiotherapy for newly diagnosed glioblastoma. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Personalised therapeutic approaches to glioblastoma: A systematic review. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Individualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT): A Bayesian Adaptive Platform Trial to Develop Precision Medicines for Patients With Glioblastoma. [2023]

7. Ireland pubmed.ncbi.nlm.nih.gov

Study protocol: PreOperative Brain Irradiation in Glioblastoma (POBIG) - A phase I trial. [2023]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of Glioblastoma: Established Treatments and Emerging Concepts. [2020]

9. England pubmed.ncbi.nlm.nih.gov

What next for newly diagnosed glioblastoma? [2022]

10. Italy pubmed.ncbi.nlm.nih.gov

Tailored therapy for recurrent glioblastoma: report of a personalized molecular approach. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Individualized targeted therapy for glioblastoma: fact or fiction? [2015]

12. England pubmed.ncbi.nlm.nih.gov

Novel chemotherapeutic agents for the treatment of glioblastoma multiforme. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

The challenges associated with molecular targeted therapies for glioblastoma. [2018]