Feasibility of Individualized Therapy for Recurrent GBM
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03681028|
Recruitment Status : Recruiting
First Posted : September 21, 2018
Last Update Posted : November 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Glioblastoma||Drug: Individualized therapy||Phase 1|
This is a single arm, non-randomized open-label study to assess feasibility of implementing an individualized treatment regimen in patients with surgical recurrent GBM. Patients are not stratified according to demographic or treatment-related parameters. Patients must have recurrent glioblastoma treated with appropriate tumor treatment including radiation therapy at initial diagnosis. Surgery must be clinically indicated and patients must be candidates for tumor resection at UCSF.
The goal of the current study is to build upon prior results by confirming the feasibility of actually implementing patient-specific drug regimens in a rapid, clinically-relevant timetable. The investigators will also assess for efficacy, safety, and response outcomes of these patient-specific regimens, to generate preliminary data that would support a larger trial assessing efficacy of such an approach.
Resected tumor tissue and blood will be examined using Next Generation Sequencing (NGS) UCSF 500 Cancer Gene Panel at the UCSF Clinical Cancer Genomics Laboratory and Whole genome and RNA sequencing. The clinical report generated from the NGS UCSF 500 panel will be provided to a study-specific Tumor Board who will generate an individualized treatment recommendation based on the report. The individualized treatment regimen potentially will include up to 4 re-purposed, off-the-shelf, FDA-approved targeted agents. The Board will identify the expected/anticipated drug-drug interactions and anticipated additional toxicities of the combination of therapies. The treating physician is given the report, discusses the suggested treatment options with the patient, and initiates treatment, ideally within 28 calendar days (and no later than 35 calendar days) after surgery.
Patients may continue treatment until tumor progression, intolerable side effects, or patient/physician choice to discontinue.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study Testing Feasibility of Individualized Therapy for Recurrent Glioblastoma|
|Actual Study Start Date :||December 19, 2018|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||January 31, 2027|
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.
Drug: Individualized therapy
- Percentage of patients who have successfully initiated therapy [ Time Frame: Up to 35 days after surgery ]Feasibility of implementing a truly personalized tumor treatment drug regimen for patients with surgically resectable recurrent glioblastoma is defined as the percentage of patients who have successfully initiated therapy based on their individualized treatment regimen within 35 days following surgical resection of recurrent tumor.
- Overall survival at 9 months (OS) [ Time Frame: Up to 9 months ]Overall survival is defined as the length of time from start of individual treatment or combination treatment regimen until 270 days, or 9 months. For the participants who were alive at the end of study or lost to follow-up, overall survival will be censored on the last date when participants were known to be alive. OS will be estimated using the Kaplan-Meier method.
- Incidence of treatment-related Adverse Events (AEs) [ Time Frame: Up to 1 year ]Incidence of treatment-related AEs, grades 3-5 using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 either due to individual treatment or combination treatment regimen
- Progression-Free Survival (PFS) at 6 months [ Time Frame: 6 months ]PFS at 6 months is defined as the percentage of participants who have neither progressed nor died within 6 months after the first dose of individual treatment or combination treatment regimen. PFS at 6 months will be assessed by (modified) Response assessment in neuro-oncology criteria (RANO) and estimated using Kaplan Meier method.
- Progression-Free Survival (PFS) [ Time Frame: Up to 5 years. ]PFS period is defined as the number of days from start of individual treatment or combination treatment regimen to disease progression or death. The PFS days of patient groups will be estimated using Kaplan-Meier method to show median progression-free period (days when 50% patients remain progression-free).
- Time to Treatment Failure (TTF) [ Time Frame: Up to 5 years ]Time to treatment failure is defined as the time from start of treatment to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death.
- Overall survival (OS) [ Time Frame: Up to 5 years ]Overall survival is defined as the length of time from start of individual treatment or combination treatment regimen until date of death. For the participants who were alive at the end of study or lost to follow-up, overall survival will be censored on the last date when participants were known to be alive. OS will be estimated using the Kaplan-Meier method.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03681028
|Contact: Jane Rabbitt, RN||415-353-2382||Jane.Rabbitt@ucsf.edu|
|United States, California|
|University of California San Francisco||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Jane Rabbitt, RN 415-353-2652 Jane.Rabbitt@ucsf.edu|
|Contact: Meghan Tedesco 415-353-1866 Meghan.Tedesco@ucsf.edu|
|Principal Investigator: Jennifer Clarke, MD, MPH|
|Principal Investigator:||Jennifer Clarke, MD||University of California, San Francisco|