Recurrent GlioblastomaPhase 1NCT03681028
Feasibility of Individualized Therapy for Recurrent Glioblastoma
A Phase 1 study testing Individualized therapy in people with Recurrent Glioblastoma, run by Jennifer Clarke at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Glioblastoma
- What is being tested?
- Individualized therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2018to 31 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age must be >= 18 years
- Patients must understand and provide written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization authorization prior to initiation of any study-specific procedures
- Patients must have recurrence of histologically-proven glioblastoma or gliosarcoma, World Health Organization (WHO) grade IV that is surgically resectable.
- The patient's surgeon thinks that they can resect at least 500 mg of tumor.
- Patient must have Karnofsky Performance Scale (KPS) score >=70
- Patient must have an estimated life expectancy ≥ 3 months
Show all 22Show fewer
- Patients may enroll independent of number of prior therapies or cumulative doses of prior therapies, but must have received appropriate prior therapy for GBM at time of initial diagnosis, including radiation therapy.
- Patient must have adequate bone marrow function, renal function, and hepatic function as defined below:
- Adequate bone marrow function:
- absolute neutrophil count (ANC) >= 1,500/μL
- Platelets >= 100,000/μL
- Adequate hepatic function:
- total bilirubin <= 1.5x institutional upper limit of normal
- Aspartate aminotransferase (AST) /serum glutamic-oxaloacetic transaminase (SGOT) <= 2.5x institutional upper limit of normal
- Alanine aminotransferase (ALT) / serum glutamic-pyruvic transaminase (SGPT) <= 2.5x institutional upper limit of normal
- Adequate renal function:
- creatinine <= 1.5x institutional upper limit of normal OR creatinine clearance >= 60 mL/min/1.73 m2
- Must be able to undergo MRI scans for tumor evaluation.
- Women of child-bearing potential must have a negative pregnancy test (urine or serum) within 7 days prior to surgery.
- The effects of study drugs, either individually or their combination on the developing human fetus are unknown. For this reason, 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. The use of adequate contraception may be longer than 3 months depending on the drugs used and the FDA-approved labeling in cases of recommendation for contraception. Adequate contraception may include hormonal contraception, barrier method (condom, contraceptive sponge, diaphragm or ring), intrauterine device (IUD), tubal ligation, vasectomy and abstinence. Should a woman become pregnant (or suspect that she is pregnant) while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of study drug administration. Patient must not be a woman who is currently pregnant, due to the potential for teratogenic or abortifacient effects of study drugs, either alone or in combination. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with study drugs, lactating women who are breastfeeding should discontinue breastfeeding if the mother is treated with any study drug.
- Patients must not have New York Heart Association (NYHA) Grade II or greater congestive heart failure
- Patients must not have history of myocardial infarction or unstable angina within 12 months prior to study enrollment.
Who cannot join
- Patient who has been treated with any chemotherapy or radiotherapy ≤4 weeks prior to date of study registration. Exceptions to this include: must be ≥ 23 days from last dose of temozolomide (TMZ), must be ≥ 6 weeks from last dose of nitrosurea.
- Patient who has not recovered to grade 1 or baseline from the adverse effects of prior radiotherapy or chemotherapy.
- Patient who is < 12 weeks from initial course of radiation
- Patients with multifocal tumor, primarily infratentorial or posterior fossa tumor, or leptomeningeal dissemination of tumor.
- Patient with any other active malignancy besides GBM, excluding non-melanomatous skin cancer, or carcinoma in situ of the cervix, prostate, or breast, unless patient has been disease-free/in remission for >=2 years prior to date of study enrollment
- Patients known to be HIV-positive. HIV testing is not required for study participation.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Pilot Study Testing Feasibility of Individualized Therapy for Recurrent Glioblastoma
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.
Read the detailed description
This is a single arm, non-randomized open-label study to assess feasibility of implementing an individualized treatment regimen in patients with surgical recurrent glioblastoma (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.
- Conditions
- Recurrent Glioblastoma
- Being tested
- Individualized therapy
- Keywords
- Glioblastoma, Adult Glioblastoma, Glioma, Precision Medicine, Specialized Tumor Board
- Medical subject headings
- Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized therapyDrug
- For a given proposed individualized combination of drugs the first priority to establish doses will be to identify the same combination of drugs in a peer-reviewed journal article or presented as a reviewed abstract.
- When a proposed individualized combination of drugs has not previously been reported, the process to establish doses will be to then identify individual members of the proposed combination that have been used in combination with other cytotoxic agents similar to those being considered for combination therapy.
- When a proposed individualized combination of drugs has no available combination data, dosing guidelines will start with the FDA-approved package insert recommended dose.
| Study group | Role | What they receive |
|---|---|---|
| Individualized therapy | Other | 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. Receives: Drug: Individualized therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who have successfully initiated therapy
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.
Measured: Up to 35 days after surgery
Overall survival at 9 months (OS)
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.
Measured: Up to 9 months
Secondary outcomes (5)
Incidence of treatment-related Adverse Events (AEs)
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
Measured: Up to 1 year
Progression-Free Survival (PFS) at 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.
Measured: 6 months
Progression-Free Survival (PFS)
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).
Measured: Up to 5 years.
Time to Treatment Failure (TTF)
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.
Measured: Up to 5 years
Overall survival (OS)
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.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start19 Dec 2018
- Primary completion30 Nov 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Clarke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jennifer Clarke, University of California, San Francisco
- Investigators
- Jennifer Clarke, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681028
- Sponsor's protocol ID
- 18108
- Other IDs
- NCI-2018-02194
- Status last verified
- Feb 2026
- First submitted
- 17 Sep 2018
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data may be shared with study collaborators during the course of the study.
Publications
Chen J, Oberheim Bush NA, Grabowsky JA, Kline C, Kroetz DL, Taylor JW, Villanueva-Meyer J, Molinaro AM, de Groot JF, Butowski NA, Tedesco M, Rabbitt J, Phillips JJ, Hervey-Jumper S, Aghi MK, Berger MS, Chang EF, Chang SM, Solomon DA, Clarke JL. A Genomically Tailored Multiagent Precision Medicine Clinical Trial for Adults with Recurrent Glioblastoma. Clin Cancer Res. 2026 May 1;32(9):1652-1665. doi: 10.1158/1078-0432.CCR-25-4080.
PubMed 41649856
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Testing Feasibility of Individualized Therapy for Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT03681028
- Acronym / sponsor ID
- 18108
- Conditions
- Recurrent Glioblastoma
- Keywords
- Glioblastoma, Adult Glioblastoma, Glioma, Precision Medicine, Specialized Tumor Board
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jennifer ClarkeUniversity, hospital or other
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 21 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single arm, non-randomized open-label study to assess feasibility of implementing an individualized treatment regimen in patients with surgical recurrent glioblastoma (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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individualized therapy | Other | Drug: Individualized therapyStudy 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Patient age must be >= 18 years
- Patients must understand and provide written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization authorization prior to initiation of any study-specific procedures
- Patients must have recurrence of histologically-proven glioblastoma or gliosarcoma, World Health Organization (WHO) grade IV that is surgically resectable.
- The patient's surgeon thinks that they can resect at least 500 mg of tumor.
- Patient must have Karnofsky Performance Scale (KPS) score >=70
Key exclusion criteria (8 listed)
- Patient who has been treated with any chemotherapy or radiotherapy ≤4 weeks prior to date of study registration. Exceptions to this include: must be ≥ 23 days from last dose of temozolomide (TMZ), must be ≥ 6 weeks from last dose of nitrosurea.
- Patient who has not recovered to grade 1 or baseline from the adverse effects of prior radiotherapy or chemotherapy.
- Patient who is < 12 weeks from initial course of radiation
- Patients with multifocal tumor, primarily infratentorial or posterior fossa tumor, or leptomeningeal dissemination of tumor.
- Patient with any other active malignancy besides GBM, excluding non-melanomatous skin cancer, or carcinoma in situ of the cervix, prostate, or breast, unless patient has been disease-free/in remission for >=2 years prior to date of study enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized therapy1. For a given proposed individualized combination of drugs the first priority to establish doses will be to identify the same combination of drugs in a peer-reviewed journal article or presented as a reviewed abstract. 2. When a proposed individualized combination of drugs has not previously been reported, the process to establish doses will be to then identify individual members of the proposed combination that have been used in combination with other cytotoxic agents similar to those being considered for combination therapy. 3. When a proposed individualized combination of drugs has no available combination data, dosing guidelines will start with the FDA-approved package insert recommended dose. | Drug | Individualized therapy |
Primary outcome
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.
5 secondary outcomes
Incidence of treatment-related Adverse Events (AEs)
Time frame: Up to 1 year
Progression-Free Survival (PFS) at 6 months
Time frame: 6 months
Progression-Free Survival (PFS)
Time frame: Up to 5 years.
Time to Treatment Failure (TTF)
Time frame: Up to 5 years
Overall survival (OS)
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Background: PubMed 41649856Chen J, Oberheim Bush NA, Grabowsky JA, Kline C, Kroetz DL, Taylor JW, Villanueva-Meyer J, Molinaro AM, de Groot JF, Butowski NA, Tedesco M, Rabbitt J, Phillips JJ, Hervey-Jumper S, Aghi MK, Berger MS, Chang EF, Chang SM, Solomon DA, Clarke JL. A Genomically Tailored Multiagent Precision Medicine Clinical Trial for Adults with Recurrent Glioblastoma. Clin Cancer Res. 2026 May 1;32(9):1652-1665. doi: 10.1158/1078-0432.CCR-25-4080.
- Individual participant dataSharing planned: Yes. De-identified data may be shared with study collaborators during the course of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Clarke, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Individualized therapy in people with Recurrent Glioblastoma, run by Jennifer Clarke at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who have successfully initiated therapy (time frame: Up to 35 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03681028, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.