Tailored tumor attack: can custom drug cocktails beat recurrent glioblastoma?
NCT ID NCT03681028
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study tested whether it's possible to quickly create and start a personalized drug combination for each patient with recurrent glioblastoma, a serious brain cancer. Researchers used genetic testing on tumor tissue to pick drugs that target specific mutations. The study enrolled 30 adults whose tumors could be surgically removed, and measured how many could start their custom treatment within 35 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- individualized combination of drugs based on genetic testing
- What this could lead to
- If successful, this approach could show that tailoring treatment to a patient's tumor genetics is feasible and may improve outcomes for recurrent glioblastoma.
- What could go wrong
- This is a very early, small pilot study (30 people) testing feasibility, not effectiveness. Many personalized regimens may not work or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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30 people
The number who actually took part.
- Started
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Dec 2018
- Finished
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Dec 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patient age must be \>= 18 years 2. 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 3. Patients must have recurrence of histologically-proven glioblastoma or gliosarcoma, World Health Organization (WHO) grade IV that is surgically resectable. 4. The patient's surgeon thinks that they can resect at least 500 mg of tumor. 5. Patient must have Karnofsky Performance Scale (KPS) score \>=70 6. Patient must have an estimated life expectancy ≥ 3 months 7. 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. 8. Patient must have adequate bone marrow function, renal function, and hepatic function as defined below: Adequate bone marrow function: 1. absolute neutrophil count (ANC) \>= 1,500/μL 2. Platelets \>= 100,000/μL Adequate hepatic function: 1. total bilirubin \<= 1.5x institutional upper limit of normal 2. Aspartate aminotransferase (AST) /serum glutamic-oxaloacetic transaminase (SGOT) \<= 2.5x institutional upper limit of normal 3. Alanine aminotransferase (ALT) / serum glutamic-pyruvic transaminase (SGPT) \<= 2.5x institutional upper limit of normal Adequate renal function: a. creatinine \<= 1.5x institutional upper limit of normal OR creatinine clearance \>= 60 mL/min/1.73 m2 9. Must be able to undergo MRI scans for tumor evaluation. 10. 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. 11. Patients must not have New York Heart Association (NYHA) Grade II or greater congestive heart failure 12. Patients must not have history of myocardial infarction or unstable angina within 12 months prior to study enrollment. Exclusion Criteria: 1. 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. 2. Patient who has not recovered to grade 1 or baseline from the adverse effects of prior radiotherapy or chemotherapy. 3. Patient who is \< 12 weeks from initial course of radiation 4. Patients with multifocal tumor, primarily infratentorial or posterior fossa tumor, or leptomeningeal dissemination of tumor. 5. 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 6. Patients known to be HIV-positive. HIV testing is not required for study participation. 7. 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. 8. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of California San Francisco
San Francisco, California, 94143, United States
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