Summary

for people ages 18 years and up (full criteria)
at San Francisco, California
study started
estimated completion:
Jennifer Clarke

Description

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. Collected tumor tissue and blood will be examined using a new diagnostic testing called 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.

Official Title

Pilot Study Testing Feasibility of Individualized Therapy for Recurrent Glioblastoma

Details

This is a pilot, single-institution, single cohort, 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. We 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 repurposed 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. Treatment will continue until tumor progression.

Keywords

Recurrent Glioblastoma Glioblastoma Adult Glioblastoma Glioma Precision Medicine Specialized Tumor Board Individualized therapy

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Patient age must be ≥ 18 years
  2. Patients must understand and provide written informed consent and HIPAA authorization authorization prior to initiation of any study-specific procedures
  3. Patients must have recurrence of histologically-proven glioblastoma or gliosarcoma,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 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. AST(SGOT) ≤ 2.5x institutional upper limit of normal
  3. ALT(SGPT) ≤ 2.5x institutional upper limit of normal

Adequate renal function:

  1. creatinine ≤ 1.5x institutional upper limit of normal OR creatinine clearance ≥ 60 mL/min/1.73 m2
  2. Must be able to undergo MRI scans for tumor evaluation.
  3. . 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.
  4. . Patients must not have New York Heart Association (NYHA) Grade II or greater congestive heart failure
  5. . Patients must not have history of myocardial infarction or unstable angina within 12 months prior to study enrollment.

You CAN'T join if...

  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 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 alignancy 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.

Location

  • University of California San Francisco accepting new patients
    San Francisco California 94143 United States

Lead Scientist

  • Jennifer Clarke
    Associate Professor, Neurology. Authored (or co-authored) 34 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Jennifer Clarke
ID
NCT03681028
Phase
Phase 1
Study Type
Interventional
Last Updated