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Feasibility of Individualized Therapy for Recurrent GBM

 

Summary

This phase I trial will evaluate an individualized treatment approach for patients with surgically resectable recurrent glioblastoma (GBM). 

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 identifies genetic changes in the DNA of a patient's cancer, which helps oncologists improve treatment by identifying targeted therapies. The treatment will be based on each patient’s individual tumor profile and will include up to four repurposed off-the-shelf FDA-approved medications.  

The objective of this phase I study is to assess the feasibility of implementing an individualized treatment regimen in patients with surgical recurrent GBM. All eligible participants will be provided an individualized treatment plan based on the results of their tumor analysis. 

 

Inclusion Criteria
  1. Patient age must be ≥ 18 years
  2. Patients must understand and provide written informed consent and HIPAA 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:
    1. Adequate bone marrow function:
      1.  absolute neutrophil count (ANC) ≥ 1,500/μL
      2. Platelets ≥ 100,000/μL
    2. 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
    3. Adequate renal function:
      1. 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. 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.
  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

For the most up-to-date list of criteria, please visit clinicaltrials.gov.

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 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.
     

For the most up-to-date list of criteria, please visit clinicaltrials.gov.

Investigator(s)

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