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Neuro/Sacituzumab Govitecan/Breast Brain Metastasis/Glioblastoma/Ph 0

Study Purpose

Single center, non-randomized, Phase 0 study. Sacituzumab Govitecan given preoperatively, followed by craniotomy with surgery or biopsy of brain tumors (GBM and metastatic brain tumors from Breast) and intraoperative tissue collection will follow with contemporaneous CSF (depending on tumor location) and whole blood (serum) sampling.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - At least 18 years of age.
  • - Histologically or cytologically documented breast cancer (Cohort A) with known or suspected parenchymal brain metastases.
  • - Recurrent glioblastoma (Cohort B) with documented progression by RANO criteria following standard combined modality treatment with radiation and temozolomide.
  • - Plans to undergo craniotomy as part of standard of care.
Patients emergently needing surgical debulking due to symptoms of their disease are not eligible.
  • - Recovered from toxicities of prior therapy to grade 0 or 1.
  • - ECOG performance status ≤ 2.
  • - Life expectancy of at least 3 months.
  • - Acceptable liver function: - Bilirubin ≤ 1.5 times upper limit of normal.
  • - AST (SGOT) and ALT (SGPT) ≤ 3.0 times upper limit of normal (ULN); - Adequate renal function: calculated creatinine clearance ≥30mL/minute according to the Cockcroft and Gault formula.
  • - Acceptable hematologic status (without hematologic support) - ANC ≥1500 cells/uL.
  • - Platelet count ≥100,000/uL.
  • - Hemoglobin ≥9.0 g/dL.
  • - All women of childbearing potential must have a negative serum pregnancy test and male and female subjects must agree to use effective means of contraception (surgical sterilization or the use or barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 6 months after the last dose.

Exclusion Criteria:

  • - The subject is receiving warfarin (or other coumarin derivatives) and is unable to switch to low molecular weight heparin (LMWH) before the first dose of study drug.
  • - The subject has evidence of acute intracranial or intratumoral hemorrhage either by MRI or computerized tomography (CT) scan.
Subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin are eligible.
  • - The subject is unable to undergo MRI scan (eg, has pacemaker).
  • - The subject has received enzyme-inducing anti-epileptic agents within 14 days of study drug (eg, carbamazepine, phenytoin, phenobarbital, primidone).
  • - Patients whose only lesion undergoing resection has received stereotactic radiation within the past 3 months.
  • - The subject has received any of the following prior anticancer therapy: - Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to first dose of study drug.
  • - Prior treatment with Sacituzumab Govitecan.
  • - Patients receiving UGT1A1 (Uridine diphosphate glucuronosyl transferase 1A1) inhibitors or inducers.
  • - History of significant cardiovascular disease, defined as: - Congestive heart failure greater than New York Heart Association (NYHA) Class II according to the NYHA Functional Classification.
  • - Unstable angina or myocardial infarction within 6 months before enrollment.
  • - Serious cardiac arrhythmia.
  • - Clinically significant ECG abnormality, including: - Marked Baseline prolonged QT/QTc interval (ie, a repeated demonstration of a QTc interval >500 ms) demonstrated on ECG at Screening.
  • - History of risk factors for torsade de pointes (eg, heart failure, hypokalemia, family history of long QT Syndrome).
  • - Any medical or other condition which, in the opinion of the Investigator, causes the subject to be medically unfit to receive Sacituzumab Govitecan, or unsuitable for any other reason.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03995706
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 The University of Texas Health Science Center at San Antonio
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Andrew Brenner, MD, PhD
Principal Investigator Affiliation University of Texas Health at San Antonio
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Breast Brain Metastasis and Glioblastoma

Sacituzumab Govitecan treatment will be initiated with a 10mg/kg standard dose without any dose escalation on day-1, prior to surgery. Sacituzumab govitecan and will continue to be administered by IV infusion over 3 hours on Days 1 and 8 of a 21 day cycle post-operatively until progression.

Interventions

Drug: - Sacituzumab Govitecan

All 20 subjects will receive study drug Sacituzumab Govitecan preoperatively. Intraoperative tissue collection will follow with contemporaneous CSF (depending on tumor location) and whole blood (serum) sampling. Samples will be tested for total SN-38and free SN-38, as well as SN-38G. Following recovery from surgery, patients will resume treatment

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

San Antonio, Texas

Status

Address

Mays Cancer Center, UT Health San Antonio

San Antonio, Texas, 78229

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