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

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ClinicalTrials.gov Identifier: NCT03995706
Recruitment Status : Recruiting
First Posted : June 24, 2019
Last Update Posted : August 1, 2019
Sponsor:
Collaborator:
Immunomedics, Inc.
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: Sacituzumab Govitecan Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 0, Investigator Initiated Study to Determine the Bioavailability of Sacituzumab Govitecan in Breast Brain Metastasis and Glioblastoma
Actual Study Start Date : July 17, 2019
Estimated Primary Completion Date : July 10, 2021
Estimated Study Completion Date : July 10, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. Ratio of SN-38 and its metabolites relative to serum concentration [ Time Frame: Day 1 of each 21 day cycle ]
    Levels of SN-38 and its metabolites will be measured and a ratio calculated relative to the serum concentration of SN-38 and its metabolites. The ratio will show the amount of investigational product that crosses the blood brain barrier to reach the tumor.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995706


Contacts
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Contact: Epp Goodwin 210-450-5798 ctrcreferral@uthscsa.edu

Locations
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United States, Texas
Mays Cancer Center, UT Health San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Epp Goodwin    210-450-1000      
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Immunomedics, Inc.

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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT03995706     History of Changes
Other Study ID Numbers: CTMS# 19-0069
HSC20190378H ( Other Identifier: UT Health Science Center Institutional Review Board )
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioblastoma
Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Camptothecin
Immunoconjugates
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs