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Neuro/Sacituzumab Govitecan/Breast Brain Metastasis/Glioblastoma/Ph 0 | Clinical Trials | Clareo Health

COMPLETEDEARLY_PHASE1

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

A Phase 0, Investigator Initiated Study to Determine the Bioavailability of Sacituzumab Govitecan in Breast Brain Metastasis and Glioblastoma

NCT03995706•The University of Texas Health Science Center at San Antonio

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Exclusion Criteria

•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
+19 more criteria

Locations (1)

Mays Cancer Center, UT Health San Antonio

San Antonio, Texas, United States

Key Dates

Start Date

July 17, 2019

Primary Completion Date

June 3, 2022

Completion Date

March 20, 2024

Last Updated

September 4, 2024

Enrollment

ACTUAL participants

Conditions

Glioblastoma

Interventions

Sacituzumab Govitecan

DRUG

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

View study

RECRUITINGPHASE1

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

NCT06860594

Astrocytoma, IDH-Mutant, Grade 2Recurrent Adult Diffuse Hemispheric Glioma, H3 G34-Mutant+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 4, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Targeted Pediatric High-Grade Glioma Therapy

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma

EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma

Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma