RecruitingPhase 2NCT04559230

Sacituzumab Govitecan in Recurrent Glioblastoma

A Phase II, Multicenter, Prospective Study of Sacituzumab Govitecan in Recurrent Glioblastoma


Sponsor

The University of Texas Health Science Center at San Antonio

Enrollment

32 participants

Start Date

Jan 6, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label single arm study. All patients will receive the study drug. The aim of the study is to compare overall survival (OS) of patients with recurrent brain tumor, known as Glioblastoma (GBM) having high levels of a protein, Trophoblast cell surface antigen 2 (Trop-2), expression on treatment with Sacituzumab Govitecan (SG) versus lomustine only which has been used in the past.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests sacituzumab govitecan — an antibody-drug that delivers chemotherapy directly to cancer cells — for patients with glioblastoma (GBM) whose brain tumor has come back after initial treatment. **You may be eligible if...** - You are 18 or older - You have been diagnosed with recurrent glioblastoma (a primary brain cancer) confirmed by biopsy - Your tumor is IDH wild-type (the most common and aggressive form) - You have already received standard radiation therapy and, if applicable, chemotherapy - If you had surgery for recurrence, it must be at least 2 weeks before starting this study **You may NOT be eligible if...** - Your tumor has an IDH mutation (a different subtype) - You have received more than one additional line of therapy after your initial treatment - You have had radiotherapy within the past 3 months - You are not stable enough to stop steroids or reduce them - You have significant other medical conditions affecting your safety Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSacituzumab Govitecan

Sacituzumab Govitecan will be administered by IV infusion over 3 hours for first administration and over 1 hour if tolerated. Subjects will be allowed to continue treatment until they have evidence of significant treatment-related toxicity or progressive disease.


Locations(3)

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Texas Oncology Austin

Austin, Texas, United States

University of Texas Health Science Center San Antonio at the Cancer Therapy and Research Center

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT04559230


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