A Phase II, Multicenter, Prospective Study of Sacituzumab Govitecan in Recurrent Glioblastoma
The University of Texas Health Science Center at San Antonio
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.
Description
Subjects are expected to participate for up to treatment duration with continued follow up for survival until one year after the last dose of study drug. The total duration of the active part of the study for each subject will be approximately 18 weeks, divided as follows: * Up to 3 weeks predose (screening period) * 3-week treatment periods of Sacituzumab govitecan * Study termination visit 3-4 weeks after last dose of study medication When a subject has completed the study termination or early termination visit, he/she and/or a family member will be contacted for survival information every…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. At least 18 years of age. 2. Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee. 3. Histologically confirmed IDH wild type (primary) GBM. Molecular GBM (as per cIMPACT-NOW 3) is allowed as is gliosarcoma and epithelioid glioblastoma. IDH-mutant glioma is not allowed. 4. Progression following standard combined modality treatment with radiation and temozolomide chemotherapy if O6-Methylguanine-DNA Methyltransferase (MGMT) methylated. * Prior temozolomide is not re…
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 CenterCleveland, Ohio
- Texas Oncology AustinAustin, Texas
- University of Texas Health Science Center San Antonio at the Cancer Therapy and Research CenterSan Antonio, Texas