Trials / Completed
CompletedNCT04757662
Tadalafil to Overcome Immunosuppression During Chemoradiotherapy for IDH-wildtype Grade III-IV Astrocytoma
A Phase IB Study to Use Tadalafil to Overcome Immunosuppression During Chemoradiotherapy for IDH-wildtype Grade III-IV Astrocytoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Washington University School of Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Increasing preclinical and clinical data have shown that myeloid-derived suppressor cells (MDSCs) may represent a significant driver of immunosuppression in glioblastoma (GBM, grade IV astrocytoma) and a potential mechanism of treatment resistance to chemoradiotherapy. Tadalafil, an FDA-approved drug with inexpensive cost and excellent safety profile, has been shown to effectively reduce MDSCs and restore T-cell activation in the peripheral blood and in the tumor microenvironment. The purpose of this study is to investigate the impact of targeting MDSCs in newly diagnosed IDH-wildtype grade III-IV astrocytoma by combining tadalafil with standard of care radiation therapy (RT) and temozolomide (TMZ).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tadalafil | Tadalafil is commercially available and will be purchased by the Siteman Cancer Center and distributed to participants free of charge. |
Timeline
- Start date
- 2021-05-14
- Primary completion
- 2023-06-07
- Completion
- 2023-06-07
- First posted
- 2021-02-17
- Last updated
- 2023-06-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04757662. Inclusion in this directory is not an endorsement.