A Phase 1 Trial to Evaluate the Safety and Tolerability of Fb-PMT in Patients With Recurrent Glioblastoma
NanoPharmaceuticals LLC
Summary
Glioblastoma is a highly aggressive and fatal form of primary malignant brain tumor with limited treatment options. fb-PMT affects a large group of cancer cell signaling pathways and thus may be effective in heterogeneous, treatment-resistant tumors such as Glioblastoma. fb-PMT also is actively transported across the blood-brain barrier into the brain. This study is being conducted to determine the dose level for further clinical development of fb-PMT to treat recurrent Glioblastoma.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically proven intracranial glioblastoma, with first or second recurrence * On stable or decreasing dose of steroids, if taken prior to screening * Baseline MRI (with and without contrast) completed with 5 days of starting fb-PMT * Prior completion of and recovery from the effects of standard of care for glioblastoma management with surgery/biopsy and radiotherapy * Confirmation of true progressive disease for patients previously treated with interstitial brachytherapy or stereotactic radio surgery * Life expectancy of more than three months * Karnofsky Performanc…
Interventions
- Drugfb-PMT
Daily dosing based on patient weight
Location
- Smilow Cancer HospitalNew Haven, Connecticut