NCT02187822

Fractionated Stereotactic Radiotherapy (FSRT) in Treatment of Brain Metastases

A Phase 1 Study of TPI 287 Concurrent With Fractionated Stereotactic Radiotherapy (FSRT) in Treatment of Brain Metastases From Advanced Breast and Non-Small Cell Lung (NSCL) Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to see whether addition of TPI 287 to FSRT is safe and tolerable. Researchers also want to find out if adding TPI 287 to FSRT can help with better controlling the growth of brain lesions in people with brain metastases from their cancer.

Detailed description

Standard of care for treatment of patients with brain metastases, which are considered not surgically removable, is radiation therapy to the brain lesions. This treatment is called Fractionated Stereotactic Radiotherapy (FSRT) and is given without chemotherapy and usually over 5 days. Researchers of this study want to find out if adding an investigational drug, called TPI 287, to standard radiation therapy (FSRT) can help people with brain metastases from cancer. TPI 287 is a drug that is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA).

Conditions

• Brain Metastases
• Generalized Malignancy, Primary
• Brain Lesions

Interventions

Type	Name	Description
DRUG	TPI 287	TPI 287 is an infusion given through veins. Dose escalation will begin at 14 mg/m\^2/dose. Dose expansion will begin at the maximum tolerated dose (MTD).
PROCEDURE	Fractionated Stereotactic Radiotherapy (FSRT)	The prescription dose will be 25 gray (Gy) in 5 daily fractions delivered to the planning target volume (PTV).

Timeline

• Start date: 2014-10-09
• Primary completion: 2018-02-20
• Completion: 2018-03-31
• First posted: 2014-07-11
• Last updated: 2021-02-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study