Fractionated Stereotactic Radiotherapy (FSRT) in Treatment of Brain Metastases (NCT02187822) | Clinical Trial Compass
TerminatedPhase 1
Fractionated Stereotactic Radiotherapy (FSRT) in Treatment of Brain Metastases
Stopped: lack of funding by company providing TPI-287
United States15 participantsStarted 2014-10-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Must have histologically or cytologically confirmed non-central nervous system primary solid malignancy.
* Must have pathologically or radiologically confirmed metastatic disease in the brain.
* Potential participants with up to 3 brain metastases (symptomatic and non-symptomatic) can be treated on this study. Maximum diameter of each brain lesion should be ≤ 5 cm. Maximum tumor volume ≤ 120 cc.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%).
* Life expectancy of greater than 12 weeks.
* Patients requiring treatment with corticosteroids are eligible.
* Treatment with non-enzyme inducing anti-seizure medications is allowed.
* Must have normal organ and marrow function.
* Systemic chemotherapy washout period ≥ 7 days. For investigational dugs and monoclonal antibodies washout period ≥ 5x drug half-life. There are no limitations on number of prior treatment regimens.
* Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of TPI 287 administration.
* Prior brain surgery or radiation is al…
What they're measuring
1
Maximum Tolerated Dose (MTD) of TPI 287
Timeframe: Up to 2 years
Trial details
NCT IDNCT02187822
SponsorH. Lee Moffitt Cancer Center and Research Institute