This an an open-label study to define the safety profile and the maximum tolerated dose and confirm the clinical effective dose of palifosfamide-tris given intravenously in combination with etoposide and carboplatin in a wide range of cancers which etoposide and carboplatin are normally given. Once the maximum dose of palifosfamide-tris is determined,a Phase II study using the 3 agents combined will begin.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Intravenous on days 1, 2 and 3 of each 21-day cycle for up to 4 cycles
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States
Horizon Oncology Research
Lafayette, Indiana, United States
Medical Consultants, PC
Muncie, Indiana, United States
Washington University
St Louis, Missouri, United States
Assess the safety profile
Adverse events, vital signs, physical examination, laboratory data and concomitant medications
Time frame: 21 Days
Determine the maximum tolerated dose
Each dose level cohort will be 3 subjects. After 3 subjects have received a regimen, there will be a minimum observation period of 1 full cycle (21 days) for each of the 3 subjects before enrollment of the group of subjects at the next dose level.
Time frame: Up to 21 days
Assess early signs of efficacy
To assess early signs of efficacy using this investigational combination in this patient population
Time frame: duration of study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.