NCI 9979, Phase 1 and Pharmacology Study of Oral 5-iodo-2-pyrimidinone-2-deoxyribose (IPdR) as a Prodrug for IUdR-Mediated Tumor Radiosensitization in Brain Metastases
Categories (click each to see list of all clinical trials associated with that category): Brain/Neuro
Current Status: Open to accrual
Phase: I
Principal Investigator: Zhang, Chi
Contact Information:
Amy Filler-Katz, RN, BSN, CCRP
402-552-2790
afillerkatz@unmc.edu
Eligibility: https://clinicaltrials.gov/ct2/show/NCT02993146#eligibility
Summary
Primary Objective
To conduct a phase 1 dose escalation trial in patients with brain metastases to determine the recommended Phase II dose (RP2D) of daily oral IPdR administered alone for 7 days then concurrently with conventionally fractionated whole brain radiation therapy (WBRT) for 3 weeks.
Secondary Objectives
To evaluate radiographic overall response rates (ORR) using RECIST 1.1. Only patients in Part 2 of the study will be included in this evaluation.
To estimate 6-month intracranial progression-free survival (PFS).
To establish the pharmacokinetics of daily oral dosing of IPdR times 8 days.
To evaluate safety and tolerability of oral IPdR x 28 days and WBRT.
To estimate the incidence of delayed neurological toxicity at 2, 4, 6-months (± 1 week) post-completion of WBRT (for patients without intracranial progression) including:
a. Delayed-recall through HVLT-R
b. Quality of life as measured by the FACT-BR.