93
Participants
Start Date
July 12, 2013
Primary Completion Date
August 1, 2023
Study Completion Date
August 1, 2023
TRC102
Methoxyamine hydrochloride (TRC102) has been shown to potentiate the activity of temozolomide by preventing base excision repair (BER) and allowing cleavage of TRC102 bound deoxyribonucleic acid (DNA), which will cause DNA strand breaks in cancer cells. We hypothesize that oral TRC102 can be safely co-administered with Temozolomide (TMZ) and would potentiate DNA damage caused by TMZ resulting in antitumor responses.
CT scan
CT scans will be performed at baseline, and repeat scans will be performed every 2 cycles (every 3 cycles for participants on study more than one year).
Lomotil
If diarrhea develops and does not have an identifiable cause other than study drug administration, anti-diarrheal's such as Lomotil (diphenoxylate hydrochloride (HCl) 2.5 mg + atropine sulfate 0.025 mg/tablet) dosed according to package insert or loperamide 4 mg by mouth (po) after the first unformed stool with 2 mg po every 2 hours as long as unformed stools continue (4 mg every 4 hours while asleep). No more than 16 mg of loperamide should be taken in during a 24-hour period.
Prochlorperazine
If a participant develops nausea/vomiting, an anti-emetic such as prochlorperazine may be given.
Metoclopramide
If a participant develops nausea/vomiting, an anti-emetic such as metoclopramide may be given.
5-HT3 antagonist
If a participant develops nausea/vomiting, an anti-emetic such as 5-HT3 antagonist may be given.
Aprepitant
If a participant develops nausea/vomiting, an anti-emetic such as aprepitant may be given.
Biopsy
Tumor biopsies will be optional during the escalation phase.
National Institutes of Health Clinical Center, Bethesda
National Cancer Institute (NCI)
NIH