TRC102 and Temozolomide for Relapsed Solid Tumors and Lymphomas

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

93

Participants

Timeline

Start Date

July 12, 2013

Primary Completion Date

August 1, 2023

Study Completion Date

August 1, 2023

Conditions
LymphomasSolid TumorsNSCLCMetastatic Colon CarcinomaGranulosa Cell Ovarian Cancer
Interventions
DRUG

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.

DIAGNOSTIC_TEST

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).

OTHER

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.

OTHER

Prochlorperazine

If a participant develops nausea/vomiting, an anti-emetic such as prochlorperazine may be given.

OTHER

Metoclopramide

If a participant develops nausea/vomiting, an anti-emetic such as metoclopramide may be given.

OTHER

5-HT3 antagonist

If a participant develops nausea/vomiting, an anti-emetic such as 5-HT3 antagonist may be given.

OTHER

Aprepitant

If a participant develops nausea/vomiting, an anti-emetic such as aprepitant may be given.

PROCEDURE

Biopsy

Tumor biopsies will be optional during the escalation phase.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT01851369 - TRC102 and Temozolomide for Relapsed Solid Tumors and Lymphomas | Biotech Hunter | Biotech Hunter