TRC102 and Temozolomide for Relapsed Solid Tumors and Lymphomas

Summary

Background:

\- Methoxyamine hydrochloride (TRC102) is a new cancer treatment drug that may help improve the results of chemotherapy. It blocks tumor cells' attempts to repair damaged deoxyribonucleic acid (DNA), which may allow chemotherapy to kill the cells more easily. Researchers want to see how well it works with temozolomide, a chemotherapy drug that is designed to damage tumor cell DNA. These drugs will be given to people who have advanced solid tumors or lymphomas that have not responded to earlier treatments.

Objectives:

\- To test the safety and effectiveness of TRC102 and temozolomide for advanced solid tumors and lymphomas.

Eligibility:

\- Individuals at least 18 years of age who have advanced solid tumors or lymphomas that have not responded to earlier treatments.

Design:

* Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Tumor samples may also be collected. The size and location of the tumors will be determined with imaging studies.
* Participants will take TRC102 and temozolomide for 28-day cycles of treatment. They will take temozolomide and TRC 102 by mouth once a day on days 1-5. Participants will keep a diary to record doses and any side effects.
* Treatment will be monitored with frequent blood tests and imaging studies. Tumor samples will also be collected.
* Participants will continue their treatment as long as the cancer does not grow and there are no severe side effects.

Conditions

• Lymphomas
• Solid Tumors
• NSCLC
• Metastatic Colon Carcinoma
• Granulosa 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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Alice P Chen, M.D. · National Cancer Institute (NCI)

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

120 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-07-12

Primary Completion

2023-08-01

Completion

2023-08-01

FDA Drug

Yes

Countries

• United States

Study Locations