TRC102 and Temozolomide for Relapsed Solid Tumors and Lymphomas
- TRC102 is a new cancer treatment drug that may help improve the results of chemotherapy. It blocks tumor cells' attempts to repair damaged 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.
- To test the safety and effectiveness of TRC102 and temozolomide for advanced solid tumors and lymphomas.
- Individuals at least 18 years of age who have advanced solid tumors or lymphomas that have not responded to earlier treatments.
- 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.
|Lymphomas Solid Tumors NSCLC Metastatic Colon Carcinoma Granulosa Cell Ovarian Cancer||Drug: TRC 102||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Phase I Trial of TRC102 (Methoxyamine HCl) in Combination With Temozolomide in Patients With Relapsed Solid Tumors and Lymphomas|
- Establish safety, tolerability, and maximum tolerated dose of oral TRC102 in combination with oral TMZ in patients with refractory solid tumors. [ Time Frame: DLT determined first cycle (28) daysdays) ]
- To explore the response rate of this combination in patients with colon cancer, NSCLC, and granulosa cell ovarian cancer [ Time Frame: Response rate one year ]
- Evaluate the pharmacokinetic (PK) profile of oral TRC102 when administered in combination with TMZ [ Time Frame: First 5 days ]
- To explore the progression free survival rate of this combination in patients with colon cancer, NSCLC, and granulosa cell ovarian cancer [ Time Frame: Duration on study ]
|Study Start Date:||April 9, 2013|
|Estimated Study Completion Date:||December 24, 2019|
|Estimated Primary Completion Date:||December 24, 2019 (Final data collection date for primary outcome measure)|
Drug: TRC 102
Please refer to this study by its ClinicalTrials.gov identifier: NCT01851369
|Contact: Jennifer H Zlott||(301) email@example.com|
|Contact: Alice P Chen, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Alice P Chen, M.D.||National Cancer Institute (NCI)|