TRC102 and Temozolomide for Relapsed Solid Tumors and Lymphomas
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|ClinicalTrials.gov Identifier: NCT01851369|
Recruitment Status : Recruiting
First Posted : May 10, 2013
Last Update Posted : December 10, 2019
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphomas Solid Tumors NSCLC Metastatic Colon Carcinoma Granulosa Cell Ovarian Cancer||Drug: TRC 102||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Trial of TRC102 (Methoxyamine HCl) in Combination With Temozolomide in Patients With Relapsed Solid Tumors and Lymphomas|
|Actual Study Start Date :||July 16, 2013|
|Estimated Primary Completion Date :||December 24, 2020|
|Estimated Study Completion Date :||February 1, 2021|
combination treatment with oral TRC102 and oral TMZ for days 1-5 of 28-day cycles
Drug: TRC 102
TRC102 has been shown to potentiate the activity of temozolomide by preventing BER and allowing cleavage of TRC102 bound DNA, which will cause DNA strand breaks in cancer cells. We hypothesize that oral TRC102 can be safely co-administered with TMZ and would potentiate DNA damage caused by TMZ resulting in antitumor responses.
- Evaluate the pharmacokinetic (PK) profile of oral TRC102 when administered in combination with TMZ [ Time Frame: First 5 days ]Blood and urine pharmacokinetics will be assessed in the phase Iportion of the study.
- To establish the safety, tolerability, and maximum tolerated dose (MTD) of oral TRC102 in combination with oral TMZ in patients with refractory solid tumors. [ Time Frame: DLT determined first cycle (28 days) ]Adverse events will be characterized using the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
- 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 ]Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1).
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851369
|Contact: Jennifer H Zlott||(240) firstname.lastname@example.org|
|Contact: Alice P Chen, M.D.||(240) email@example.com|
|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)|