For mesothelioma patients and families who are interested in clinical trials, researching clinical trials and eligibility can be a time consuming barrier to participation. The information about clinical trials is available on www.clinicaltrials.gov.
Our goal is to feature one mesothelioma clinical trial monthly and break it down to understandable terms, to decipher the eligibility requirements, and to possibly encourage participations in these trials.
CLINICAL TRIAL- NCT02535312
Methoxyamine (TRC102), Cisplatin, and Pemetrexed Disodium in Treating Patients with Advanced Solid Tumors or Mesothelioma That Cannot Be Removed by Surgery or Mesothelioma That is Refractory to Cisplatin and Pemetrexed
Official Title- Phase I Study of TRC102 in Combination with Cisplatin and Pemextred in Patients with Advanced Solid Tumors, With Expansion Cohort in Mesothelioma/ Phase II Study of TRC102 with Pemetrexed in Patients Refractory to Cisplatin and Pemetrexed
Listing on www.clinicaltrials.gov
Sponsor- National Cancer Institute
Location- University of Maryland/ Greenebaum Cancer Center Baltimore Maryland- Contact Martin J. Edelman 800-888-8823
City of Hope Comprehensive Cancer Center Duarte, California, Contact Marianna Koczywas 800-826-4673
University of California Davis Comprehensive Cancer Center Sacramento, California, Contact Karen L. Kelly 916-734-7946
University of Colorado Cancer Center- Anschutz Cancer Pavilion Aurora, Colorado, Contact Stephen Leong 720- 848-0650
University of Michigan Comprehensive Cancer Center Ann Arbor Michigan, Contact Bryan J. Schneider
Mayo Clinic Rochester, Minnesota, United States Contact: Aoron S. Mansfield 507-538-7623
Number of Participants-58
Purpose- Clinical Trial TRC 102 in combination with 2 chemotherapy agents Cisplatin and Pemetrexed. This trial is for advanced tumors with expansion to mesothelioma/ Phase II is TRC102 and Pemetrexed in patients with refractory to cisplatin and Pemetrexed. NCI 9837
Group 1 is for previously treated cancers. Different doses of the study drug will be distributed in conjunction with Pemetexed and Cisplatin in patients who have been previously treated. The first group will receive the lowest dose of TRc102. If this does not cause serious side effects the dose will be increased for the next group of patients. The dose will be increased for each group until the side effects require the dose to be lowered.
Group 2 is for newly diagnosed patients with mesothelioma or solid tumors. The study drug TRC102 will be given in addition to Pemetrexed and Cisplatin. This group will be patients who would have been prescribed Pemetrexed and Cisplatin for regular treatment. The solid cancers include malignant mesothelioma, non small cell lung cancer, ovarian and thymome. The dose of group one will be based on the study of group 1.
Group 3 is for newly diagnosed malignant mesothelioma. All study participants will get the same drug (TRC102) with Pemetrexed and Cisplatin. This is for 14 study participants with previously untreated advanced, inoperable malignant mesothelioma for which Pemetrexed and Cisplatin is the regular treatment. The dose of TRC102 will be based on group 1.
Pemextred and Cisplatin will be given in conjunction with TRC102 on the first day of each cycle for 6 cycles. A treatment cycle is 3 weeks.
1 Patients with advance tumors in which standard treatments are not available. (Arm A)
2.Patients who have advanced unresectable solid tumors that are chemotherapy naïve for which Pemextred and Cisplatin is an indicated regime. (Arm A)
3.Group 3 patients with chemotherapy naïve and unrespectable malignant mesothelioma. ( Arm A)
4.Patients who have been treated but disease has progressed within 3 months of being treated with Cisplatin and Pemetrexed as a frontline appointment. (pleural or peritoneal mesothelioma) (Arm B)
5.Prior Pemetrexed dose for treatment but Cisplatin does can be no more than 75mg/2.
6 Male or Females greater than 18 years of age
7.Perfomance status is 0-1 Karnofsky greater than 70%
8.Life expectancy is greater than 3 months
9.Patients must have normal organ and marrow function
10. For patients who are in Arm A or Arm B, the disease must be measurable (pleural effusions and ascites are not measurable disease)
11. Patients must be able to swallow whole capsules. Nasogastric tubes or G tubes are not acceptable
12. Since this is a clinical trial it is unknown the effects to unborn fetus. Patients must agree to adequate contraception for the duration of trial
- Patients who have received chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Patients who have targeted therapy will have to wait 2 weeks due to short life of drugs.
- Patients who are receiving any other investigational drugs
- Patient with active brain metastases. Patients with treated brain metastases and have remained stable for greater than 4 weeks, without steroid and anti -seizure medicine, are able to participate. History of allergic reactions to compound or similar ingredients to TRC102 or Pemextred and Cisplatin
- As part of the informed consent patients will be counseled on the risk of over-the-counter medication or new prescription medications.
- Uncontrolled illness
- Pregnant and breastfeeding
- HIV patients on anti-viral therapy are ineligible
- Patients with known disorders that have hemolysis
- Patients on anticoagulation and thromboembolic disease
- Uncontrolled malignant pleural effusion or ascites
- Patients who have a cumulative does of Cisplatin greater than 300M2
How the research study is designed to work- Methoxyamine, or TRC102 is a medication taken by mouth? It is a small molecule inhibitor with potential adjuvant activity. It works by binding apurinic / apyrimidinic (AP) DNA damage sites and inhibits base excision repair (BER) which may result in an increase in DNA strand break and apoptosis. Apoptosis equals cell death. This agent may potentiate the anti- tumor activity of alkylating agents. The different arms of the study are trying the medications with certain cancers at different points. This study is being done concurrently with other cancers as well as mesothelioma.
With any clinical trial, all participation is voluntary. Before enrollment a detailed consent form will be reviewed with the participant and signed.
The participant can withdraw from a clinical trial at any point in time. Think about participating if you are able.
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