This phase I trial evaluates whether adding Pedmark to standard of care cisplatin-based chemotherapy reduces drug-induced ear damage (ototoxicity) in men with stage II-III testicular germ cell tumors that have spread from where they first started (primary site) to other places in the body (metastatic). Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Cisplatin-induced ototoxicity remains a major concern in adult patients with germ cell tumors as nearly four out of five patients develop hearing loss after treatment. Cisplatin is thought to cause ear damage by the production of chemically reactive molecules called reactive oxygen species. These molecules can cause damage when their levels get too high. Pedmark may reduce the negative side effects of cisplatin by neutralizing these reactive molecules. Pedmark has been approved for reducing the risk of cisplatin-induced ototoxicity in pediatric patients and older patients with solid tumors that haven't spread to other parts of the body. Adding Pedmark to cisplatin-based chemotherapy treatment may reduce ototoxicity in adult men with stage I-III testicular metastatic germ cell tumors.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07218913.
Locations matching your search criteria
United States
California
Duarte
City of Hope Comprehensive Cancer CenterStatus: Active
Contact: Alex Chehrazi-Raffle
Phone: 626-218-4772
PRIMARY OBJECTIVE:
I. Evaluate the incidence of clinically meaningful ototoxicity in adults with metastatic germ cell tumor (GCT) receiving sodium thiosulfate anhydrous (Pedmark) plus cisplatin-based chemotherapy compared to those receiving cisplatin-based chemotherapy alone.
SECONDARY OBJECTIVES:
I. Assess the incidence of high-frequency ototoxicity (affecting frequencies within 8000-12,500 Hz) between adults in both arms.
II. Assess the severity and progression of ototoxicity between adults in both arms.
III. Determine the safety and tolerability of Pedmark plus cisplatin-based chemotherapy compared to cisplatin-based chemotherapy alone.
IV. Examine the efficacy of Pedmark plus cisplatin-based chemotherapy compared to cisplatin-based chemotherapy alone.
EXPLORATORY OBJECTIVES:
I. Evaluate the incidence of tinnitus between adults in both arms.
II. Disease assessment 6 months post-primary treatment in both arms.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive cisplatin intravenously (IV) over 60 minutes on days 1-5 or 2-5 of each standard of care (SOC) cisplatin-based chemotherapy regimen cycle. Cycles repeat every 21 days for 3-4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) throughout the trial.
ARM II: Patients receive cisplatin IV over 60 minutes on days 1-5 or 2-5 of each SOC cisplatin-based chemotherapy regimen cycle. Patients also receive Pedmark IV over 30 minutes, 6 hours after each SOC cisplatin infusion, on days 1-5 or 2-5 of each cycle. Cycles repeat every 21 days for 3-4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI throughout the trial.
After completion of study treatment, patients are followed up at 30 days, every 3 months for 1 year and then per SOC for year 2.
Lead OrganizationCity of Hope Comprehensive Cancer Center
Principal InvestigatorAlex Chehrazi-Raffle
