OncoMatch/Clinical Trials/NCT07218913
Testing the Addition of Pedmark to Cisplatin Chemotherapy for Reducing Drug-Induced Ear Damage in Men With Stage II-III Metastatic Testicular Germ Cell Tumors
Is NCT07218913 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Cisplatin and Sodium Thiosulfate Anhydrous for hearing loss.
Treatment: Cisplatin · Sodium Thiosulfate Anhydrous — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Testicular Germ Cell Tumor
Disease stage
Required: Stage II, III
Metastatic disease required
Prior therapy
Must have received: cisplatin-based chemotherapy (cisplatin) — first or second line
Receiving first or second line cisplatin-based chemotherapy
Cannot have received: cisplatin-based chemotherapy (cisplatin)
Any cisplatin-based therapies within 4 weeks prior to initiation of study treatment
Lab requirements
Blood counts
ANC ≥ 1,500/mm³; Platelets ≥ 100,000/mm³ (no transfusion within 14 days unless cytopenia secondary to disease); Hemoglobin ≥ 9g/dL (no transfusion within 14 days unless cytopenia secondary to disease)
Kidney function
Creatinine clearance of ≥ 60 mL/min per Cockcroft-Gault or serum creatinine ≤ 1.5 x ULN
Liver function
Total bilirubin ≤ 1.5 X ULN (Gilbert disease < 3 x ULN may enroll); AST ≤ 3.0 x ULN; ALT ≤ 3.0 x ULN
ANC ≥ 1,500/mm³; Platelets ≥ 100,000/mm³; Hemoglobin ≥ 9g/dL; Total bilirubin ≤ 1.5 X ULN; AST ≤ 3.0 x ULN; ALT ≤ 3.0 x ULN; Creatinine clearance of ≥ 60 mL/min per Cockcroft-Gault or serum creatinine ≤ 1.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
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