Phase 1 Trial of Pedmark in Men Receiving Cisplatin for Metastatic Germ Cell Tumor
City of Hope Medical Center
Summary
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.
Description
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 chemothe…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines * Willing and able to sign informed consent form * Willing and able to participate in baseline and serial audiometry exams * Age: ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) of 0 or 1 or Karnofsky score ≥ 70 * Histologically confirmed germ cell tumor (seminoma or non-seminoma) * Presence of metastatic disease (stage II or III) * Fully recovered from the acute toxic effects (except alopecia) to ≤ gr…
Interventions
- ProcedureAudiometric Test
Ancillary studies
- DrugCisplatin
Given IV
- ProcedureComputed Tomography
Undergo CT
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- DrugSodium Thiosulfate Anhydrous
Given IV
Location
- City of Hope Medical CenterDuarte, California