Pedmark added to cisplatin to protect hearing in men with testicular germ cell tumors

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adult men with testicular germ cell tumor that has spread (stage II or III). They must be getting cisplatin-based chemotherapy. The trial tests whether Pedmark protects hearing.

Age

18 years and older

Sex

Men only

Disease stage

Germ cell tumor (seminoma or non-seminoma) confirmed by tissue test, spread to other parts of the body (stage II or III). Disease must be measurable on scans (RECIST 1.1). ECOG 0 or 1 or Karnofsky score ≥ 70.

Earlier treatment

Must be receiving first or second line cisplatin-based chemotherapy, with a planned total cisplatin dose of ≥ 300mg/m^2 (including previous treatment). Must have recovered from side effects of earlier cancer treatment to grade 1 or less (hair loss allowed). No cisplatin-based therapy within 4 weeks before study treatment.

Main reasons for not taking part

• Moderate or worse hearing loss at the start
• Brain metastases that cause symptoms, cancer in the brain lining, or past radiation to the head
• Use of other drugs that can harm hearing, such as loop diuretics or aminoglycosides
• Severe allergy to sodium thiosulfate, sulfites or thiols
• Unable to have cisplatin due to heart, kidney or nerve problems or poor general health; or unstable heart disease

The registry criteria, word for word

What the trial wants to find out

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.

The 2 groups in the trial

• Arm I (SOC cisplatin)Existing treatment, for comparison

  Patients receive cisplatin IV over 60 minutes on days 1-5 or 2-5 of each 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 CT and/or MRI throughout the trial.

  Treatment: Audiometric Test, Cisplatin, Computed Tomography, and Magnetic Resonance Imaging

• Arm II (SOC cisplatin, Pedmark)Treatment being tested

  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.

  Treatment: Audiometric Test, Cisplatin, Computed Tomography, Magnetic Resonance Imaging, and Sodium Thiosulfate Anhydrous