Pedmark + Cisplatin for Testicular Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: City of Hope Medical Center

Must be taking: Cisplatin

Must not be taking: Steroids, Loop diuretics

Disqualifiers: Brain metastases, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 30

Duration: 9-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding Pedmark to standard cisplatin chemotherapy can reduce hearing loss in men with stage II or III testicular cancer that has spread. Cisplatin, a common cancer drug, often damages the ears, leading to hearing loss in many patients. Pedmark might help by neutralizing harmful molecules that contribute to this hearing loss. Men diagnosed with metastatic testicular cancer and starting cisplatin-based chemotherapy could be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this potentially hearing-preserving treatment.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot use other ear-damaging drugs or chronic steroids above a certain dose. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that adding Pedmark to cisplatin-based chemotherapy might help reduce hearing loss in patients. Pedmark is already approved to prevent ear damage in children and some adults treated with cisplatin for other cancers, suggesting it could be a safe option for adults with testicular cancer as well.

Cisplatin, the main drug used in this treatment, effectively fights cancer but often causes hearing loss by creating harmful molecules that can damage the ear. Pedmark helps by neutralizing these molecules, potentially protecting hearing.

Previous studies with Pedmark have shown it to be well-tolerated, with no reports of severe side effects. This makes it a promising addition to the treatment plan for reducing hearing damage in patients using cisplatin. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Pedmark combined with cisplatin for testicular cancer because this pairing could reduce the harmful side effects typically seen with standard cisplatin therapy. While cisplatin alone is effective, it can cause significant side effects, including hearing loss. Pedmark is designed to protect the ears from this damage, offering a new protective mechanism alongside the usual treatment. This dual approach aims to maintain the powerful cancer-fighting ability of cisplatin while minimizing its impact on patients' quality of life.

What evidence suggests that adding Pedmark to cisplatin could reduce ototoxicity in testicular cancer treatment?

This trial will compare the effects of cisplatin alone with cisplatin combined with Pedmark. Studies have shown that adding Pedmark to cisplatin chemotherapy can reduce the risk of hearing loss caused by cisplatin. While cisplatin effectively treats testicular cancer, it often damages the ears, leading to hearing loss in about 80% of patients. Pedmark neutralizes harmful molecules created by cisplatin, which are believed to damage the ears. In previous research, patients who received Pedmark with cisplatin experienced a lower rate of hearing loss, with 44% affected compared to 58% of those who did not receive Pedmark. Pedmark is already approved for reducing hearing loss in children and some adults treated with cisplatin for other types of cancer. ^{1 2 6 7 8}

Who Is on the Research Team?

Alex Chehrazi-Raffle

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for men with stage II-III metastatic testicular germ cell tumors. Participants should be experiencing or at risk of drug-induced hearing loss due to cisplatin chemotherapy. The study excludes individuals who don't meet the specific cancer staging criteria, have other health conditions that could interfere with the trial, or are unable to undergo procedures like MRI or CT scans.

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

Exclusion Criteria

Patient must adhere to low sodium diet given other comorbidities

History of severe hypersensitivity to sodium thiosulfate or any components such as sulfites or thiols

Greater than or equal to moderate hearing loss (HL) at baseline per World Health Organization (WHO) classification

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cisplatin-based chemotherapy with or without Pedmark for 3-4 cycles, each cycle lasting 21 days

9-12 weeks

Multiple visits for each cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments for ototoxicity and disease progression

Up to 6 months

Follow-up at 30 days, every 3 months for 1 year, then per SOC for year 2

Long-term follow-up

Participants are monitored for progression-free survival and long-term outcomes

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Cisplatin
• Pedmark

Trial Overview The trial is testing Pedmark added to standard cisplatin chemotherapy to see if it can reduce ear damage caused by the treatment in adult men. Cisplatin is known for causing hearing loss, and Pedmark may neutralize harmful molecules responsible for this side effect.

How Is the Trial Designed?

Group I: Arm II (SOC cisplatin, Pedmark) Experimental Treatment 5 Interventions

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.

Group II: Arm I (SOC cisplatin) Active Control 4 Interventions

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.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. trial.medpath.com trial.medpath.com/clinical-trial/924569d502189991/nct07218913-pedmark-cisplatin-chemotherapy-ear-damage-testicular-germ-cell-tumors

Testing the Addition of Pedmark to Cisplatin Chemotherapy for ... Adding Pedmark to cisplatin-based chemotherapy treatment may reduce ototoxicity in adult men with stage I-III testicular metastatic germ cell ...

2. testicularcancerawarenessfoundation.org testicularcancerawarenessfoundation.org/in-the-news/cisplatin-and-ototoxicity-the-hidden-impact-on-hearing

Cisplatin and Ototoxicity: The Hidden Impact of Hearing Loss While cisplatin is highly effective in curing testicular cancer, it comes with a serious side effect: hearing loss, also known as “Ototoxicity."

3. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/212937s000lbl.pdf

212937s000lbl.pdf - accessdata.fda.gov The safety and effectiveness of PEDMARK have been established to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age ...

4. targetedonc.com targetedonc.com/view/fda-accepts-resubmitted-nda-for-pedmark-in-cisplatin-induced-ototoxicity

FDA Accepts Resubmitted NDA for Pedmark in Cisplatin ... The 3-year OS rate at a median follow-up of 52 months was 98% (95% CI, 88%-100%) when given the combination of cisplatin and sodium thiosulfate ...

5. onclive.com onclive.com/view/pedmark-reduces-ototoxicity-risk-in-cisplatin-treated-pediatric-solid-tumors

Pedmark Reduces Ototoxicity Risk in Cisplatin-Treated ... Incidence of hearing loss was also lower in patients who received the combination in this trial, at 44% vs 58% in those who received cisplatin ...

6. oncologynews.com.au oncologynews.com.au/latest-news/chemo-drug-may-cause-significant-hearing-loss-in-longtime-cancer-survivors/

Chemo drug may cause significant hearing loss in longtime ... The research team found higher doses of cisplatin led to more severe and progressing hearing loss, especially in patients with risk factors.

7. ncoda.org ncoda.org/wp-content/uploads/2025/03/PQI-Sodium-Thiosulfate-Pedmark-for-cisplatin-induced-ototoxicity-11.22.24.pdf

PQI-Sodium-Thiosulfate-Pedmark-for-cisplatin-induced- ... Description: This PQI aims to provide clinical data on the use, administration, and timing of sodium thiosulfate (STS) injection to prevent platinum-induced ...

8. ecancer.org ecancer.org/en/news/24954-chemo-drug-may-cause-significant-hearing-loss-in-longtime-cancer-survivors

Chemo drug may cause significant hearing loss in longtime ... The research team found higher doses of cisplatin led to more severe and progressing hearing loss, especially in patients with risk factors.