Oral Etoposide for Germ Cell Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new use for the drug etoposide (also known as Eposin, VP-16, or Vepesid) to assist individuals with germ cell tumors (GCT) that have recurred after previous treatments. The trial aims to determine if regular oral administration of etoposide can improve outcomes compared to observation without additional treatment. Ideal participants have already undergone high-dose chemotherapy and a stem-cell transplant and currently show stable or decreasing tumor markers (substances in the blood that can indicate cancer). The study includes both active treatment and observation groups to compare results. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that etoposide is generally well-tolerated by patients with various types of cancer. It often treats cancers such as testicular, prostate, and lung cancer. In one study, etoposide was part of successful treatment plans for patients with germ-cell cancer.
However, like many treatments, etoposide can cause side effects. A study examining real-world data found that while some unexpected medical problems can occur, they are usually manageable. The most common side effects include low blood cell counts, which can increase the risk of infection, and mild nausea.
Overall, evidence suggests that etoposide is a safe option for many people, especially when used under careful medical supervision. Discussing potential risks with a healthcare provider before joining a clinical trial is always important.12345Why do researchers think this study treatment might be promising for germ cell cancer?
Unlike the standard treatments for germ cell cancer, which often involve intravenous chemotherapy, oral etoposide offers a convenient oral administration. This delivery method can make treatment more accessible and less burdensome for patients who prefer taking medication at home instead of visiting a clinic for infusions. Researchers are excited about this option because it maintains the effectiveness of traditional etoposide while potentially improving quality of life and adherence to treatment.
What evidence suggests that oral etoposide could be an effective treatment for germ cell cancer?
Research has shown that oral etoposide may help treat relapsed germ cell tumors (GCT) after high-dose chemotherapy and stem-cell transplants. In this trial, participants in the "Maintenance Oral Etoposide" arm will receive daily oral etoposide. One study found that patients who took oral etoposide daily had a 55% chance of their cancer not worsening over two years, compared to 44% for those who did not take the drug. The overall survival rate was also better, with 61% of patients on etoposide living for at least two years, compared to 52% in the group that did not take it. Additionally, about 74% of patients on etoposide were free of the disease after around three years. These results suggest that oral etoposide can effectively manage relapsed GCT.56789
Who Is on the Research Team?
Nabil Adra, MD
Principal Investigator
Indiana University
Are You a Good Fit for This Trial?
Adults over 18 with relapsed non-seminomatous germ cell tumors (GCT) who've had high-dose chemotherapy and stem-cell transplant. They must have normal or improving tumor markers, good organ function, no active infections, and not be pregnant or breastfeeding. Participants need to agree to use effective contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive maintenance daily oral etoposide or are observed following high-dose chemotherapy and peripheral-blood stem-cell transplant
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Etoposide
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nabil Adra
Lead Sponsor