64 Participants Needed

Oral Etoposide for Germ Cell Cancer

CS
Overseen ByChristin Snow, RN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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.12345

Why 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 | IU Health

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

I am not able to have children due to age, surgery, or menopause.
My cancer is a type of non-seminoma based on tests.
My cancer returned after first treatment with a cisplatin combo.
See 21 more

Exclusion Criteria

Previous hypersensitivity to etoposide which did not recover with supportive care
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
My seminoma cancer has come back after treatment.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive maintenance daily oral etoposide or are observed following high-dose chemotherapy and peripheral-blood stem-cell transplant

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Etoposide
Trial Overview This phase II trial is testing if taking oral Etoposide after high-dose chemo helps patients with GCT more than just monitoring them without treatment. It's an open label study, meaning everyone knows which treatment they're getting.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Maintenance Oral EtoposideExperimental Treatment1 Intervention
Group II: ObservationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nabil Adra

Lead Sponsor

Trials
5
Recruited
190+

Published Research Related to This Trial

In a Phase II study involving 20 patients with hormone-refractory prostate carcinoma, the oral combination of cyclophosphamide and etoposide showed a 35% objective response rate, with one complete response and six partial responses based on PSA levels.
The treatment was well tolerated, with minimal toxicities, and resulted in improved performance status for 26% of patients and relief of bone pain in 71%, indicating its potential efficacy in managing symptoms and disease progression.
Phase II study of the oral cyclophosphamide and oral etoposide combination in hormone-refractory prostate carcinoma patients.Maulard-Durdux, C., Dufour, B., Hennequin, C., et al.[2019]
In a phase II trial involving 22 patients with recurrent ovarian carcinoma, oral etoposide (VP-16-213) showed some antitumor activity, with one patient achieving a complete response and another a partial response.
The treatment was associated with significant toxicity, as 14 patients experienced grade 3-4 hematologic toxicity, highlighting the need for careful monitoring during therapy.
Phase II clinical trial of VP-16-213 (etoposide) administered orally in advanced ovarian cancer.Hansen, F., Malthe, I., Krog, H.[2019]
The absolute oral bioavailability of etoposide in cancer patients ranges from 48% to 57%, indicating that nearly half of the orally administered dose is effectively absorbed into the bloodstream.
Significant variability in pharmacokinetics was observed among patients, suggesting that individual factors greatly influence how etoposide is processed, highlighting the need for personalized dosing strategies in cancer treatment.
Bioavailability and pharmacokinetics of etoposide (VP-16).Smyth, RD., Pfeffer, M., Scalzo, A., et al.[2013]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36737276/
Maintenance Oral Etoposide After High-Dose ...Conclusion: Daily oral etoposide therapy produced encouraging efficacy results in patients with relapsed non-seminoma GCT (NSGCT) who completed HDCT and PBSCT ...
Maintenance oral etoposide (VP-16) after high-dose ...Results: 2-year PFS in the maintenance VP-16 versus observation group was 55% vs. 44% (p = 0.008). 2-year OS was 61% vs. 52% (p = 0.01). A ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/7738621/
Maintenance chemotherapy with daily oral etoposide ...Seventeen (74%) remain continuously disease-free, with a median follow-up time of 36 months (range, 26 to 49) from initiation of daily oral VP-16. Eleven ...
Maintenance Oral Etoposide After High-Dose ...Daily oral etoposide therapy produced encouraging efficacy results in patients with relapsed non-seminoma GCT (NSGCT) who completed HDCT and PBSCT.
Maintenance Oral Etoposide After High-Dose ...46% (P=0.028). 2-year overall survival (OS) was 61% in maintenance etoposide group vs 54% in the observation group (P=0.04). A multivariable ...
Etoposide - StatPearls - NCBI Bookshelf - NIHEtoposide is a medication used in the management and treatment of various cancers such as testicular, prostate, bladder, stomach, and lung cancer.
Etoposide, VP-16Randomized trial of etoposide and cisplatin versus etoposide and carboplatin in patients with good-risk germ cell tumors: a multi-institutional ...
A pharmacovigilance study of etoposide in the FDA ...This study aimed to assess and evaluate etoposide-related adverse events in a real-world setting by using data mining method on the US Food and Drug ...
ETOPOSIDE 1. Exposure Data(1993) reviewed the records of 538 previously untreated patients with (disseminated) germ-cell cancer entering clinical trials between 1982 and 1991,. ETOPOSIDE.
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