Could a simple pill keep relapsed testicular cancer at bay?
NCT ID NCT04804007
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is for people with relapsed germ cell tumors (a type of cancer often in the testicles or ovaries) who have already had high-dose chemotherapy and a stem cell transplant. It tests whether taking a daily oral chemotherapy drug called etoposide for a while after treatment can help keep the cancer from coming back, compared to just watching and waiting. The trial will enroll 64 adults and track cancer progression and side effects over 12 months.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 64 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2021
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Written informed consent and HIPAA authorization for release of personal health information 2. Age ≥ 18 years at the time of consent 3. Histological or serological evidence of non-seminomatous GCT 4. Relapsed disease after first-line cisplatin-based combination chemotherapy 5. Completed salvage treatment with HDCT and PBSCT for 2 tandem cycles per Institutional Guidelines 6. HDCT must have been used as the initial salvage chemotherapy regimen (2nd line therapy) 6.1. Note: 1 or 2 cycles of standard course regimens prior to HDCT are acceptable (regimens include VeIP \[vinblastine+ifosfmaide+cisplatin\] or TIP \[paclitaxel+ifosfamide+cisplatin\] or PVB \[cisplatin+vinblastine+bleomycin\] 7. Normal or declining tumor markers (AFP and hCG) at time of screening 8. Adverse events from prior therapy recovered to CTCAE v5.0 grade ≤ 2 at time of registration 9. Women with ovarian germ cell tumors are eligible 10. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 within 28 days of study registration 11. Last dose of HDCT must be ≤16 weeks from study registration 12. Adequate organ function lab values obtained within 28 days prior to study registration System Laboratory Value Hematological Absolute neutrophil count (ANC) ≥1,000 /mcL Platelets ≥100,000 / mcL Hemoglobin ≥8 g/dL Renal Serum creatinine \<2mg/dL Hepatic Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \> 1.5 ULN AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR * 5 X ULN for subjects with liver metastases Coagulation International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants 13. If a female of childbearing potential, a negative urine pregnancy test within 28 days prior to receiving the first dose of study drug. o Non-childbearing potential is defined as (by other than medical reasons): * ≥ 45 years of age and has not had menses for \>2 years * Amenorrheic for \< 2 years without a hysterectomy and/or oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation * Post hysterectomy or oophorectomy. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. 14. For female patients of childbearing potential and male patients, agreement (by patient and/or partner) to use two forms of highly effective contraception (i.e., one that results in a low failure rate \[\< 1% per year\] when used consistently and correctly) starting with the first dose of study therapy and to continue its use for 30 days after the last dose of study therapy, or abstain from heterosexual activity. Exclusion Criteria: 1. Relapsed pure seminoma 2. Rising tumor markers (AFP and hCG) at time of screening 3. Patients who completed 2nd cycle of HDCT (time since last dose of HDCT) \>16 weeks ago 4. Treatment with any investigational agent within 28 days prior to study registration 5. Other active malignancy requiring treatment in past 12 months 6. History of psychiatric illness or social situations that would limit compliance with study requirements 7. Active infection requiring systemic therapy 8. Previous hypersensitivity to etoposide which did not recover with supportive care 9. Pregnancy, lactation, or breastfeeding 10. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Indiana University Melvin & Bren Simon Cancer Center
RECRUITINGIndianapolis, Indiana, 46202, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- High-Dose chemo with stem cell transplant tested against standard therapy for tough germ cell cancers
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- Dietary change explored as cancer support strategy
- Hypnosis may ease chemo anxiety in teens and young adults
- Massive ovarian cancer screening trial tests whether early detection cuts deaths