Germ Cell TumorPhase 2NCT04804007
Maintenance Oral Etoposide or Observation Following High-dose Chemo for GCT
A Phase 2 study testing Etoposide in people with Germ Cell Tumor and Non-seminomatous Germ Cell Tumor, run by Nabil Adra at 1 site in United States.
Trial summary
This is an open label randomized phase II trial of maintenance oral etoposide vs. observation in patinets with relapsed GCT treated with high-dose chemotherapy (HDCT) and peripheral-blood stem-cell transplant (PBSCT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Germ Cell Tumor, Non-seminomatous Germ Cell Tumor, Ovarian Germ Cell Tumor
- What is being tested?
- Etoposide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2021to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent and HIPAA authorization for release of personal health information
- Age ≥ 18 years at the time of consent
- Histological or serological evidence of non-seminomatous GCT
- Relapsed disease after first-line cisplatin-based combination chemotherapy
- Completed salvage treatment with HDCT and PBSCT for 2 tandem cycles per Institutional Guidelines
- 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]
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- Normal or declining tumor markers (AFP and hCG) at time of screening
- Adverse events from prior therapy recovered to CTCAE v5.0 grade ≤ 2 at time of registration
- Women with ovarian germ cell tumors are eligible
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 within 28 days of study registration
- Last dose of HDCT must be ≤16 weeks from study registration
- 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
- 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.
- 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.
Who cannot join
- Relapsed pure seminoma
- Rising tumor markers (AFP and hCG) at time of screening
- Patients who completed 2nd cycle of HDCT (time since last dose of HDCT) >16 weeks ago
- Treatment with any investigational agent within 28 days prior to study registration
- Other active malignancy requiring treatment in past 12 months
- History of psychiatric illness or social situations that would limit compliance with study requirements
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- Active infection requiring systemic therapy
- Previous hypersensitivity to etoposide which did not recover with supportive care
- Pregnancy, lactation, or breastfeeding
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Christin Snow, RN, 317-274-5830, chsnow@iu.edu
Nabil Adra, MD
About this study
Official title: Randomized Phase 2 Trial of Maintenance Oral Etoposide or Observation Following High-dose Chemotherapy for Relapsed Metastatic Germ-Cell Tumor
This is an open label randomized phase II trial of maintenance oral etoposide vs. observation in patinets with relapsed GCT treated with high-dose chemotherapy (HDCT) and peripheral-blood stem-cell transplant (PBSCT).
Read the detailed description
This is a randomized phase 2 trial of maintenance etoposide versus observation following HDCT+PBSCT for relapsed GCT. Patients who completed HDCT+PBSCT within the past 16 weeks will enroll and randomize in 1:1 fashion to maintenance daily oral etoposide 50mg vs. observation only.
- Being tested
- Etoposide
- Keywords
- Germ Cell Tumor
- Medical subject headings
- Neoplasms, Germ Cell and Embryonal, Nonseminomatous germ cell tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtoposideDrug
etoposide will be provided with prescription for etoposide 50mg orally daily for 21 days out of 28 day cycles. Cycles will be repeated every 4 weeks for a total of 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Maintenance Oral Etoposide | Experimental | Maintenance daily oral Etoposide. Receives: Drug: Etoposide |
| Observation | No intervention | If randomized to Observation, subjects will jump to follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month Progression Free Survival
Investigator determination of tumor progression (clinical, radiographic, tumor markers including AFP and hCG)
Measured: time from the date of randomization to the date of disease relapse or death (i.e. up to 1 year)
Secondary outcomes (2)
12-month Overall Survival
Measured: Time of registration to death from any cause (i.e. up to 1 year)
Assess toxicity and tolerability of maintenance etoposide
Toxicities according to CTCAE v5 will be summarized by frequencies and rates calculated as the proportion of patients in the safety population experiencing SAEs, discontinuations due to AEs, and AEs.
Measured: through study completion (i.e. up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start3 Mar 2021
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Germ Cell TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients who completed HDCT+PBSCT within the past 16 weeks will enroll and randomize in 1:1 fashion in blocks of 8 to maintenance daily oral etoposide 50mg vs. observation only. Randomization will be stratified based on: -Presence of platinum refractory disease status defined by radiographic or serologic progression within 4 weeks of first-line cisplatin-based combination chemotherapy: yes vs. no
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nabil Adra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nabil Adra, Indiana University
- Investigators
- Nabil Adra, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804007
- Sponsor's protocol ID
- CTO-IUSCCC-0742
- Status last verified
- May 2026
- First submitted
- 15 Mar 2021
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Taza F, Abonour R, Zaid MA, Althouse SK, Anouti B, Akel R, Hanna NH, Adra N, Einhorn LH. Maintenance Oral Etoposide After High-Dose Chemotherapy (HDCT) for Patients With Relapsed Metastatic Germ-Cell Tumors (mGCT). Clin Genitourin Cancer. 2023 Apr;21(2):213-220. doi: 10.1016/j.clgc.2023.01.004. Epub 2023 Jan 18.
PubMed 36737276
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase 2 Trial of Maintenance Oral Etoposide or Observation Following High-dose Chemotherapy for Relapsed Metastatic Germ-Cell Tumor
- ClinicalTrials.gov ID
- NCT04804007
- Acronym / sponsor ID
- CTO-IUSCCC-0742
- Keywords
- Germ Cell Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Nabil AdraUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label randomized phase II trial of maintenance oral etoposide vs. observation in patinets with relapsed GCT treated with high-dose chemotherapy (HDCT) and peripheral-blood stem-cell transplant (PBSCT).
Detailed description
This is a randomized phase 2 trial of maintenance etoposide versus observation following HDCT+PBSCT for relapsed GCT. Patients who completed HDCT+PBSCT within the past 16 weeks will enroll and randomize in 1:1 fashion to maintenance daily oral etoposide 50mg vs. observation only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients who completed HDCT+PBSCT within the past 16 weeks will enroll and randomize in 1:1 fashion in blocks of 8 to maintenance daily oral etoposide 50mg vs. observation only. Randomization will be stratified based on: -Presence of platinum refractory disease status defined by radiographic or serologic progression within 4 weeks of first-line cisplatin-based combination chemotherapy: yes vs. no
| Arm | Type | Receives |
|---|---|---|
| Maintenance Oral Etoposide | Experimental | Drug: EtoposideMaintenance daily oral Etoposide. |
| Observation | No intervention | –If randomized to Observation, subjects will jump to follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Written informed consent and HIPAA authorization for release of personal health information
- Age ≥ 18 years at the time of consent
- Histological or serological evidence of non-seminomatous GCT
- Relapsed disease after first-line cisplatin-based combination chemotherapy
- Completed salvage treatment with HDCT and PBSCT for 2 tandem cycles per Institutional Guidelines
Key exclusion criteria (10 listed)
- Relapsed pure seminoma
- Rising tumor markers (AFP and hCG) at time of screening
- Patients who completed 2nd cycle of HDCT (time since last dose of HDCT) >16 weeks ago
- Treatment with any investigational agent within 28 days prior to study registration
- Other active malignancy requiring treatment in past 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etoposideetoposide will be provided with prescription for etoposide 50mg orally daily for 21 days out of 28 day cycles. Cycles will be repeated every 4 weeks for a total of 3 cycles. | Drug | Maintenance Oral Etoposide |
Primary outcome
12-month Progression Free Survival
Time frame: time from the date of randomization to the date of disease relapse or death (i.e. up to 1 year)
Investigator determination of tumor progression (clinical, radiographic, tumor markers including AFP and hCG)
2 secondary outcomes
12-month Overall Survival
Time frame: Time of registration to death from any cause (i.e. up to 1 year)
Assess toxicity and tolerability of maintenance etoposide
Time frame: through study completion (i.e. up to 2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Derived from this study: PubMed 36737276Taza F, Abonour R, Zaid MA, Althouse SK, Anouti B, Akel R, Hanna NH, Adra N, Einhorn LH. Maintenance Oral Etoposide After High-Dose Chemotherapy (HDCT) for Patients With Relapsed Metastatic Germ-Cell Tumors (mGCT). Clin Genitourin Cancer. 2023 Apr;21(2):213-220. doi: 10.1016/j.clgc.2023.01.004. Epub 2023 Jan 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nabil Adra, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Etoposide in people with Germ Cell Tumor and Non-seminomatous Germ Cell Tumor, run by Nabil Adra at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christin Snow, RN (317-274-5830, chsnow@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-month Progression Free Survival (time frame: time from the date of randomization to the date of disease relapse or death (i.e. up to 1 year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04804007, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.