Recruiting
Phase 2

Etoposide vs. Observation

Sponsor:

Nabil Adra

Code:

NCT04804007

Conditions

Germ Cell Tumor

Non-seminomatous Germ Cell Tumor

Ovarian Germ Cell Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Etoposide

Study Details

Brief 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).

Conditions

Germ Cell Tumor

Non-seminomatous Germ Cell Tumor

Ovarian Germ Cell Tumor

Study ID

NCT04804007

Start date

Mar 3, 2021

Status verified date

May, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Maintenance Oral Etoposide

Maintenance daily oral Etoposide.

no intervention: Observation

If randomized to Observation, subjects will jump to follow-up.

Interventions

Etoposide

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.

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) ]

Central Contacts and Locations

Central contacts

Locations

Indiana University Melvin & Bren Simon Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Principal Investigator:

Nabil Adra, MD

More Information

Sponsor

Nabil Adra

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • Germ Cell Tumor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nabil Adra on 2026-05-08.