Maintenance Oral Etoposide or Observation Following High-dose Chemo for GCT

  • End date
    Dec 8, 2026
  • participants needed
  • sponsor
    Nabil Adra
Updated on 8 March 2022
tumor markers
human chorionic gonadotropin
neutrophil count
high-dose chemotherapy
cancer chemotherapy
alpha fetoprotein


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).


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.

Condition Germ Cell Tumor, Non-seminomatous Germ Cell Tumor, Ovarian Germ Cell Tumor
Treatment etoposide
Clinical Study IdentifierNCT04804007
SponsorNabil Adra
Last Modified on8 March 2022


Yes No Not Sure

Inclusion Criteria

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]
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
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
Non-childbearing potential is defined as (by other than medical reasons)
Male subjects should agree to use an adequate method of contraception starting with
the first dose of study therapy through 30 days after last dose of study
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
If a female of childbearing potential, a negative urine pregnancy test within 28 days prior to receiving the first dose of study drug
≥ 45 years of age and has not had menses for >2 years
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 with partners of
childbearing potential, 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) and to continue its
use for 30 days after the last dose of study therapy

Exclusion Criteria

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
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note