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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04804007
Recruitment Status : Recruiting
First Posted : March 18, 2021
Last Update Posted : December 22, 2022
Sponsor:
Information provided by (Responsible Party):
Nabil Adra, Indiana University

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).

Condition or disease Intervention/treatment Phase
Germ Cell Tumor Non-seminomatous Germ Cell Tumor Ovarian Germ Cell Tumor Drug: Etoposide Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

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)
Primary Purpose: Treatment
Official Title: Randomized Phase 2 Trial of Maintenance Oral Etoposide or Observation Following High-dose Chemotherapy for Relapsed Metastatic Germ-Cell Tumor
Actual Study Start Date : March 3, 2021
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2026


Arm Intervention/treatment
Experimental: Maintenance Oral Etoposide
Maintenance daily oral Etoposide.
Drug: 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.

No Intervention: Observation
If randomized to Observation, subjects will jump to follow-up.



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 12-month Overall Survival [ Time Frame: Time of registration to death from any cause (i.e. up to 1 year) ]
  2. Assess toxicity and tolerability of maintenance etoposide [ Time Frame: through study completion (i.e. up to 2 years) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. 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 therapy
  14. 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.
  15. 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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04804007


Contacts
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Contact: Christin Snow, RN 317-274-5830 chsnow@iu.edu

Locations
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United States, Indiana
Indiana University Melvin & Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Christin Snow, RN    317-274-5830    chsnow@iu.edu   
Principal Investigator: Nabil Adra, MD         
Sponsors and Collaborators
Nabil Adra
Investigators
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Principal Investigator: Nabil Adra, MD Indiana University
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Responsible Party: Nabil Adra, Assistant Professor of Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT04804007    
Other Study ID Numbers: CTO-IUSCCC-0742
First Posted: March 18, 2021    Key Record Dates
Last Update Posted: December 22, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Nabil Adra, Indiana University:
Germ Cell Tumor
Additional relevant MeSH terms:
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Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Etoposide
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action