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

N
Nabil Adra, MD

Primary Investigator

Enrolling By Invitation
18 years and older
All
Phase 2
64 participants needed
2 Locations

Overview

This is an open label randomized phase II trial of maintenance oral etoposide vs. observationwith relapsed GCT treated with high-dose chemotherapy (HDCT) and peripheral-blood(PBSCT).

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 willd randomize in 1:1 fashion to maintenance daily oral etoposide 50mg vs. observationy.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Germ Cell Tumor, Non-seminomatous Germ Cell Tumor, Ovarian Germ Cell Tumor
  • Age: 18 Years
  • Gender: All

Inclusion Criteria:
  1. Written informed consent and HIPAA authorization for release of personal health
  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 InstitutionalGuidelines
  6. HDCT must have been used as the initial salvage chemotherapy regimen (2nd lineherapy) 6.1. Note: 1 or 2 cycles of standard course regimens prior to HDCT areble (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 ofgistration
  9. Women with ovarian germ cell tumors are eligible
  10. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 within 28days 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 registrationystem Laboratory Value Hematological Absolute neutrophil count (ANC) ≥1,000 /mcLPlatelets ≥100,000 / mcL Hemoglobin ≥8 g/dL Renal Serum creatinine <2mg/dL Hepaticum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with totalbilirubin levels > 1.5 ULN
    AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR
    • 5 X ULN for subjects with liver metastases Coagulation International NormalizedRatio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receivinggulant therapy as long as PT or PTT is within therapeutic range ofded use of anticoagulants Activated Partial Thromboplastin Time (aPTT) ≤1.5LN unless subject is receiving anticoagulant therapy as long as PT or PTT iswithin 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 daysving the first dose of study drug.
    • 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 aulating hormone value in the postmenopausal range upon pre-study(screening) evaluation
      • Post hysterectomy or oophorectomy. Documented hysterectomy or oophorectomy mustbe confirmed with medical records of the actual procedure or confirmed by anultrasound.
  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 ofhighly effective contraception (i.e., one that results in a low failure rate [< 1% peryear] when used consistently and correctly) and to continue its use for 30 days afterhe 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 withudy 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 abnormalityhat might confound the results of the trial, interfere with the subject'she full duration of the trial, or is not in the best interest ofhe subject to participate, in the opinion of the treating investigator.

Updated on 15 May 2024. Study ID: CTO-IUSCCC-0742
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