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

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Brief Title

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

Official Title

Randomized Phase 2 Trial of Maintenance Oral Etoposide or Observation Following High-dose Chemotherapy for Relapsed Metastatic Germ-Cell Tumor

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).
    

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/m2 vs.
      observation only.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

12-month Progression Free Survival

Secondary Outcome

 12-month Overall Survival

Condition

Germ Cell Tumor

Intervention

Etoposide

Study Arms / Comparison Groups

 Maintenance Oral Etoposide
Description:  Maintenance daily oral Etoposide.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

64

Start Date

March 3, 2021

Completion Date

December 2024

Primary Completion Date

December 2023

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Nabil Adra, MD, 317-274-5830, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04804007

Organization ID

CTO-IUSCCC-0742


Responsible Party

Sponsor-Investigator

Study Sponsor

Nabil Adra


Study Sponsor

Nabil Adra, MD, Principal Investigator, Indiana University


Verification Date

March 2021