Accelerated vs Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours

Overview

About this study

The purpose of this study is to determine whether accelerated BEP chemotherapy is more effective than standard BEP chemotherapy in males with intermediate and poor-risk metastatic germ cell tumours.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥ 11 years and ≤ 45 years on the date of randomisation.
  • Histologically or cytologically confirmed germ cell tumour (non-seminoma or seminoma); or exceptionally raised tumour markers (AFP ≥ 1000ng/mL and/or HCG ≥ 5000 IU/L) without histologic or cytologic confirmation in the rare case where pattern of metastases consistent with GCT, high tumour burden, and a need to start therapy urgently.
  • Primary arising in testis, ovary, retro-peritoneum, or mediastinum.
  • Metastatic disease or non-testicular primary.
  • Intermediate or poor prognosis as defined by IGCCC classification3 (modified with different LDH criteria for intermediate risk non-seminoma, and inclusion of ovarian primaries)..
  • Adequate bone marrow function with ANC ≥1.0 x 10^9/L, Platelet count ≥100 x 10^9/L.
  • Adequate liver function where bilirubin must be ≤ 1.5 x ULN, except participants with Gilbert's Syndrome where bilirubin must be ≤ 2.0 x ULN; ALT and AST must be ≤ 2.5 x ULN, except if the elevations are due to hepatic metastases, in which case ALT and AST must be ≤ 5 x ULN.
  • Adequate renal function with estimated creatinine clearance of ≥ 60 ml/min according to the Cockcroft-Gault formula, unless calculated to be < 60 ml/min or borderline in which case GFR should be formally measured; e.g., with EDTA scan.
  • ECOG Performance Status of 0, 1, 2, or 3 10. Study treatment both planned and able to start within 14 days of randomisation. Willing and able to comply with all study requirements, including treatment, timing and nature of required assessments. Able to provide signed, written informed consent

Exclusion Criteria:

  • Other primary malignancy (EXCEPT adequately treated non-melanomatous carcinoma of the skin, germ cell tumour, or other malignancy treated at least 5 years previously with no evidence of recurrence).
  • Previous chemotherapy or radiotherapy, except:
    • pure seminoma relapsing after adjuvant radiotherapy or adjuvant chemotherapy with 1-2 doses of single agent carboplatin;
    • non-seminoma and poor prognosis by IGCCC criteria or stage IV malignant ovarian germ cell tumour in the rare case where low-dose induction chemotherapy is given prior to registration because patient is not fit enough to receive protocol chemotherapy (e.g., organ failure, vena cava obstruction, overwhelming burden of disease). Acceptable regimens include cisplatin 20 mg/m 2 days 1-2 and etoposide 100 mg/m 2 days 1-2; carboplatin AUC 3 days 1-2 and etoposide 100 mg/m 2 days 1-2; or baby-BOP.43 Patients must meet all other inclusion and exclusion criteria at the time of registration;
    • Participants who need to start therapy urgently prior to completing study-specific baseline investigations may commence study chemotherapy prior to registration and randomisation. Such patients must be discussed with the coordinating centre prior to registration, and must be registered within 10 days of commencing study chemotherapy.
  • Significant cardiac disease resulting in inability to tolerate IV fluid hydration for cisplatin.
  • Significant co-morbid respiratory disease that contraindicates the use of bleomycin.
  • Peripheral neuropathy ≥ grade 2 or clinically significant sensorineural hearing loss or tinnitus.
  • Concurrent illness, including severe infection that may jeopardize the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety.
  • Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration.
  • Known allergy or hypersensitivity to any of the study drugs.
  • Presence of any psychological, familial, sociological or geographical condition that in the opinion of the investigator would hamper compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse.

Eligibility last updated 9/7/21. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Carola Arndt, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20491469

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