Etoposide, Carboplatin, and Bleomycin in Treating Young Patients Undergoing Surgery For Malignant Germ Cell Tumors

Not Applicable

• Conditions: Brain and Central Nervous System Tumors; Childhood Germ Cell Tumor; Extragonadal Germ Cell Tumor; Ovarian Cancer

• Registration Number: NCT00276718
• Lead Sponsor: Children's Cancer and Leukaemia Group

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as etoposide, carboplatin, and bleomycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy drugs before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving combination chemotherapy after surgery may kill any tumor cells that remain.

PURPOSE: This clinical trial is studying how well giving etoposide, carboplatin, and bleomycin works in treating young patients undergoing surgery for malignant germ cell tumors.

Detailed Description

OBJECTIVES:

* Determine the toxic effects of etoposide, carboplatin, and bleomycin in young patients with malignant germ cell tumors.

OUTLINE: Patients are assigned to one of two treatment arms based on their tumor type (testicular vs ovarian, uterine, vaginal, sacrococcygeal, retroperitoneal, or thoracic).

* Group 1 (testicular tumors): Patients undergo radical orchiectomy. Patients with stage I tumors and alpha-fetoprotein (AFP) decreasing at the expected rate receive no further treatment unless there is a subsequent rise in the AFP or a clinical recurrence. Patients with stage II-IV tumors receive etoposide IV over 1 hour on days 1-3, carboplatin IV over 1 hour on day 2, and bleomycin IV over 15 minutes on day 3. Treatment repeats every 21- 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Residual teratoma may be removed, if indicated, after completion of chemotherapy.

* Group 2 (ovarian, uterine, vaginal, sacrococcygeal, retroperitoneal, or thoracic germ cell tumors): Patients undergo surgical removal or biopsy of the tumor. Patients then receive etoposide, carboplatin, and bleomycin as above. Patients may then undergo further surgery at the discretion of the principal investigator.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 1989-04
• Study First Submitted: 2006-01-12
• Study First Submitted QC: 2006-01-12
• Study First Posted: 2006-01-13
• Status Verified: 2006-02
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (21)

Our Lady's Hospital for Sick Children; 🇮🇪 Dublin, Ireland

Great Ormond Street Hospital for Children NHS Trust; 🇬🇧 London, England, United Kingdom

Birmingham Children's Hospital; 🇬🇧 Birmingham, England, United Kingdom

Royal Marsden NHS Foundation Trust - Surrey; 🇬🇧 Sutton, England, United Kingdom

Royal Belfast Hospital for Sick Children; 🇬🇧 Belfast, Northern Ireland, United Kingdom

Institute of Child Health at University of Bristol; 🇬🇧 Bristol, England, United Kingdom

Bristol Royal Hospital for Children; 🇬🇧 Bristol, England, United Kingdom

Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust; 🇬🇧 Cambridge, England, United Kingdom

Royal Liverpool Children's Hospital, Alder Hey; 🇬🇧 Liverpool, England, United Kingdom

Leicester Royal Infirmary; 🇬🇧 Leicester, England, United Kingdom

Royal London Hospital; 🇬🇧 London, England, United Kingdom

Queen's Medical Centre; 🇬🇧 Nottingham, England, United Kingdom

Central Manchester and Manchester Children's University Hospitals NHS Trust; 🇬🇧 Manchester, England, United Kingdom

Sir James Spence Institute of Child Health; 🇬🇧 Newcastle-Upon-Tyne, England, United Kingdom

Southampton General Hospital; 🇬🇧 Southampton, England, United Kingdom

Oxford Radcliffe Hospital; 🇬🇧 Oxford, England, United Kingdom

Children's Hospital - Sheffield; 🇬🇧 Sheffield, England, United Kingdom

Royal Hospital for Sick Children; 🇬🇧 Glasgow, Scotland, United Kingdom

Royal Aberdeen Children's Hospital; 🇬🇧 Aberdeen, Scotland, United Kingdom

Childrens Hospital for Wales; 🇬🇧 Cardiff, Wales, United Kingdom

Leeds Cancer Centre at St. James's University Hospital; 🇬🇧 Leeds, England, United Kingdom