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

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ClinicalTrials.gov Identifier: NCT00276718
Recruitment Status : Unknown
Verified February 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 13, 2006
Last Update Posted : September 17, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

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.


Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Childhood Germ Cell Tumor Extragonadal Germ Cell Tumor Ovarian Cancer Biological: bleomycin sulfate Drug: carboplatin Drug: etoposide Procedure: conventional surgery Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Germ Cell Tumour Study II
Study Start Date : April 1989






Information from the National Library of Medicine

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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven malignant germ cell tumors at all stages

    • Testicular tumors

      • Stage I - Confined to testes
      • Stage II - Confined to testes and retroperitoneal/abdominal lymph nodes
      • Stage III - Supradiaphragmatic nodal disease (mediastinal and/or supraclavicular)
      • Stage IV - Extralymphatic spread (liver, lung, bone, brain, skin, etc.)
    • Ovarian, uterine, vaginal, and sacrococcygeal tumors

      • Stage I - Confined to ovary/uterus/vagina/pre- and postsacral area
      • Stage II - Spread limited to the pelvis
      • Stage III - Spread limited to the abdomen (excluding liver)
      • Stage IV - Spread to liver or beyond the abdominal cavity
    • Abdominal, retroperitoneal, and thoracic primary tumors

      • Stage I - Confined to site of origin and resectable
      • Stage II - Local spread
      • Stage III - Extensive spread confined to one side of the diaphragm (excluding the liver)
      • Stage IV - Tumor spread to the liver, to both sides of the diaphragm, and/or to bones, bone marrow, brain, etc.
    • Intracranial germ cell tumor cases allowed even if an alternative protocol is being followed

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy

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): NCT00276718


Locations
Ireland
Our Lady's Hospital for Sick Children
Dublin, Ireland, 12
United Kingdom
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom, BS2 8AE
Bristol Royal Hospital for Children
Bristol, England, United Kingdom, BS2 8BJ
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, United Kingdom, CB2 2QQ
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom, L12 2AP
Royal London Hospital
London, England, United Kingdom, E1 1BB
Great Ormond Street Hospital for Children NHS Trust
London, England, United Kingdom, WC1N 3JH
Central Manchester and Manchester Children's University Hospitals NHS Trust
Manchester, England, United Kingdom, M27 4HA
Sir James Spence Institute of Child Health
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
Queen's Medical Centre
Nottingham, England, United Kingdom, NG7 2UH
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 9DU
Children's Hospital - Sheffield
Sheffield, England, United Kingdom, S10 2TH
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom, SM2 5PT
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom, BT12 6BE
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom, AB25 2ZG
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom, EH9 1LF
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom, G3 8SJ
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom, CF14 4XW
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Investigators
Study Chair: A. Oakhill, MD Bristol Royal Hospital for Children
OverallOfficial: Michael Sokal Nottingham City Hospital
OverallOfficial: P. Gornall, MD Birmingham Children's Hospital

ClinicalTrials.gov Identifier: NCT00276718     History of Changes
Other Study ID Numbers: CDR0000454749
CCLG-GC-1989-01
EU-20583
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: February 2006

Keywords provided by National Cancer Institute (NCI):
childhood malignant ovarian germ cell tumor
childhood malignant testicular germ cell tumor
childhood central nervous system germ cell tumor
childhood extragonadal germ cell tumor
childhood teratoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms, Germ Cell and Embryonal
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Nervous System Diseases
Etoposide phosphate
Carboplatin
Etoposide
Bleomycin
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic