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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00276718
First received: January 12, 2006
Last updated: August 6, 2011
Last verified: February 2006

January 12, 2006
August 6, 2011
April 1989
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Complete list of historical versions of study NCT00276718 on ClinicalTrials.gov Archive Site
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Etoposide, Carboplatin, and Bleomycin in Treating Young Patients Undergoing Surgery For Malignant Germ Cell Tumors
Germ Cell Tumour Study II

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.

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.

Interventional
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Masking: Open Label
Primary Purpose: Treatment
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
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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
Both
up to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
Ireland,   United Kingdom
 
NCT00276718
CDR0000454749, CCLG-GC-1989-01, EU-20583
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Children's Cancer and Leukaemia Group
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Study Chair: A. Oakhill, MD Bristol Royal Hospital for Children
Investigator: Michael Sokal Nottingham City Hospital
Investigator: P. Gornall, MD Birmingham Children's Hospital
National Cancer Institute (NCI)
February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP