Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Layout table for study information
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Show Show 22 study locations
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Investigators
Layout table for investigator information
Study Chair: A. Oakhill, MD Bristol Royal Hospital for Children
OverallOfficial: Michael Sokal Nottingham City Hospital
OverallOfficial: P. Gornall, MD Birmingham Children’s Hospital
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00276718    
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:
Layout table for MeSH terms
Neoplasms, Germ Cell and Embryonal
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Nervous System Diseases
Carboplatin
Etoposide
Bleomycin
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic