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

Primary Purpose

Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
bleomycin sulfate
carboplatin
etoposide
conventional surgery
Sponsored by
Children's Cancer and Leukaemia Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring 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

Eligibility Criteria

undefined - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Our Lady's Hospital for Sick Children
  • Birmingham Children's Hospital
  • Institute of Child Health at University of Bristol
  • Bristol Royal Hospital for Children
  • Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
  • Leeds Cancer Centre at St. James's University Hospital
  • Leicester Royal Infirmary
  • Royal Liverpool Children's Hospital, Alder Hey
  • Royal London Hospital
  • Great Ormond Street Hospital for Children NHS Trust
  • Central Manchester and Manchester Children's University Hospitals NHS Trust
  • Sir James Spence Institute of Child Health
  • Queen's Medical Centre
  • Oxford Radcliffe Hospital
  • Children's Hospital - Sheffield
  • Southampton General Hospital
  • Royal Marsden NHS Foundation Trust - Surrey
  • Royal Belfast Hospital for Sick Children
  • Royal Aberdeen Children's Hospital
  • Royal Hospital for Sick Children
  • Royal Hospital for Sick Children
  • Childrens Hospital for Wales

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 12, 2006
Last Updated
September 16, 2013
Sponsor
Children's Cancer and Leukaemia Group
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1. Study Identification

Unique Protocol Identification Number
NCT00276718
Brief Title
Etoposide, Carboplatin, and Bleomycin in Treating Young Patients Undergoing Surgery For Malignant Germ Cell Tumors
Official Title
Germ Cell Tumour Study II
Study Type
Interventional

2. Study Status

Record Verification Date
February 2006
Overall Recruitment Status
Unknown status
Study Start Date
April 1989 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Children's Cancer and Leukaemia Group

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Ovarian Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
bleomycin sulfate
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Procedure
Intervention Name(s)
conventional surgery

10. Eligibility

Sex
All
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A. Oakhill, MD
Organizational Affiliation
Bristol Royal Hospital for Children
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Michael Sokal
Organizational Affiliation
Nottingham City Hospital
First Name & Middle Initial & Last Name & Degree
P. Gornall, MD
Organizational Affiliation
Birmingham Children's Hospital
Facility Information:
Facility Name
Our Lady's Hospital for Sick Children
City
Dublin
ZIP/Postal Code
12
Country
Ireland
Facility Name
Birmingham Children's Hospital
City
Birmingham
State/Province
England
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Facility Name
Institute of Child Health at University of Bristol
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8AE
Country
United Kingdom
Facility Name
Bristol Royal Hospital for Children
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8BJ
Country
United Kingdom
Facility Name
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Royal Liverpool Children's Hospital, Alder Hey
City
Liverpool
State/Province
England
ZIP/Postal Code
L12 2AP
Country
United Kingdom
Facility Name
Royal London Hospital
City
London
State/Province
England
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Great Ormond Street Hospital for Children NHS Trust
City
London
State/Province
England
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Facility Name
Central Manchester and Manchester Children's University Hospitals NHS Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M27 4HA
Country
United Kingdom
Facility Name
Sir James Spence Institute of Child Health
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Queen's Medical Centre
City
Nottingham
State/Province
England
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Oxford Radcliffe Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
0X3 9DU
Country
United Kingdom
Facility Name
Children's Hospital - Sheffield
City
Sheffield
State/Province
England
ZIP/Postal Code
S10 2TH
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Royal Belfast Hospital for Sick Children
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT12 6BE
Country
United Kingdom
Facility Name
Royal Aberdeen Children's Hospital
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZG
Country
United Kingdom
Facility Name
Royal Hospital for Sick Children
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH9 1LF
Country
United Kingdom
Facility Name
Royal Hospital for Sick Children
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G3 8SJ
Country
United Kingdom
Facility Name
Childrens Hospital for Wales
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XW
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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