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

Sponsor

Children's Cancer and Leukaemia Group (Other)

Overall Status

Unknown status

CT.gov ID

NCT00276718

Collaborator

(none)

100

Enrollment

Locations

4.5

Patients Per Site

Study Details

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.

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	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Germ Cell Tumour Study II

Study Start Date :

Apr 1, 1989

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 15 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Our Lady's Hospital for Sick Children	Dublin		Ireland	12
2	Birmingham Children's Hospital	Birmingham	England	United Kingdom	B4 6NH
3	Institute of Child Health at University of Bristol	Bristol	England	United Kingdom	BS2 8AE
4	Bristol Royal Hospital for Children	Bristol	England	United Kingdom	BS2 8BJ
5	Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust	Cambridge	England	United Kingdom	CB2 2QQ
6	Leeds Cancer Centre at St. James's University Hospital	Leeds	England	United Kingdom	LS9 7TF
7	Leicester Royal Infirmary	Leicester	England	United Kingdom	LE1 5WW
8	Royal Liverpool Children's Hospital, Alder Hey	Liverpool	England	United Kingdom	L12 2AP
9	Royal London Hospital	London	England	United Kingdom	E1 1BB
10	Great Ormond Street Hospital for Children NHS Trust	London	England	United Kingdom	WC1N 3JH
11	Central Manchester and Manchester Children's University Hospitals NHS Trust	Manchester	England	United Kingdom	M27 4HA
12	Sir James Spence Institute of Child Health	Newcastle-Upon-Tyne	England	United Kingdom	NE1 4LP
13	Queen's Medical Centre	Nottingham	England	United Kingdom	NG7 2UH
14	Oxford Radcliffe Hospital	Oxford	England	United Kingdom	0X3 9DU
15	Children's Hospital - Sheffield	Sheffield	England	United Kingdom	S10 2TH
16	Southampton General Hospital	Southampton	England	United Kingdom	SO16 6YD
17	Royal Marsden NHS Foundation Trust - Surrey	Sutton	England	United Kingdom	SM2 5PT
18	Royal Belfast Hospital for Sick Children	Belfast	Northern Ireland	United Kingdom	BT12 6BE
19	Royal Aberdeen Children's Hospital	Aberdeen	Scotland	United Kingdom	AB25 2ZG
20	Royal Hospital for Sick Children	Edinburgh	Scotland	United Kingdom	EH9 1LF
21	Royal Hospital for Sick Children	Glasgow	Scotland	United Kingdom	G3 8SJ
22	Childrens Hospital for Wales	Cardiff	Wales	United Kingdom	CF14 4XW