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

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Brain and Central Nervous System Tumors; Childhood Germ Cell Tumor; Extragonadal Germ Cell Tumor; Ovarian Cancer

Intervention: bleomycin sulfate (Biological); carboplatin (Drug); etoposide (Drug); conventional surgery (Procedure)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Children's Cancer and Leukaemia Group

Official(s) and/or principal investigator(s):
A. Oakhill, MD, Study Chair, Affiliation: Bristol Royal Hospital for Children
Michael Sokal, Affiliation: Nottingham City Hospital
P. Gornall, MD, Affiliation: Birmingham Children's Hospital

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.

Clinical Details

Official title: Germ Cell Tumour Study II

Study design: Masking: Open Label, Primary Purpose: Treatment

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.

Eligibility

Minimum age: N/A. Maximum age: 15 Years. Gender(s): Both.

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

Locations and Contacts

Our Lady's Hospital for Sick Children, Dublin 12, Ireland

Birmingham Children's Hospital, Birmingham, England B4 6NH, United Kingdom

Bristol Royal Hospital for Children, Bristol, England BS2 8BJ, United Kingdom

Institute of Child Health at University of Bristol, Bristol, England BS2 8AE, United Kingdom

Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust, Cambridge, England CB2 2QQ, United Kingdom

Leeds Cancer Centre at St. James's University Hospital, Leeds, England LS9 7TF, United Kingdom

Leicester Royal Infirmary, Leicester, England LE1 5WW, United Kingdom

Royal Liverpool Children's Hospital, Alder Hey, Liverpool, England L12 2AP, United Kingdom

Great Ormond Street Hospital for Children NHS Trust, London, England WC1N 3JH, United Kingdom

Royal London Hospital, London, England E1 1BB, United Kingdom

Central Manchester and Manchester Children's University Hospitals NHS Trust, Manchester, England M27 4HA, United Kingdom

Sir James Spence Institute of Child Health, Newcastle-Upon-Tyne, England NE1 4LP, United Kingdom

Queen's Medical Centre, Nottingham, England NG7 2UH, United Kingdom

Oxford Radcliffe Hospital, Oxford, England 0X3 9DU, United Kingdom

Children's Hospital - Sheffield, Sheffield, England S10 2TH, United Kingdom

Southampton General Hospital, Southampton, England SO16 6YD, United Kingdom

Royal Marsden NHS Foundation Trust - Surrey, Sutton, England SM2 5PT, United Kingdom

Royal Belfast Hospital for Sick Children, Belfast, Northern Ireland BT12 6BE, United Kingdom

Royal Aberdeen Children's Hospital, Aberdeen, Scotland AB25 2ZG, United Kingdom

Royal Hospital for Sick Children, Edinburgh, Scotland EH9 1LF, United Kingdom

Royal Hospital for Sick Children, Glasgow, Scotland G3 8SJ, United Kingdom

Childrens Hospital for Wales, Cardiff, Wales CF14 4XW, United Kingdom

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: April 1989
Last updated: September 16, 2013

Page last updated: August 20, 2015

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