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Observation and/or Combination Chemotherapy After Surgery or Biopsy in Treating Young Patients With Extracranial Germ Cell Tumors

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Childhood Germ Cell Tumor; Extragonadal Germ Cell Tumor; Ovarian Cancer

Intervention: bleomycin sulfate (Biological); carboplatin (Drug); cisplatin (Drug); etoposide (Drug); ifosfamide (Drug); vinblastine sulfate (Drug); adjuvant therapy (Procedure); conventional surgery (Procedure)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Children's Cancer and Leukaemia Group

Official(s) and/or principal investigator(s):
Juliet Hale, MD, Principal Investigator, Affiliation: Sir James Spence Institute of Child Health at Royal Victoria Infirmary

Summary

RATIONALE: Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. Drugs used in chemotherapy 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 combination chemotherapy after surgery may kill any remaining tumor cells. PURPOSE: This phase III trial is studying how well observation and/or combination chemotherapy works after surgery or biopsy in treating young patients with extracranial germ cell tumors.

Clinical Details

Official title: Protocol for the Treatment of Extracranial Germ Cell Tumours in Children and Adolescents (GC III)

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

Primary outcome:

Event-free survival

Continuation of treatment

Development of common and follow-up strategies

Registration of all cases of mature and immature teratoma

Detailed description: OBJECTIVES:

- Stratify and reduce treatment for pediatric patients with extracranial germ cell tumors

while maintaining event-free survival.

- Treat newly diagnosed patients with extracranial germ cell tumors requiring

chemotherapy with a carboplatin-based strategy.

- Develop a common strategy for the treatment of patients with recurrent or progressive

extracranial germ cell tumors.

- Register all cases of mature and immature teratoma.

- Develop a common strategy for the management of immature and mature teratoma, including

follow-up strategies to permit early detection of yolk sac recurrence. OUTLINE: This is a multicenter study. Patients who have not had prior biopsy or surgical resection undergo biopsy (if feasible) or surgical resection. Patients with mature or immature teratoma undergo observation. These patients who relapse (i. e., tumor regrowth) may undergo further surgical resection unless tumor markers are significantly elevated. If the tumor markers are significantly elevated, these patients proceed to JEB chemotherapy according to risk group. Patients with all other malignant germ cell tumors are assigned to 1 of 3 treatment groups according to risk.

- Low-risk group: Patients with normal tumor markers undergo observation. Patients with

rising tumor markers only AND no imageable tumor proceed to treatment as in the intermediate-risk group. Patients with rising tumor markers AND/OR imageable tumor are considered to have relapsed and proceed to treatment as in the intermediate- or high-risk group.

- Intermediate-risk group: Patients receive JEB chemotherapy comprising etoposide IV over

4 hours on days 1-3, carboplatin IV over 1 hour on day 2, and bleomycin IV over 30 minutes on day 3. Treatment repeats every 21 days for 4 courses. Patients with residual tumors after completion of chemotherapy may undergo second-look surgery.

- High-risk group: Patients receive JEB chemotherapy as in the intermediate-risk group

for 6 courses. Patients with residual tumors after completion of chemotherapy may undergo second-look surgery.

- Relapse therapy: Patients in the intermediate- or high-risk group who relapse after

completion of JEB chemotherapy receive vinblastine IV on days 1 and 2, ifosfamide IV over 1 hour on days 1-5, and cisplatin IV on days 1-5. Treatment repeats every 21 days for 6 courses. PROJECTED ACCRUAL: A total of 105 patients will be accrued for this study.

Eligibility

Minimum age: N/A. Maximum age: 17 Years. Gender(s): Both.

Criteria:

DISEASE CHARACTERISTICS:

- Histologically* proven extracranial malignant germ cell tumor (GCT), including

mature/immature teratoma, with or without elevated alpha-fetoprotein (AFP) or human chorionic gonadotropin (HCG) levels

- Newly diagnosed disease

- Patients with relapsed or progressive extracranial malignant GCT allowed if

previously treated with carboplatin, etoposide, and bleomycin (JEB) chemotherapy

- Patients relapsing following JEB are eligible for the study relapse

strategy NOTE: *Patients with unequivocally raised AFP/HCG whose risk of biopsy is felt to be high can be diagnosed by clinical grounds, imaging, and markers

- No intracranial GCTs

PATIENT CHARACTERISTICS:

- Neutrophil count ≥ 1,000/mm^3

- Platelet count ≥ 100,000/mm^3

- Bilirubin ≤ 2 times upper limit of normal (ULN)

- ALT ≤ 3 times ULN

- Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior chemotherapy other than JEB

Locations and Contacts

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

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

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

Addenbrooke's Hospital, 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, London, England WC1N 3JH, United Kingdom

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

Royal Manchester Children's Hospital, Manchester, England M27 4HA, United Kingdom

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

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

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

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

Royal Marsden - 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: May 2005
Last updated: September 16, 2013

Page last updated: August 23, 2015

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