Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy Plus Amifostine in Treating Children With Malignant Germ Cell Tumors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Supportive care, Treatment	Closed	Under 15 at time of diagnosis	NCI	POG-9749 NCT00003811, P9749

Objectives

I.  Evaluate the early efficacy and toxicity profile of high-dose cisplatin, 
etoposide, bleomycin, and amifostine in children with newly diagnosed, 
high-risk malignant, extragonadal germ cell tumors.

II.  Determine whether the use of amifostine can reduce the hematologic and 
nonhematologic toxic effects of this combination chemotherapy in these 
patients when compared to similar patients treated on POG-9049/CCG-8881 with 
the same combination chemotherapy.

III.  Determine the response rate of patients treated with this regimen.

Entry Criteria

Disease Characteristics:

Histologically confirmed, newly diagnosed, high-risk, extracranial germ cell
tumors including the following:
  Yolk sac carcinoma (endodermal sinus tumor)
  Embryonal carcinoma
  Choriocarcinoma
  Teratoma with mixed malignant elements (malignant teratoma)
OR
Malignant recurrence (stage III or IV) of previously resected stage I
extracranial, extragonadal tumor

High-risk disease defined as stage III or IV extragonadal tumors

Measurable disease by diagnostic imaging

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 No prior chemotherapy

Endocrine therapy:
 Not specified

Radiotherapy:
 No prior radiotherapy

Surgery:
 See Disease Characteristics

Patient Characteristics:

Age:
 Under 15 at time of diagnosis

Performance status:
 Not specified

Life expectancy:
 Not specified

Hematopoietic:
 Absolute neutrophil count greater than 750/mm3
 Platelet count greater than 75,000/mm3

Hepatic:
 Not specified   

Renal:
 Creatinine normal OR
 Glomerular filtration rate at least 50% of normal

Expected Enrollment

A total of 25 patients will be accrued for this study within 1.39 years.

Outline

Patients undergo surgical biopsy or resection.  

Patients then receive bleomycin IV over 10 minutes on day 1 and etoposide IV 
over 1 hour, amifostine IV over 15 minutes, and cisplatin IV over 1 hour on 
days 1-5.  Treatment repeats every 3-4 weeks for 4 courses in the absence of 
unacceptable toxicity or disease progression.

Patients who have no disease after 4 courses of chemotherapy receive no 
further treatment.  Patients who have residual disease undergo second-look 
surgery.  After surgery, patients who still have active tumor receive 2 
additional courses of chemotherapy.  Those patients who still have tumor after 
the 2 additional courses may have a third surgery.

Patients are followed every month for 6 months, every 2 months for 6 months, 
every 6 months for 1 year, and then annually thereafter until death.

Marina N, Chang KW, Malogolowkin M, et al.: Amifostine does not protect against the ototoxicity of high-dose cisplatin combined with etoposide and bleomycin in pediatric germ-cell tumors: a Children's Oncology Group study. Cancer 104 (4): 841-7, 2005.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Pediatric Oncology Group

Neyssa Marina, MD, Protocol chair		Ph: 650-723-5535 Email: neyssa.marina@stanford.edu

Registry Information
Official Title		High-Dose Cisplatin, Etoposide and Bleomycin (HD-PEB) Combined with Amifostine in Children with High-Risk Malignant Germ Cell Tumors - A POG Pilot Study
Trial Start Date		2000-04-28
Registered in ClinicalTrials.gov		NCT00003811
Date Submitted to PDQ		1999-03-05
Information Last Verified		2006-05-18
NCI Grant/Contract Number		CA30969

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