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Pilot Study of Cisplatin, Etoposide, Bleomycin and Escalating Dose Cyclophosphamide Therapy for Children With High Risk Malignant Germ Cell Tumors

21 Years
Not Enrolling
Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor

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Trial Information

Pilot Study of Cisplatin, Etoposide, Bleomycin and Escalating Dose Cyclophosphamide Therapy for Children With High Risk Malignant Germ Cell Tumors


- Determine the maximum tolerated dose and toxicity profile of cyclophosphamide in
combination with bleomycin, etoposide, and cisplatin in pediatric patients with newly
diagnosed high-risk extracranial, extragonadal malignant germ cell tumors.

- Determine the response rate in patients treated with this regimen.

OUTLINE: This is a pilot, multicenter, dose-escalation study of cyclophosphamide.

- Induction therapy: Patients receive bleomycin IV over 10-20 minutes on day 1, etoposide
IV over 1 hour and cisplatin IV over 4 hours on days 1-5, and cyclophosphamide IV over
1 hour on day 1. Patients also receive filgrastim (G-CSF) subcutaneously once daily
beginning on day 6 and continuing until blood counts recover. Treatment repeats every
21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 6 patients receive escalating doses of cyclophosphamide until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 6 patients experience dose-limiting toxicity.

Patients are evaluated after 4 courses of therapy. Patients with partial response or stable
disease undergo second-look surgery, receive 2 more courses of induction therapy, and are
then re-evaluated. Patients who do not achieve complete response (CR) after a total of 6
courses may undergo a third surgery. Patients who still have tumor that cannot be removed
are removed from study therapy. Patients who achieve a CR at anytime are followed.

Patients are followed monthly for 1 year, every 6 months for 1 year, and then annually for 3

PROJECTED ACCRUAL: A total of 6-18 patients will be accrued for this study within 1.3 years.

Inclusion Criteria


- Histologically confirmed newly diagnosed extracranial germ cell tumors, including 1
of the following types:

- Yolk sac carcinoma (endodermal sinus tumor)

- Embryonal carcinoma

- Choriocarcinoma

- Teratoma with mixed malignant elements (malignant teratoma)

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

- Must be enrolled on study within 21 days of diagnostic surgical procedure



- 21 and under (at original diagnosis)

Performance status

- ECOG 0-2

- Karnofsky 50-100% (in patients over 16 years of age)

- Lansky 50-100% (in patients 16 years of age and under)

Life expectancy

- At least 2 months


- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 100,000/mm^3 (transfusion independent)

- Hemoglobin at least 10.0 g/dL (transfusion allowed)


- Not specified


- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min OR

- Creatinine based on age as follows:

- No greater than 0.8 mg/dL (5 years and under)

- No greater than 1.0 mg/dL (6-10 years)

- No greater than 1.2 mg/dL (11-15 years)

- No greater than 1.5 mg/dL (over 15 years)


- FEV_1/FVC greater than 60% OR

- Children who are uncooperative must meet all of the following criteria:

- No dyspnea at rest

- No exercise intolerance

- Pulse oximetry greater than 94%


- Not pregnant or nursing

- Fertile patients must use effective contraception


Biologic therapy

- Not specified


- No prior chemotherapy

Endocrine therapy

- Not specified


- No prior radiotherapy


- See Disease Characteristics

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event Free Survival

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Marcio A. Malogolowkin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hospital Los Angeles


United States: Federal Government

Study ID:




Start Date:

July 2004

Completion Date:

Related Keywords:

  • Childhood Germ Cell Tumor
  • Extragonadal Germ Cell Tumor
  • childhood teratoma
  • childhood extragonadal germ cell tumor
  • Neoplasms, Germ Cell and Embryonal



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