Combination Chemotherapy in Treating Children With Newly Diagnosed Malignant Germ Cell Tumors

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effect on the body of combining cyclophosphamide with cisplatin, etoposide, and bleomycin in treating children who have newly diagnosed malignant germ cell tumors that are not in the brain and gonads.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bleomycin; Cisplatin; Cyclophosphamide; Etoposide; Etoposide phosphate; Lenograstim; Mesna; Sargramostim

Criteria

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

Age

• 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

Hematopoietic

• 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)

Hepatic

• Not specified

Renal

• 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)

Pulmonary

• 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%

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy

Surgery

• See Disease Characteristics