Clinical trial · Interventional
Combination Chemotherapy in Treating Children With Newly Diagnosed Malignant Germ Cell Tumors
Pilot Study of Cisplatin, Etoposide, Bleomycin and Escalating Dose Cyclophosphamide Therapy for Children With High Risk Malignant Germ Cell Tumors
NCT00066482CI-TRIAL-00012411completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Germ Cell Tumor | Childhood Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Extragonadal Germ Cell Tumor | Extragonadal Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bleomycin sulfate | Biological | Bleomycin | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| MESNA | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- combination chemotherapy
- description
- Induction therapy: bleomycin sulfate 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. MESNA \& 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. 6 patients receive escalating doses of cyclophosphamide until the maximum tolerated dose (MTD) is determined. Evaluated after 4 courses of therapy. Partial response or stable disease undergo second-look conventional surgery \& receive 2 more courses of induction therapy then re-evaluated. Those who do not achieve complete response (CR) after a total of 6 courses may undergo a third conventional surgery. Tumor that cannot be removed are removed from study therapy. Achievement of a CR at anytime are followed monthly for 1 year, every 6 months for 1 year, and then annually for 3 years.
- interventionNames
- Biological: bleomycin sulfate
- Biological: filgrastim
- Drug: cisplatin
- Drug: cyclophosphamide
- Drug: etoposide
- Procedure: conventional surgery
- Biological: MESNA
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.