Clinical trial · Interventional
Surgery and/or Chemotherapy in Treating Children With Infantile, Congenital, or Childhood Fibrosarcoma
A Pilot Phase II Study for Children With Infantile Fibrosarcoma
NCT00072280CI-TRIAL-00015726terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to poor accrual
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed. Giving combination chemotherapy after surgery may kill any remaining tumor cells. PURPOSE: This phase II trial is studying how well surgery and/or combination chemotherapy work in treating children with fibrosarcoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Surgery | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| dactinomycin | Biological | Dactinomycin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| Filgrastim | Biological | Filgrastim | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| MESNA (mercaptoethane sulfonate) | Biological | — | UNRESOLVED |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chemotherapy plus possible surgery
- description
- Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery. (See Interventions section for drug dosage and administration details.)
- interventionNames
- Biological: dactinomycin
- Drug: cyclophosphamide
- Drug: etoposide
- Drug: ifosfamide
- Drug: vincristine sulfate
- Procedure: Conventional Surgery
- Biological: MESNA (mercaptoethane sulfonate)
- Biological: Filgrastim
- type
- EXPERIMENTAL
- label
- Surgery only
- description
- Comprised of patients with initially resectable disease lesions. All patients undergo Conventional Surgery. Those with a result of clear or microscopically positive margins remain on study in this arm, for observation with no further intervention.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 2 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed infantile, congenital, or pediatric fibrosarcoma
* Initial biopsy or surgery performed within the past 35 days
* No evidence of distant metastases
* Available tissue for central review
PATIENT CHARACTERISTICS:
Age
* Under 2 at diagnosis
Performance status
* Zubrod Score (ECOG)
Life expectancy
* At least 8 weeks
Hematopoietic
* Absolute neutrophil count at least 1,000/mm\^3
* Platelet count at least 100,000/mm\^3\*
* Hemoglobin at least 10.0 g/dL\* NOTE: \*Transfusions allowed
Hepatic
* Total bilirubin no greater than 1.5 times upper limit of normal (ULN) (patients over 4 weeks of age)
* Patients under 4 weeks of age with an indirect hyperbilirubinemia are eligible, provided the following criteria are met:
* At least 2 bilirubin values at separate timepoints show a decrease in measurement
* Direct bilirubin is no greater than 20% of the total bilirubin
* Direct bilirubin no greater than 1.5 times ULN
* Alanine Aminotransferase (ALT) less than 2.5 times ULN
Renal
* Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
PRIOR/CONCURRENT THERAPY:
Biologic therapy
* No concurrent sargramostim (GM-CSF)
Chemotherapy
* No prior chemotherapy
* No other concurrent anticancer chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No prior or concurrent radiotherapy except emergent radiotherapy for impending tracheal compression
Surgery
* See Disease CharacteristicsReferences
Publications (0)
Data not yet available
No reference posted for this study.