Clinical trial · Interventional
Two Regimens of Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed Localized Ewing Sarcoma Family of Tumors
A Pilot Study of Chemotherapy Intensification by Adding Vincristine, Topotecan and Cyclophosphamide to Standard Chemotherapy Agents With an Interval Compression Schedule in Newly Diagnosed Patients With Localized Ewing Sarcoma Family of Tumors
- 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)
This clinical trial is studying the side effects of combination chemotherapy and to see how well they work in treating patients with newly diagnosed localized Ewing sarcoma family of tumors. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving the drugs in different ways may kill more tumor cells.
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 |
|---|---|---|---|
| Ewing Sarcoma of Bone | Bone Ewing Sarcoma | ALIAS | 0.90 |
| Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | CURATED_BROADER | 0.78 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| radiation therapy | Other | — | UNRESOLVED |
| therapeutic conventional surgery | Other | — | UNRESOLVED |
| topotecan hydrochloride | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (combination chemotherapy)
- description
- See Detailed Description
- interventionNames
- Other: radiation therapy
- Other: therapeutic conventional surgery
- Drug: etoposide
- Drug: ifosfamide
- Drug: doxorubicin hydrochloride
- Drug: cyclophosphamide
- Drug: vincristine sulfate
- Drug: topotecan hydrochloride
- Biological: filgrastim
Primary outcomes (5)
- measure
- Incidence of Death
- timeFrame
- Length of protocol therapy (up to 37 weeks) plus 30 days
- description
- Incidence of death from complications of therapy while the patient is on protocol therapy or within one month of terminating protocol therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria:
* Diagnosis of extracranial Ewing sarcoma or peripheral primitive neuroectodermal tumor of bone or soft tissue:
* Newly diagnosed disease
* Disease confirmed by biopsy only with no attempt at complete or partial resection
* Unplanned excision allowed provided adequate imaging was obtained prior to surgery and incompletely resected disease is controlled by local therapy
* No esthesioneuroblastoma
* Localized disease, including any of the following sites:
* Chest wall tumors with ipsilateral pleural effusions, ipsilateral positive pleural fluid cytology, or ipsilateral pleural based secondary tumor nodules;
* No contralateral pleural effusions or pleural nodules
* Regional lymph nodes that are clinically suspicious or confirmed by biopsy
* No distant lymph node metastases
* Extra-dural tumors arising in the bony skull
* No tumors arising in the intra-dural soft tissue or the intra-dural region of the spine
* No evidence of metastatic disease, defined as any of the following:
* Lesions that are discontinuous from the primary tumor
* Lesions that are not regional lymph nodes
* Lesions that do not share a body cavity with the primary tumor
* No evidence by CT scan of metastatic lung disease, defined as any of the following:
* One pulmonary nodule \> 1 cm in diameter or more than one nodule \> 0.5 cm diameter
* Pulmonary nodules that are resected and are not found to be metastatic Ewing sarcoma are allowed
* Biopsy proven solitary nodules measuring 0.5 to 1.0 cm or multiple nodules measuring 0.3 to 0.5 cm
* Solitary nodules measuring \< 0.5 cm or multiple nodules measuring \< 0.3 cm are allowed unless biopsy proven to be metastatic (biopsy is not required)
* Karnofsky performance status (PS) 0-2 (\>= 16 years old) OR Lansky PS 0-2 (\< 16 years old)
* Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine based on age/gender as follows:
* 1 month to \< 6 months old (males and females 0.4 mg/dL)
* 6 months to \< 1 year old (males and females 0.5 mg/dL)
* 1 to \< 2 years old (males and females 0.6 mg/dL)
* 2 to \< 6 years old (males and females 0.8 mg/dL)
* 6 to \< 10 years old (males and females 1.0 mg/dL)
* 10 to \< 13 years old (males and females 1.2 mg/dL)
* 13 to \< 16 years old (males 1.5 mg/dL and females 1.4 mg/dL)
* \>= 16 years old (males 1.7 mg/dL and females 1.4 mg/dL)
* AST or ALT \< 2.5 times ULN for age
* Total bilirubin =\< 1.5 times upper limit of normal (ULN) for age
* Shortening fraction of \>= 27% by ECHO or ejection fraction of \>= 50% by radionuclide angiogram (MUGA)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior chemotherapy or radiotherapy
* No concurrent pegfilgrastim (Neulasta) or sargramostim (GM-CSF)
* No other concurrent cancer chemotherapy or immunomodulating agents, including steroids, unless used as an antiemeticReferences
Publications (0)
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