Clinical trial · Interventional
Vinblastine, Celecoxib, and Combination Chemotherapy in Treating Patients With Newly-Diagnosed Metastatic Ewing's Sarcoma Family of Tumors
A Pilot Study of Low-Dose Antiangiogenic Chemotherapy in Combination With Standard Multiagent Chemotherapy for Patients With Newly Diagnosed Metastatic 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)
RATIONALE: Drugs used in chemotherapy, such as vinblastine, work in different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of Ewing's sarcoma by stopping blood flow to the tumor. Combining more than one chemotherapy drug with celecoxib may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining low-dose vinblastine and celecoxib with standard regimens of combination chemotherapy in treating patients who have newly-diagnosed metastatic Ewing's sarcoma family of tumors.
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 (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| celecoxib | Drug | Celecoxib | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| Filgrastim | Drug | Filgrastim | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| MESNA | Drug | — | UNRESOLVED |
| radiation therapy |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combination chemotherapy
- description
- Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Refer to the Interventions section for dosages, method of delivery and frequency of administration.
- interventionNames
- Drug: celecoxib
- Drug: cyclophosphamide
- Drug: doxorubicin hydrochloride
- Drug: etoposide
- Drug: ifosfamide
- Drug: vinblastine sulfate
- Drug: vincristine sulfate
- Procedure: conventional surgery
- Radiation: radiation therapy
- Drug: MESNA
- Drug: Filgrastim
Primary outcomes (1)
- measure
- Occurrence of Severe Toxicity
- timeFrame
- The first two cycles (6 weeks) of protocol chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 50 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Newly diagnosed Ewing's sarcoma family of tumors of the bone or soft tissues * Paraspinal tumors of extra-dural origin and Askin's tumor of the chest wall are eligible * Metastatic disease, defined by the following criteria: * Lesions are discontinuous from the primary tumor, are not regional lymph nodes, and do not share a body cavity with the primary tumor * A single pulmonary or pleural nodule greater than 1 cm OR multiple nodules greater than 0.5 cm are considered evidence of pulmonary or pleural metastases (unless there is another clear medical explanation for these lesions) * Contralateral pleural effusions are considered metastatic disease * No CNS involvement PATIENT CHARACTERISTICS: Age * 50 and under (at diagnosis) Performance status * Lansky 50-100% (under 17 years of age) * Karnofsky 50-100% (age 17 and over) * Patients whose performance status is affected by a pathological fracture are allowed provided they are able to undergo treatment Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST or ALT less than 5 times ULN Renal * Creatinine adjusted according to age as follows\*: * No greater than 0.4 mg/dL (≤ 5 months) * No greater than 0.5 mg/dL (6 months -11 months) * No greater than 0.6 mg/dL (1 year-23 months) * No greater than 0.8 mg/dL (2 years-5 years) * No greater than 1.0 mg/dL (6 years-9 years) * No greater than 1.2 mg/dL (10 years-12 years) * No greater than 1.4 mg/dL (13 years and over \[female\]) * No greater than 1.5 mg/dL (13 years to 15 years \[male\]) * No greater than 1.7 mg/dL (16 years and over \[male\]) OR * Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min\* NOTE: \*Unless these values are related to renal insufficiency secondary to tumor involvement that is expected to improve once the tumor mass is smaller (e.g., pelvic mass causing obstructive hydronephrosis) Cardiovascular * Shortening fraction at least 27% by echocardiogram OR * Ejection fraction at least 50% by MUGA Other * Not pregnant or nursing * Fertile patients must use effective contraception * Body surface area at least 0.4 m\^2 * No allergy to sulfa * No aspirin hypersensitivity * No asthma triad (asthma with nasal polyps, and urticaria) * No other prior cancer, including nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * No prior bone marrow or stem cell transplantation Chemotherapy * No prior chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy Surgery * Not specified Other * No other concurrent nonsteroidal anti-inflammatory medications, including salicylates * No concurrent dexrazoxane unless approved by the study investigator
References
Publications (1)
- RESULTFelgenhauer JL, Nieder ML, Krailo MD, Bernstein ML, Henry DW, Malkin D, Baruchel S, Chuba PJ, Sailer SL, Brown K, Ranganathan S, Marina N. A pilot study of low-dose anti-angiogenic chemotherapy in combination with standard multiagent chemotherapy for patients with newly diagnosed metastatic Ewing sarcoma family of tumors: A Children's Oncology Group (COG) Phase II study NCT00061893. Pediatr Blood Cancer. 2013 Mar;60(3):409-14. doi: 10.1002/pbc.24328. Epub 2012 Oct 12. PMID 23065953