Clinical trial NCT00061893 (phase 2, status: completed)
Conditions: sarcoma
ICD codes: C96.A, C46.9, C96.22, C46.0, C46.2, C92.31, C92.32
Drugs: celecoxib, cyclophosphamide, doxorubicin hydrochloride, etoposide, ifosfamide, vinblastine sulfate, vincristine sulfate, mesna, filgrastim
SMILES: COC1=CC=C(C=C1)C(=O)CC(=O)C1=CC=C(C=C1)C(C)(C)C, ClCCN(CCCl)P1(=O)NCCCO1, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O, OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1, N[C@@H](CCCNC(N)=N)C(O)=O, CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1, CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1, OS(=O)(=O)CCS, N[C@@H](CCCNC(N)=N)C(O)=O
Eligibility criteria:

        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