Vinblastine, Celecoxib, and Combination Chemotherapy in Treating Patients With Newly-Diagnosed Me… (NCT00061893) | Clinical Trial Compass
CompletedPhase 2
Vinblastine, Celecoxib, and Combination Chemotherapy in Treating Patients With Newly-Diagnosed Metastatic Ewing's Sarcoma Family of Tumors
United States38 participantsStarted 2004-04
Plain-language summary
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.
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 grea…
What they're measuring
1
Occurrence of Severe Toxicity
Timeframe: The first two cycles (6 weeks) of protocol chemotherapy