Cabozantinib S-malate in Treating Patients With Relapsed Osteosarcoma or Ewing Sarcoma (NCT02243605) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Cabozantinib S-malate in Treating Patients With Relapsed Osteosarcoma or Ewing Sarcoma
France90 participantsStarted 2014-12-19
Plain-language summary
This phase II trial studies how well cabozantinib s-malate works in treating patients with osteosarcoma or Ewing sarcoma that has grown or returned (come back) after a period of improvement. Cabozantinib s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may also prevent the growth of new blood vessels that tumors need to grow.
Who can participate
Age range12 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.
Inclusion Criteria:
* Young patient age between 12 - 15 could be included in only 6 centers (Bordeaux, Lyon, Villejuif, Lille, Marseille and Paris)
* Patients must have histologically confirmed diagnosis of osteosarcoma or Ewing sarcoma by central review, except if the diagnosis was already confirmed by the RRePS (Reseau de Reference en Pathologie des Sarcomes et des Tissus Mous et des Visceres) network
* Relapsed disease after standard chemotherapy
* Patients must have measurable disease (lesion in previously irradiated field could be considered as measurable if progressive at inclusion) defined as per RECIST v1.1 with at least one lesion that can be measured in at least one dimension (longest diameter to be recorded) as \>= 10 mm with spiral computed tomography (CT) scan
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
* Life expectancy of greater than 3 months
* Absolute neutrophil count \>= 1,500/mcL
* Lymphocyte count \> 1,000/mcL
* Platelets \>= 100,000/mcL
* Total bilirubin =\< 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.0 x institutional upper limit of normal
* Creatinine =\< 1.5 x ULN OR creatinine clearance \>= 50 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal (Cockcroft formula)
* Hemoglobin \>= 9 g/dL
* Serum albumin \>= 2.8 g/dL
* Lipase \< 2.0 x ULN …
What they're measuring
1
Non-progression at 6 Months - Osteosarcoma
Timeframe: At 6 months
2
Objective Response Within 6 Months of Treatment Onset - Osteosarcoma
Timeframe: Within 6 months of treatment onset
3
Objective Response Within 6 Months of Treatment Onset - Ewing Sarcoma