Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Children's Oncology Group
Age
1–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age: Patients must be \> than 12 months and \< 18 years of age at the time of study enrollment.
Body Surface Area: Patients must have a BSA of ≥ 0.53 m2 at the time of study enrollment.
Diagnosis: Patients with refractory or recurrent solid tumors (excluding CNS tumors) and patients with unresectable translocation positive renal cell carcinoma (tRCC) are eligible. Patients must have had histologic verification of malignancy at original diagnosis or relapse.
The diagnosis of translocation morphology or TFE renal cell carcinoma is established by having characteristic morphology AND either a) strong nuclear TFE3 or TFEb staining on immunohistochemistry OR b) cytogenetic studies of the tumor demonstrating a TFE translocation OR c) fluorescent in situ hybridization (FISH) demonstrating a TFE translocation.
Disease Status: Patients must have either measurable or evaluable disease
Therapeutic Options: Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life.
Performance Level: Karnofsky ≥ 50% for patients \> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age . Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
Prior Therapy
Patients may have received bevacizumab, VEGF-Trap, or other VEGF blocking tyrosine kinase inhibitors, but may not have received axitinib.
Patients must have recovered from any VEGF blocking drug-related toxicity (e.g., proteinuria, hypertension).
All patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy.
Myelosuppressive chemotherapy: At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea).
Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair.
Biologic (anti-neoplastic agent): At least 7 days after the last dose of a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair.
Immunotherapy: At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines.
Monoclonal antibodies: At least 3 half-lives of the antibody after the last dose of a monoclonal antibody.
XRT: At least 14 days after local palliative XRT (small port); At least 150 days must have elapsed if prior TBI, craniospinal XRT or if ≥ 50% radiation of pelvis; At least 42 days must have elapsed if other substantial BM radiation.
Stem Cell Infusion without TBI: No evidence of active graft vs. host disease and at least 84 days must have elapsed after transplant or stem cell infusion.
* Platelet count ≥ 100,000/mm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
Adequate Renal Function Defined As:
Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 or
Adequate Liver Function Defined as:
Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x upper limit of normal (ULN) for age
SGPT (ALT) ≤ 110 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L.
SGOT (AST) ≤ 125 U/L. For the purpose of this study, the ULN for SGOT is 50 U/L.
Serum albumin ≥ 2 g/dL.
Adequate Cardiac Function Defined As:
Shortening fraction of ≥ 27% by echocardiogram, or Ejection fraction of ≥ 50% by gated radionuclide study.
Must not have a history of myocardial infarction, severe or unstable angina, or peripheral vascular disease.
Adequate Blood Pressure Control Defined As:
A blood pressure (BP) ≤ the 95th percentile for age, height, and gender
Adequate Coagulation Defined As:
No evidence of active bleeding
PT and PTT ≤ 1.2 x upper limit of normal (ULN)
INR ≤1.2
Adequate Pancreatic Function Defined as:
Lipase ≤ 1.5 x upper limit of normal (ULN).
Bleeding and Thrombosis:
You may not be if
Pregnancy or Breast-Feeding
Anti-GVHD agents post-transplant:
CYP3A4/5 Inhibitors:
CYP3A4/5 Inducers:
Patients must be able to swallow tablets whole.
History (within 180 days prior to study enrollment) of arterial thromboembolic events, including transient ischemic attack (TIA) or cerebrovascular accident (CVA).
History (within 180 days prior to study enrollment) of pulmonary embolism, DVT, or other venous thromboembolic event.
History of hemoptysis within 42 days prior to study enrollment.
Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within 28 days prior to enrollment.
Subcutaneous port placement or central line placement is not considered major surgery but must be placed at least 3 days prior to enrollment for external lines and at least 7 days prior to enrollment for subcutaneous port.
Core biopsy within 7 days prior to enrollment.
Fine needle aspirate or central line placement within 7 days prior to enrollment.
CNS disease:
Clareo Health | VEGF Receptor Tyrosine Kinase Inhibitor Axitinib in Children With Recurrent or Refractory Solid Tumors
