Kidney Cancer Clinical Trial
ODSH + ICE Chemotherapy in Pediatric Solid Tumors
Summary
This study will be with pediatric patients who have refractory/recurrent solid tumors. They will receive standard chemotherapy (ICE) and we are investigating if the addition of a new drug, ODSH, will help to increase the time of their platelet recovery after ICE chemotherapy.The purpose of this study is to evaluate the safety and tolerability of ODSH in pediatric patients receiving "ICE" chemotherapy.
Eligibility Criteria
Inclusion Criteria:
Recurrent or refractory solid tumors. This may include, but is not limited to, osteosarcoma, chondrosarcoma, Ewing's sarcoma, Wilm's Tumor, medulloblastoma, neuroblastoma, hepatoblastoma, rhabdomyosarcoma, retinoblastoma, and primitive neuroectodermal tumors. Histologic proof malignancy must have been available at the time of initial diagnosis.
Age: 1-21
Patients must have received standard first-line chemotherapy or other appropriate standard first line therapy for their malignancy.
Patients must have radiologic or histologic evidence of recurrence
Patients must have fully recovered from the toxic effects of the prior chemotherapy and must have an ANC >1000/μL and a platelet count >100,000/μL
Performance status > 60 from Lansky (age 1 to 16) or Karnofsky (age > 16)
Adequate hepatic and renal function (AST, ALT, bilirubin and creatinine < 2.5 x upper normal limit).
Parent or guardian able to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelines.
Exclusion Criteria:
Patients who, in the investigator's opinion, have extensive bone marrow involvement with tumor
Presence of significant active infection or uncontrolled bleeding
Renal insufficiency, which, in the opinion of the investigator, might adversely affect schedule and dose of therapy ICE chemotherapy. patients with creatinine levels ≥2 mg/dl are not eligible
Pre-existing liver disease , other than liver metastasis
Use of recreational drugs within the prior month
Known history of positive hepatitis B surface antigens or HCV antibodies
Known history of positive test for HIV antibodies
Patients receiving any form of anticoagulant therapy
Presence of a known bleeding disorder or coagulation abnormality
Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to study entry
Pregnant or breast-feeding patients
Patient with childbearing potential not using adequate contraception
Hemorrhage risk that requires maintenance of platelet counts at 50,000 or higher.
Psychiatric or neurologic conditions that could compromise patient safety or compliance, or interfere with the ability of the patient or family to give proper informed consent.
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There is 1 Location for this study
Valhalla New York, 10595, United States
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