ODSH + ICE Chemotherapy in Pediatric Solid Tumors

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study to Evaluate the Safety and Preliminary Evidence of an Effect of ODSH (2-O, 3-O Desulfated Heparin) in Accelerating Platelet Recovery in Pediatric Patients With a Recurrent Solid Tumor Receiving ICE Chemotherapy

Conditions
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Recurrent Solid Tumor, Refractory Solid Tumor, Sarcoma, Wilms' Tumor, Neuroblastoma

Intervention / Treatment
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* Drug: ODSH


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ODSH and ICE Chemotherapy<br>Patients will receive standard doses of ICE Chemotherapy: Ifosfamide 1800 mg/m2 mixed with Mesna 360 mg/m2 IV over 2 hours on days 1, 2, 3, 4, and 5 Carboplatin 400 mg/m2 IV over 1 hour on days 1 and 2 Etoposide 100 mg/m2 IV over 1 hour on days 1, 2, 3, 4, and 5 ODSH will be administered as a 4 mg/kg bolus 30 minutes after the first ifosfamide dose followed immediately by a continuous intravenous ODSH infusion of 0.25 mg/kg/hour for five consecutive days, on days 1-5, for a total of 120 hours of continuous ODSH infusion. | Drug: ODSH<br> <br> * Other names: 2-O, 3-O Desulfated Heparin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if ODSH is safe in pediatric patients | All patients will be followed for 60 days after the last dose of ODSH in a treatment cycle in which ODSH is administered. All serious adverse events related to ODSH will be monitored. | 60 days following last dose of ODSH | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To see if ODSH has a positive effect on platelet recovery | Platelet counts will be monitored to determine when the platelet count remained > 100,000 after nadir for two consecutive days in the absence of a prior platelet transfusion within the previous 48 hours in pediatric patients receiving ICE chemotherapy. | 60 days after last dose of ODSH | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICE, ODSH, platelet recovery, recurrent solid tumor