ODSH + ICE Chemotherapy in Pediatric Solid Tumors

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02164097
• Other study ID #: NYMC-165
• Status: Terminated
• Phase: Phase 1
• First received: June 12, 2014
• Last updated: December 20, 2017
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: December 2017
• Source: New York Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Neuroblastoma
• Recurrent Solid Tumor
• Refractory Solid Tumor
• Sarcoma
• Wilms Tumor
• Wilms' Tumor

Intervention

Drug:
• ODSH

Locations

Country	Name	City	State
United States	New York Medical College	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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