ODSH + ICE Chemotherapy in Pediatric Solid Tumors

NCT ID: NCT02164097

Last Updated: 2017-12-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-12-31

Brief 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.

Conditions

Recurrent Solid Tumor; Refractory Solid Tumor; Sarcoma; Wilms' Tumor; Neuroblastoma

Keywords

ICE; ODSH; platelet recovery; recurrent solid tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ODSH and ICE Chemotherapy

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.

Group Type: EXPERIMENTAL

ODSH

Intervention Type: DRUG

Interventions

ODSH

Intervention Type: DRUG

Other Intervention Names

2-O, 3-O Desulfated Heparin

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York Medical College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mitchell Cairo, MD

Role: PRINCIPAL_INVESTIGATOR

New York Medical College

Locations

New York Medical College

Valhalla, New York, United States

Countries

United States

Other Identifiers

NYMC-165

Identifier Type: -

Identifier Source: org_study_id