ODSH + ICE Chemotherapy in Pediatric Solid Tumors

NCT02164097 | Terminated Phase 1

• 1 other identifier: NYMC-165
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To see if ODSH has a positive effect on platelet recovery

  60 days after last dose of ODSH

Study Arms (1)

ODSH and ICE Chemotherapy

EXPERIMENTAL

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

Interventions

ODSH DRUG

Also known as: 2-O, 3-O Desulfated Heparin

ODSH and ICE Chemotherapy

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York Medical College: lead

Study Sites (1)

New York Medical College

Valhalla, New York, 10595, United States

Location

MeSH Terms

Conditions

Sarcoma; Wilms Tumor; Neuroblastoma

Interventions

N-desulfated,2-O,3-O-desulfated heparin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Complex and Mixed; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Mitchell Cairo, MD

  New York Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2014
• First Posted: June 16, 2014
• Study Start: January 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 22, 2017

Record last verified: 2017-12

Locations

US (1)