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ODSH + ICE Chemotherapy in Pediatric Solid Tumors

Primary Purpose

Recurrent Solid Tumor, Refractory Solid Tumor, Sarcoma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ODSH
Sponsored by
New York Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Solid Tumor focused on measuring ICE, ODSH, platelet recovery, recurrent solid tumor

Eligibility Criteria

1 Year - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New York Medical College

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ODSH and ICE Chemotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 12, 2014
Last Updated
December 20, 2017
Sponsor
New York Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT02164097
Brief Title
ODSH + ICE Chemotherapy in Pediatric Solid Tumors
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
low accrual
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York Medical College

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Solid Tumor, Refractory Solid Tumor, Sarcoma, Wilms' Tumor, Neuroblastoma
Keywords
ICE, ODSH, platelet recovery, recurrent solid tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ODSH and ICE Chemotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ODSH
Other Intervention Name(s)
2-O, 3-O Desulfated Heparin
Primary Outcome Measure Information:
Title
To determine if ODSH is safe in pediatric patients
Description
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.
Time Frame
60 days following last dose of ODSH
Secondary Outcome Measure Information:
Title
To see if ODSH has a positive effect on platelet recovery
Description
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.
Time Frame
60 days after last dose of ODSH

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Cairo, MD
Organizational Affiliation
New York Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States

12. IPD Sharing Statement

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ODSH + ICE Chemotherapy in Pediatric Solid Tumors

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