ODSH + ICE Chemotherapy in Pediatric Solid Tumors

December 20, 2017 updated by: New York Medical College

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Valhalla, New York, United States, 10595
        • New York Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 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.
Drug: ODSH
Other Names:
  • 2-O, 3-O Desulfated Heparin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To determine if ODSH is safe in pediatric patients
Time Frame: 60 days following last dose of ODSH
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To see if ODSH has a positive effect on platelet recovery
Time Frame: 60 days after last dose of ODSH
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
New York Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2014

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NYMC-165

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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