Recurrent Solid TumorPhase 1NCT02164097
ODSH + ICE Chemotherapy in Pediatric Solid Tumors
A Phase 1 study testing ODSH in people with Recurrent Solid Tumor and Refractory Solid Tumor, run by New York Medical College at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Recurrent Solid Tumor, Refractory Solid Tumor, Sarcoma
- What is being tested?
- ODSH
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- ODSH
- Keywords
- ICE, ODSH, platelet recovery, recurrent solid tumor
- Medical subject headings
- Sarcoma, Wilms Tumor, Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ODSHDrug
Also called 2-O, 3-O Desulfated Heparin
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: ODSH |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 days following last dose of ODSH
Secondary outcomes (1)
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.
Measured: 60 days after last dose of ODSH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mitchell Cairo, MD, Principal investigator, New York Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164097
- Sponsor's protocol ID
- NYMC-165
- Status last verified
- Dec 2017
- First submitted
- 12 Jun 2014
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02164097
- Acronym / sponsor ID
- NYMC-165
- Keywords
- ICE, ODSH, platelet recovery, recurrent solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 4 participants (actual)
- Lead sponsor
- New York Medical CollegeUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 16 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ODSH and ICE Chemotherapy | Experimental | Drug: ODSHPatients 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. |
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ODSHAlso: 2-O, 3-O Desulfated Heparin | Drug | ODSH and ICE Chemotherapy |
Primary outcome
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.
1 secondary outcome
To see if ODSH has a positive effect on platelet recovery
Time frame: 60 days after last dose of ODSH
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell Cairo, MD principal investigator
New York Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ODSH in people with Recurrent Solid Tumor and Refractory Solid Tumor, run by New York Medical College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: low accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if ODSH is safe in pediatric patients (time frame: 60 days following last dose of ODSH). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2017.