Clinical trial NCT02164097: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Recurrent Solid Tumor
Refractory Solid Tumor
Sarcoma
Wilms' Tumor
Neuroblastoma
Keywords: ICE
ODSH
platelet recovery
recurrent solid tumor
Lead sponsor: New York Medical College
Sponsor class: OTHER
First posted: 2014-06-16
Enrollment: 4
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: To determine if ODSH is safe in pediatric patients
timeFrame: 60 days following last dose of ODSH
Secondary outcomes:
measure: To see if ODSH has a positive effect on platelet recovery
timeFrame: 60 days after last dose of ODSH
Other outcomes:
Locations:
city: Valhalla
country: United States
facility: New York Medical College
state: New York
Study officials:
affiliation: New York Medical College
name: Mitchell Cairo, MD
role: PRINCIPAL_INVESTIGATOR
References: