Recurrent Solid Tumor, Refractory Solid Tumor, Sarcoma, Wilms' Tumor, Neuroblastoma
Conditions
Keywords
ICE, ODSH, platelet recovery, recurrent solid tumor
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.
Interventions
DRUGODSH
Sponsors
New York Medical College
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 21 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine if ODSH is safe in pediatric patients | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To see if ODSH has a positive effect on platelet recovery | 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. |
Countries
United States
Outcome results
None listed