Tandem Peripheral Blood Stem Cell (PBSC) Rescue for High Risk Solid Tumors
Ewing's Sarcoma, Soft Tissue Sarcoma, Hepatoblastoma
About this trial
This is an interventional treatment trial for Ewing's Sarcoma focused on measuring wilm's tumor, stem cell transplantation, solid tumor
Eligibility Criteria
Inclusion Criteria: Malignant Diseases: Ewing's sarcoma/PNET: CR1 - Metastatic disease at diagnosis, tumor volume > 100 ml, pelvic bone primary CR2 - Locally recurrent disease Soft tissue sarcoma CR1 - Metastatic disease at diagnosis or locally advanced disease where local control is suboptimal (i.e., inability to provide radiation therapy due to extent of disease). CR2 - Locally recurrent disease (VGPR2 acceptable) Hepatoblastoma: VGPR1 - Patients with metastatic disease at diagnosis who have a persistently elevated alpha FP, or unresectable primary as a way of converting to resectable. CR2/VGPR2 Hodgkin's Disease: VGPR1 - Progression on primary therapy/Refractory disease CR2/VGPR2 Germ Cell Tumor: CR2/VGPR2 - recurrent disease Wilms Tumor: CR2/VGPR2 - recurrent disease IRB approved signed written informed consent by patient and/or their legally authorized guardian. Patients 21 years of age or younger at initial diagnosis, with older patients considered individually for primary pediatric disease diagnosis. Adequate central venous access (double lumen CVL or 2 single lumen PCVC). Adequate PBSC harvests with a minimum of 2.0 x 108 MNC/kg available for each PBSC rescue. Organ Function: Platelets > 50,000/ml SGOT < 10 x upper limits of normal Creatinine < 1.5 x normal baseline Normal cardiac function in accordance with institutional policies Normal pulmonary function in accordance with institutional policies. Physiologic status: No active infections Adequate performance status as measured by Karnofsky (> 70%) or Lansky scale (> 60%) as appropriate for age. Bone Marrow Status No evidence of morphologic involvement with tumor at the time of transplant Off Study Criteria: Severe toxicity. Contact the Study Coordinator immediately and complete Adverse Reaction Form. Disease progression or relapse prior to PBSC #1 or between PBSC rescue # 1 and #2. Inability to collect adequate numbers of PBSC for successful transplantation. Patient or parent/guardian refusal to remain on study.
Sites / Locations
- Children's Memorial HospitalRecruiting