Soft Tissue Sarcoma Clinical Trial
Official title:
High-Dose Chemotherapy With Tandem Peripheral Blood Stem Cell (PBSC) Rescue for the Treatment of High-Risk Pediatric Solid Tumors.
This study uses a double autologous peripheral blood stem cell rescue (PBSC) following dose-intensive chemotherapy for the treatment of high-risk pediatric solid tumors.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 21 Years |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Children's Memorial Hospital | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Ann & Robert H Lurie Children's Hospital of Chicago |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the feasibility and toxicity of tandem PBSC rescue following high dose chemotherapy as consolidation in pediatric patients with high risk solid tumors. | annually | Yes | |
Secondary | Evaluate length of remission and long term disease free survival in chemotherapy responsive high-risk pediatric solid tumor patients treated using this approach. | Annually | Yes | |
Secondary | Evaluate correlation between cell dose and time to engraftment in high-risk pediatric solid tumor patients treated using this approach. | Time to engraftment | Yes |
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