Status:
UNKNOWN
Tandem Peripheral Blood Stem Cell (PBSC) Rescue for High Risk Solid Tumors
Lead Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
Conditions:
Ewing's Sarcoma
Soft Tissue Sarcoma
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE1
PHASE2
Brief Summary
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.
Detailed Description
Significant advances have been made in recent years in the treatment of solid tumors of childhood. However, much of the improvement in survival has been made in low stage and localized disease. Of sig...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00179816
Start Date
April 1 1999
End Date
September 1 2012
Last Update
October 11 2010
Active Locations (1)
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1
Children's Memorial Hospital
Chicago, Illinois, United States, 60614