Status:
COMPLETED
Intensive Chemo-Radiotherapy With Peripheral Blood Progenitor Cell Rescue for Children With Advanced Neuroblastoma and Sarcomas
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Boston Children's Hospital
Children's Hospital of Philadelphia
Conditions:
Neuroblastoma
Ewings Sarcoma
Eligibility:
All Genders
Up to 19 years
Phase:
PHASE2
Brief Summary
The main purpose of this study is to determine the short and long term side effects of a very intensive treatment, which includes combinations of chemotherapy drugs followed by radiation therapy and t...
Detailed Description
* The treatment is separated into three stages: 1) Initial treatment-chemotherapy and stem cell collection; 2) Treatment targeted directly to the main tumor-surgery and radiation therapy; 3) Intensifi...
Eligibility Criteria
Inclusion
- Previously untreated neuroblastoma Stage D \> 365 days
- Previously untreated neuroblastoma Stage C at age \> 365 days with n-myc amplification
- Previously untreated metastatic Ewings sarcoma/PNET
- Previously untreated non-rhabdomyosarcoma soft tissue sarcoma
- Confirmation of neuroblastoma at time of diagnosis by histologic specimen or with bone marrow specimen showing solid tumor. Confirmation of sarcoma by histologic specimen with evidence of metastatic disease be imaging study
- Patient 19 years of age or younger
- ANC \> 1000
- Platelet count \> 75,000
- SGOT \< 2.5 x ULN
- Normal serum creatinine levels for age
Exclusion
- Previous malignancy requiring nonsurgical treatment or bone marrow transplant.
- Relapsed disease
Key Trial Info
Start Date :
January 1 1996
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00165139
Start Date
January 1 1996
End Date
February 1 2009
Last Update
November 2 2009
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115