Status:
TERMINATED
Neuroblastoma Protocol 2008: Therapy for Children With Advanced Stage High Risk Neuroblastoma
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Neuroblastoma
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
Brief Summary
A Phase II study of temsirolimus in combination with standard chemotherapy (irinotecan; cyclophosphamide, doxorubicin and etoposide (CAE); cisplatin and etoposide (HiPE) and topotecan (TPT) followed b...
Detailed Description
All children will receive fixed doses of intravenous temsirolimus (50 mg/m2 weekly 6 times ) concomitantly with two courses of fixed dosages of irinotecan (20 mg/m2 intravenously daily 5 times ,2 days...
Eligibility Criteria
Inclusion
- Patients \<18 years old with newly diagnosed, advanced stage, high-risk neuroblastoma defined as one of the following:
- Children \< 1 yo with International Neuroblastoma Staging System (INSS) stage 2a, 2b, 3, 4 or 4S disease and MYCN amplification (\>10 copies, or greater than four-fold increase in MYCN signal as compared to reference signal)
- INSS 2a or 2b disease and MYCN amplification, regardless of age or additional biologic features
- INSS stage 3 and:
- MYCN amplification (\>10 copies, or greater than four-fold increase in MYCN signal as compared to reference signal, regardless of age or additional biologic features
- Age \> 18 mo (\> 547 days) with unfavorable pathology, regardless of MYCN status
- INSS stage 4 and:
- MYCN amplification, regardless of age or additional biologic features
- Age \> 18 months (\> 547 days) regardless of biologic features
- Age 12 - 18 months (365 - 547 days) with any of the following three unfavorable biologic features (MYCN amplification, unfavorable pathology and/or DNA index =1) or any biologic feature that is indeterminant/unknown
- Children less than or equal to 365 days initially diagnosed with: INSS stage 1, 2, 4S who progressed to a stage 4 without interval chemotherapy.
- Histologic proof of neuroblastoma or positive bone marrow for tumor cells with increased urine catecholamines.
- Adequate renal and hepatic function (serum creatinine \<3 x upper limit of normal for age, (AST) aspartate aminotransferase \< 3 x upper limit of normal).
- No prior therapy, unless an emergency situation requires local tumor treatment (discuss with PI)
- Written, informed consent according to institutional guidelines
Exclusion
- Any evidence, as judged by the investigator, of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).
- Pregnant or breast feeding (women of child-bearing potential).
- Children with INSS 4 disease, age \<12 months with all 3 favorable biologic features (non-amplified MYCN, favorable pathology and DNA index \>1).
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00808899
Start Date
December 1 2008
End Date
July 1 2009
Last Update
May 30 2017
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105