Status:
TERMINATED
A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) in High Risk Abdominal Neuroblastoma
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
Mayo Clinic
Conditions:
Abdominal Neuroblastoma
Eligibility:
All Genders
6-18 years
Phase:
PHASE2
Brief Summary
High risk neuroblastoma (NB) is an aggressive, prevalent non-brain cancer derived from nerve cells of the body. It mostly affects infants, and more children die from this tumor each year than are cure...
Detailed Description
Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen will be eligible to enroll prior to surgical resection of the primary tumor. Following implant...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Mucositis ≤ Grade 2
- Patient stable on room air
- Albumin \> 3 g/dL without albumin infusions for 1 week
- Serum creatinine should be \< 1.5 x normal for age
- Lansky score \>60
- Risk Strata Eligibility: Patients between 6 months and 18 years of age with newly diagnosed abdominal primary, high-risk neuroblastoma defined as one of the following:
- International agreement on staging (INSS) stage 2a or 2b with N-myc (MYCN) amplification (greater than four-fold increase in (MYCN) signals as compared to reference signals), regardless of age or additional biologic features
- INSS stage 3 with either MYCN amplification (greater than four-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features, or for age \> 18 months with unfavorable pathology, regardless of MYCN status
- INSS stage 4 with MYCN amplification (greater than four-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features, or for age \>18 months with unfavorable pathology, regardless of MYCN status
- INSS stage 4S with MYCN amplification (greater than four-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features
- Exceptional Cases Still Considered Eligible:
- Prior palliative radiotherapy if not related to the primary site, however, children receiving definitive radiotherapy as a part of the pre-enrollment regimen are ineligible. Prior treatment regimen must follow the guidelines of an applicable high-risk neuroblastoma regimen. Slight variations from this timeframe are acceptable based on recovery of blood counts or other concerns left to the discretion of the treating radiation oncologist.
- Patients receiving surgical management elsewhere are still considered eligible to enroll on protocol therapy for assessment of the primary local control objective, renal motion and toxicity assessment. Target motion objectives may be excluded from the analysis of these patients.
- Exclusion Criteria
- Patients who have received prior definitive radiotherapy at or adjacent to the primary abdominal tumor bed.
- Patients who are unable to cooperate with acquisition of 4-dimensional computed tomography (4DCT), computed tomography (CT) or magnetic resonance imaging- (MRI)-based imaging procedures.
- Patients with known brain metastases.
- Any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).
- Pregnant women.
- Mediastinal primary tumors.
- Patients receiving surgery elsewhere, or at St. Jude within 3 months prior to study activation, are excluded from assessment of target and motion objectives. However they are still eligible to enroll for assessment of the primary objective, renal motion and toxicity.
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01440283
Start Date
September 1 2011
End Date
March 1 2015
Last Update
March 3 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105