ANBL1221: A Phase II Randomized Trial of Irinotecan/Temozolomide with Temsirolimus (NSC#683864, IND#61010) or Chimeric 14.18 Antibody (ch14.18) (NSC# 623408, IND# 4308) in Children with Refractory, Relapsed or Progressive Neuroblastoma.

Protocol: 
AAAL5208
Phase: 
II

ANBL1221: A Phase II Randomized Trial of Irinotecan/Temozolomide with Temsirolimus (NSC#683864, IND#61010) or Chimeric 14.18 Antibody (ch14.18) (NSC# 623408, IND# 4308) in Children with Refractory, Relapsed or Progressive Neuroblastoma.

This is a Phase II randomized study of Irinotecan/Temozolomide with Temsirolimus or chimeric antibody 14.18 (Ch 14.18) in children with refractory, relapsed, or progressive neuroblastoma. This study will enroll participants who have the type of neuroblastoma that has come back after treatment (relapsed) or has not responded to treatment (refractory). Enrolled subjects will be treated with irinotecan and temozolomide combined with temisirolimus or irinotecan and temozolomide with chimeric 14.8 antibody (ch14.8). Temsirolimus and ch 14.18 are both experimental drugs that have not yet been approved by the Food and Drug Administration (FDA) for treating relapsed or refractory neuroblastoma. Standard Medical tests will be performed such as physical exams, blood tests, bone marrow tests, imaging, tests of kidney, lung and heart function, and urine tests. The treatment portion of the study may last for a maximum of 12 months. It is anticipated that a maximum of 74 patients will be treated overall on this study, and it is anticipated that 6 will be treated at Columbia University Medical Center.

Are you Eligible? (Inclusion Criteria)

-Subjects may be any age at the time of enrollment.
-Patients must have been diagnosed with neuroblastoma.
-Patients must have disease that is progressive, relapsed, or is refractory
to prior therapy.
-Patients must also meet all eligibility criteria as outlined in the study
protocol.

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States