COG-ANBL1221: A Phase II Randomized Trial of Irinotecan/Temozolomide with Temsirolimus (NSC# 683864, IND# 61010) or Chimeric 14.18 Antibody (ch14.18) (NSC# 764038, IND# 4308) in Children with Refractory, Relapsed or Progressive Neuroblastoma

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COG-ANBL1221: A Phase II Randomized Trial of Irinotecan/Temozolomide with Temsirolimus (NSC# 683864, IND# 61010) or Chimeric 14.18 Antibody (ch14.18) (NSC# 764038, IND# 4308) in Children with Refractory, Relapsed or Progressive Neuroblastoma

1. To determine if the addition of a molecularly
targeted anti-cancer agent (temsirolimus or ch14.18) to the chemotherapy backbone of irinotecan and temozolomide will be tolerable and will result in improved response rates in
patients with refractory, relapsed or progressive
neuroblastoma.

2. To identify whether temsirolimus or ch14.18 is the optimal therapeutic agent to consider for
further testing in a future Phase III randomized trial for treatment of newly diagnosed high risk
neuroblastoma.

3. To compare the response rates (RR) for patients receiving temsirolimus or ch14.18 in
combination with irinotecan and temozolomide

4. To compare the progression free survival and overall survival rates for patients
receiving temsirolimus or ch14.18 in combination with irinotecan and temozolomide

5. To compare the toxicities associated with temsirolimus or ch14.18 when combined with
irinotecan and temozolomide in patients with
refractory, relapsed or progressive neuroblastoma

6. To compare the ability to maintain intended dose intensity of all agents when temsirolimus or
ch14.18 is combined with irinotecan and temozolomide in patients with refractory, relapsed or progressive neuroblastoma

7. To determine the concordance between tumor responses as defined by standard International
Neuroblastoma Response Criteria (INRC) versus response per the revised INRC.

8. To study the clinical relevance of naturally occurring anti-glycan antibodies in patients receiving ch14.18 antibody
.
9. To study the clinical relevance of NK receptor NKp30 isoforms in patients receiving ch14.18 antibody or temsirolimus
.

Protocol Number111301
Principal InvestigatorRichard Drachtman
PhasePhase II
ScopeNational
Applicable Disease SitesAny Site
Therapies InvolvedChemotherapy multiple agents systemic
Drugs InvolvedTEMSIROLIMUS
IRINOTECAN
TEMOZOLOMIDE
ch14.18
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.