NCT00808899

Neuroblastoma Protocol 2008: Therapy for Children With Advanced Stage High Risk Neuroblastoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 by and additional six courses of induction chemotherapy and then intensification with autologous hematopoietic stem cell transplantation. The first five courses of induction chemotherapy will also evaluate the feasibility of combining weekly temsirolimus with these standard chemotherapy combinations. This will be followed by 16 months of oral maintenance therapy with eight months of 13-cis-retinoic acid and then eight months of oral topotecan.

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 off, repeated daily 5 times .If these initial dosages are not tolerable then subsequent patients will be given a reduced dosage of temsirolimus (25 mg/m2 weekly 6 times) with 20 mg/m2 of irinotecan.If this dosage combination is not tolerable, the irinotecan dosage will be decreased to 15 mg/m2 .If this dosage combination is not tolerable then further enrollment to the initial six week treatment will be terminated.The second course of irinotecan will begin on day 22 and response will be determined after six weeks (two courses). Resection of primary tumor will be attempted after this initial therapy, whenever possible. Following initial treatment children will undergo alternating courses of induction chemotherapy with cyclophosphamide, doxorubicin, etoposide, topotecan, and cisplatin (Block 2). The first cohort of 17 patients will receive Block 2 with temsirolimus (50mg/m2) for all three courses, weekly 2 times. If this is not tolerated subsequent patients will receive Block 2 chemotherapy with reduced dosages of temsirolimus (25mg/m2).

Conditions

• Neuroblastoma

Interventions

Type	Name	Description
DRUG	Temsirolimus	Temsirolimus
DRUG	Irinotecan	Irinotecan
PROCEDURE	Surgical Resection of Primary Tumor	Surgical Resection of Primary Tumor
DRUG	Cyclophosphamide	Cyclophosphamide
DRUG	Doxorubicin	Doxorubicin
DRUG	Etoposide	Etoposide
DRUG	Cisplatin	Cisplatin
DRUG	Topotecan	Topotecan
PROCEDURE	PBSC	Peripheral Blood Stem Cell Harvest
RADIATION	Radiation Therapy	Radiation Therapy
DRUG	13-cis-retinoic acid	13-cis-retinoic acid

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2008-12-16
• Last updated: 2017-05-30
• Results posted: 2010-05-20

Locations

1 site across 1 country: United States