NCT00135135

Neuroblastoma Protocol 2005: Therapy for Children With Advanced Stage High-Risk Neuroblastoma

Completed Phase 2 Last updated 2 June 2008

What this trial tests

Phase 2 trial testing Gefitinib, Irinotecan, Cycophosphamide, Doxorubicin, Etoposide, Cisplatin, Topotecan, Carboplatin, Melphalan, 13-cis retinoic acid in Neuroblastoma in 23 participants. Completed in 1 June 2007.

Timeline

1 August 2005

Primary endpoint
1 June 2007

1 June 2007

Quick facts

Lead sponsor	St. Jude Children's Research Hospital
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	23
Start date	1 August 2005
Primary completion	1 June 2007
Estimated completion	1 June 2007
Sites	1 location across United States

Drugs / interventions tested

• Gefitinib, Irinotecan, Cycophosphamide, Doxorubicin, Etoposide, Cisplatin, Topotecan, Carboplatin, Melphalan, 13-cis retinoic acid
• Radiation therapy, Surgery, Peripheral Stem cell transplant

Conditions studied

• Neuroblastoma — all drugs for Neuroblastoma →

Sponsor

St. Jude Children's Research Hospital

Who can join

Under 18, any sex, with Neuroblastoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Response rate
  Time frame: Within 30 days of completion of window therapy.

Sponsor's own description

This is a phase II window study of the combination of ZD1839 (gefitinib) and irinotecan in children with high-risk neuroblastoma followed by standard induction chemotherapy, intensification with autologous stem cell transplantation, and an oral maintenance phase with 13-cis-retinoic acid and topotecan. We hypothesize that the ZD1839 (gefitinib) and irinotecan window will be efficacious.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. The role of inherited TPMT and COMT genetic variation in cisplatin-induced ototoxicity in children with cancer.
   Yang JJ, Lim JY, Huang J, Bass J, et al · · 2013 · cited 74× · PMID 23820299 · DOI 10.1038/clpt.2013.121
2. A single-arm pilot phase II study of gefitinib and irinotecan in children with newly diagnosed high-risk neuroblastoma.
   Furman WL, McGregor LM, McCarville MB, Onciu M, et al · · 2012 · cited 21× · PMID 21796439 · DOI 10.1007/s10637-011-9724-3
3. Epidermal growth factor receptor polymorphisms and risk for toxicity in paediatric patients treated with gefitinib.
   McKibbin T, Zhao W, Tagen M, Daw NC, et al · · 2010 · cited 13× · PMID 20621735 · DOI 10.1016/j.ejca.2010.05.007
4. What value do zebrafish have to anticancer drug discovery?
   Xiao B, Landesman-Bollag E, Feng H. · · 2024 · cited 1× · PMID 38327017 · DOI 10.1080/17460441.2024.2313454
5. Chemoprevention of neuroblastoma: progress and promise beyond uncertainties.
   Aravindan N, Natarajan M, Somasundaram DB, Aravindan S. · · 2023 · cited 1× · PMID 38249515 · DOI 10.20517/2394-4722.2022.40