Clinical trial · Interventional
Therapy for Children With Neuroblastoma
Neuroblastoma Protocol 2005: Therapy for Children With Advanced Stage High-Risk Neuroblastoma
NCT00135135CI-TRIAL-00001499completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gefitinib, Irinotecan, Cycophosphamide, Doxorubicin, Etoposide, Cisplatin, Topotecan, Carboplatin, Melphalan, 13-cis retinoic acid | Drug | — | UNRESOLVED |
| Radiation therapy, Surgery, Peripheral Stem cell transplant | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- 1
- interventionNames
- Drug: Gefitinib, Irinotecan, Cycophosphamide, Doxorubicin, Etoposide, Cisplatin, Topotecan, Carboplatin, Melphalan, 13-cis retinoic acid
- Procedure: Radiation therapy, Surgery, Peripheral Stem cell transplant
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- Within 30 days of completion of window therapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient is less than or equal to 18 years of age * Patient is newly diagnosed with high-risk neuroblastoma * Patient has adequate kidney and liver function * No prior therapy, unless an emergency situation requires local tumor treatment (discuss with PI) Exclusion Criteria: * Known severe hypersensitivity to ZD1839 or any of the excipients of this product * Any evidence, as judged by the investigator, of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) * Evidence of any significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial. * Pregnant or breast feeding (women of child-bearing potential). * Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St. John's Wort. * Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment. * Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded). * Children with INSS 4 disease, age \<12 months with all 3 favorable biologic features (non-amplified MYCN, favorable pathology and DNA index
References
Publications (0)
Data not yet available
No reference posted for this study.