Therapy for Children With Neuroblastoma
Part of paid clinical trials in Memphis, Tennessee.
- Sponsor
- St. Jude Children's Research Hospital
- Study ID
- NCT00135135
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - 18 Years
- Healthy Volunteers
- Not accepted
Interventions
- Gefitinib, Irinotecan, Cycophosphamide, Doxorubicin, Etoposide, Cisplatin, Topotecan, Carboplatin, Melphalan, 13-cis retinoic acid — DRUGSee Detailed Description.
- Radiation therapy, Surgery, Peripheral Stem cell transplant — PROCEDURESee Detailed Description.
Study Details
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.
Key Dates
- Start date
- Aug 31, 2005
- Status verified
- Jun 2008
- Primary completion
- Jun 30, 2007
- Completion
- Jun 30, 2007
Study Design
- Enrollment
- 23 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Other: 1
Primary Outcome Measure
Response rate [ Time Frame: Within 30 days of completion of window therapy. ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | - |
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