Status:
COMPLETED
Temozolomide in Treating Young Patients With High-Risk Relapsed or Refractory Neuroblastoma
Lead Sponsor:
Children's Cancer and Leukaemia Group
Conditions:
Neuroblastoma
Eligibility:
All Genders
1-16 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This pha...
Detailed Description
OBJECTIVES: Primary * Determine the anti-tumor activity of temozolomide in young patients with high-risk relapsed or refractory neuroblastoma. Secondary * Determine the duration of response in pat...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically proven neuroblastoma
- High-risk relapsed or refractory disease, defined as 1 of the following:
- Metastatic disease
- Localized MYC-N amplified disease
- Localized non MYC-N amplified disease at second relapse
- Measurable primary or metastatic disease by cross-sectional imaging or MIBG scan
- PATIENT CHARACTERISTICS:
- Lansky performance status 40-100%
- Life expectancy \> 2 months
- Not pregnant or nursing
- Fertile patients must use effective contraception during the course of this study and for 6 months after study completion
- Organ toxicity \< grade 2
- Platelets ≥ 100,000/mm\^3 (50,000/mm\^3 after stem cell transplant or in case of marrow involvement)
- Neutrophil count ≥ 500/mm\^3
- Bilirubin \< 1.5 times normal
- AST and ALT ≤ 2.5 times normal
- No known HIV positivity
- PRIOR CONCURRENT THERAPY:
- More than 21 days since prior chemotherapy treatment (isotretinoin is counted as chemotherapy for this purpose)
- More than 30 days since prior radiotherapy except local palliative treatment for pain control
- No more than 2 prior treatments for neuroblastoma
- No other concurrent investigative treatment for neuroblastoma
Exclusion
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00276679
Start Date
April 1 2003
End Date
November 1 2006
Last Update
September 17 2013
Active Locations (22)
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1
Centre Hospitalier Regional de Purpan
Toulouse, France, 31026
2
Our Lady's Hospital for Sick Children
Dublin, Ireland, 12
3
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
4
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom, BS2 8AE