Phase II Study of Temozolomide (Temodal) in Children Over 1 Year of Age With Relapsed or Refractory High Risk Neuroblastoma
- Determine the anti-tumor activity of temozolomide in young patients with high-risk
relapsed or refractory neuroblastoma.
- Determine the duration of response in patients treated with this drug.
- Determine tolerability of this drug in these patients
- Determine the tumor expression of the cellular repair mechanisms which repair DNA
damage (O6-methylguanine-DNA methyltransferase [MGMT] and mismatch repair [MMR]
systems) in patients treated with this drug.
- Correlate MGMT and MMR expression with outcomes in patients treated with this drug.
- Determine if MGMT and MMR expression/activity changes in the tumor during initial
presentation, treatment, and relapse/progression in patients treated with this drug.
- Determine the activity of MGMT in bone marrow taken at relapse, in terms of
hematological toxicity, in patients treated with this drug.
OUTLINE: This is a multicenter, open label, nonrandomized study.
Patients receive oral temozolomide once daily for 5 days. Treatment repeats every 28 days
for 2 courses. Patients achieving stable or responding disease after completion of the 2
courses may receive up to 10 additional courses of treatment in the absence of disease
progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Herve Rubie, MD
Centre Hospitalier Regional de Purpan
United States: Federal Government