Phase II Study of Temozolomide (Temodal) in Children Over 1 Year of Age With Relapsed or Refractory High Risk Neuroblastoma
1 Year
16 Years
Both
Neuroblastoma
Trial Information
Phase II Study of Temozolomide (Temodal) in Children Over 1 Year of Age With Relapsed or Refractory High Risk Neuroblastoma
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 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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Herve Rubie, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Hospitalier Regional de Purpan
Authority:
United States: Federal Government
Study ID:
CDR0000454577
NCT ID:
NCT00276679
Start Date:
April 2003
Completion Date:
Related Keywords:
- Neuroblastoma
- recurrent neuroblastoma
- disseminated neuroblastoma
- localized unresectable neuroblastoma
- Neuroblastoma
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