Temozolomide in Treating Young Patients With High-Risk Relapsed or Refractory Neuroblastoma

Study Overview
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Brief Summary
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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 phase II trial is studying how well temozolomide works in treating patients with high-risk relapsed or refractory neuroblastoma.

Detailed Description
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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.

Official Title
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Phase II Study of Temozolomide (Temodal) in Children Over 1 Year of Age With Relapsed or Refractory High Risk Neuroblastoma

Conditions
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Neuroblastoma

Intervention / Treatment
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* Drug: temozolomide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: temozolomide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent neuroblastoma, disseminated neuroblastoma, localized unresectable neuroblastoma