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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00276679

Enrollment

Unknown

Registered

2006-01-13

Start date

2003-04-30

Completion date

2006-11-30

Last updated

2013-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroblastoma

Keywords

recurrent neuroblastoma, disseminated neuroblastoma, localized unresectable neuroblastoma

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

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 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.

Interventions

DRUGtemozolomide

Study design

Allocation

NON_RANDOMIZED

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 16 Years

Healthy volunteers

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

Countries

France, Ireland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026