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

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Cancer and Leukaemia Group
• Treatments: Dacarbazine; Temozolomide

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