Temozolomide in Treating Young Patients With High-Risk Relapsed or Refractory Neuroblastoma
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| ClinicalTrials.gov Identifier: NCT00276679 |
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Recruitment Status :
Completed
First Posted : January 13, 2006
Last Update Posted : September 17, 2013
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neuroblastoma | Drug: temozolomide | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Allocation: | Non-Randomized |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Study of Temozolomide (Temodal) in Children Over 1 Year of Age With Relapsed or Refractory High Risk Neuroblastoma |
| Study Start Date : | April 2003 |
| Actual Study Completion Date : | November 2006 |
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| Ages Eligible for Study: | 1 Year to 16 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically proven neuroblastoma
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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
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- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276679
Show 22 study locations
| Study Chair: | Herve Rubie, MD | Centre Hospitalier Regional de Purpan | |
| OverallOfficial: | Andrew David J. Pearson, MD, FRCP, DCh | University of Newcastle Upon-Tyne | |
| OverallOfficial: | Julia Chisholm, MD | Great Ormond Street Hospital for Children NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT00276679 |
| Other Study ID Numbers: |
CDR0000454577 CCLG-NAG-2003-02 EU-20591 CCLG-SFOP-NAG-2003-02 |
| First Posted: | January 13, 2006 Key Record Dates |
| Last Update Posted: | September 17, 2013 |
| Last Verified: | January 2006 |
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recurrent neuroblastoma disseminated neuroblastoma localized unresectable neuroblastoma |
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Neuroblastoma Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Temozolomide Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |