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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00276679
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : September 17, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

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.


Condition or disease Intervention/treatment Phase
Neuroblastoma Drug: temozolomide Phase 2

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma





Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Show Show 22 study locations
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Investigators
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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
Publications of Results:
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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
Keywords provided by National Cancer Institute (NCI):
recurrent neuroblastoma
disseminated neuroblastoma
localized unresectable neuroblastoma
Additional relevant MeSH terms:
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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