Irinotecan and Temozolomide in Treating Young Patients With Recurrent Neuroblastoma
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|ClinicalTrials.gov Identifier: NCT00311584|
Recruitment Status : Completed
First Posted : April 6, 2006
Results First Posted : January 16, 2014
Last Update Posted : September 30, 2014
RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving irinotecan together with temozolomide works in treating young patients with recurrent neuroblastoma.
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma||Drug: irinotecan hydrochloride Drug: temozolomide||Phase 2|
- Determine the response rate in pediatric patients with relapsed neuroblastoma (NB) treated with irinotecan hydrochloride and temozolomide.
- Determine the toxicities associated with irinotecan and temozolomide in patients treated with this regimen.
- Evaluate the impact of p53 loss of function on response rate and event-free survival from start of relapse therapy.
- Collect data for ongoing analyses of UGT1A1 polymorphisms in these patients.
- Collect and bank serum and nucleic acid specimen to facilitate future biomarker studies.
- Evaluate the feasibility of collecting blood samples on a group wide basis for assessment of changes in circulating markers of angiogenesis.
- Assess, preliminarily, the effects of irinotecan hydrochloride and temozolomide on circulating markers of angiogenesis.
OUTLINE: This is a multicenter study.
Patients are stratified according to disease status (measurable disease [measured by conventional CT scan and/or MRI] vs evaluable disease [tumor detected by conventional morphologic analysis of bone marrow aspirate/biopsy AND/OR abnormal uptake at ≥ 1 site on MIBG scan]).
Patients receive irinotecan hydrochloride IV over 1 hour on days 1-5 and 8-12 and oral temozolomide on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 10 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Irinotecan + Temozolomide in Children With Recurrent Neuroblastoma|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||December 2013|
Experimental: Disease measurable by CT or MRI scan (Irinotecan/Temozolomide)
Measurable by CT scan (Computed Tomography) or MRI scan (Magnetic Resonance Imaging). Patients receive irinotecan hydrochloride IV (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: irinotecan hydrochloride
Experimental: Disease eval by bone marrow or MIBG (Irinotecan/Temozolomide)
Evaluation by bone marrow or MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical). Patients receive irinotecan hydrochloride IV (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: irinotecan hydrochloride
- Overall Response - Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR) [ Time Frame: up to 6 courses of therapy, or about 6 months ]The patient's best overall response obtained during Reporting Periods 1 and 2 will be scored as "best response". Patients enrolled on Stratum 1 with bone marrow disease, a responder has no tumor cells detectable by routine morphology on 2 subsequent bilateral bone marrow aspirates and biopsies done at least 3 weeks apart. For patients enrolled on stratum 1 with MIBG only disease, response will be assessed using the Curie scale. Patients who have complete resolution of all MIBG positive lesions (CR) or resolution of at least one MIBG positive lesion with persistence of other lesions (PR) will be considered responders. For Stratum 2 a responder is defined to be a patient who achieves a best overall response of CR, VGPR or PR from CT/MRI scans from central review using (RECIST) Response Evaluation Criteria in Solid Tumor. A responder is defined to be a patient who achieves a best overall response of CR (Complete Response), VGPR (Very Good Partial Response) or PR (Partial Response).
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): NCT00311584
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|Study Chair:||Rochelle Bagatell, MD||University of Arizona|
|Study Chair:||Cynthia S. Kretschmar, MD||Floating Hospital for Children at Tufts - New England Medical Center|