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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00311584 |
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 | Intervention | Phase |
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Neuroblastoma |
Drug: irinotecan hydrochloride Drug: temozolomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Irinotecan + Temozolomide in Children With Recurrent Neuroblastoma |
Estimated Enrollment: | 50 |
Study Start Date: | April 2006 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed neuroblastoma AND/OR demonstration of tumor cells in the bone marrow with increased urinary catecholamines at initial diagnosis
Meets 1 of the following criteria:
Must meet 1 of the following criteria for documentation of disease:
Unidimensionally measurable tumor ≥ 20 mm by MRI, CT scan, or x-ray OR ≥ 10 mm by spiral CT scan within 4 weeks prior to study entry
MIBG scan with positive uptake at ≥ 1 site within 4 weeks prior to study entry
PATIENT CHARACTERISTICS:
Creatinine adjusted according to age as follows:
PRIOR CONCURRENT THERAPY:
At least 1 week since prior and no concurrent enzyme-inducing anticonvulsants (EIAC), including phenytoin, phenobarbital, valproic acid, or carbamazepine
No prior allogeneic stem cell transplantation (SCT)
No concurrent immunomodulating agents
Study Chair: | Rochelle Bagatell, MD | University of Arizona |
Investigator: | Cynthia S. Kretschmar, MD | Floating Hospital for Children at Tufts - New England Medical Center |
Responsible Party: | Children's Oncology Group - Group Chair Office ( Gregory H. Reaman ) |
Study ID Numbers: | CDR0000465487, COG-ANBL0421 |
Study First Received: | April 5, 2006 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00311584 History of Changes |
Health Authority: | United States: Federal Government |
recurrent neuroblastoma |
Neuroectodermal Tumors, Primitive Irinotecan Temozolomide Neuroblastoma Recurrence Camptothecin Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic Alkylating Agents Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |
Neuroectodermal Tumors, Primitive Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Irinotecan Enzyme Inhibitors Temozolomide Pharmacologic Actions Neuroblastoma Camptothecin |
Neuroectodermal Tumors Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Antineoplastic Agents, Phytogenic Alkylating Agents Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |