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Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00028522 |
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: This phase I trial is studying the side effects and best dose of XK469 in treating patients with advanced neuroblastoma.
Condition | Intervention | Phase |
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Neuroblastoma |
Drug: R(+)XK469 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study Of R(+)XK469 In Patients With Advanced Neuroblastoma |
Estimated Enrollment: | 85 |
Study Start Date: | November 2001 |
Estimated Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Cohorts of 3-6 patients receive escalating doses of R(+)XK469 until the recommended phase II dose or maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued and treated at the recommended phase II dose (for a maximum of 20 patients treated at that dose).
Dose escalation continues as in schedule A.
PROJECTED ACCRUAL: Approximately 85 patients will be accrued for this study within 2.5-3.5 years.
Ages Eligible for Study: | 5 Years to 20 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
No active brain metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Illinois | |
University of Chicago Cancer Research Center | Recruiting |
Chicago, Illinois, United States, 60637-1470 | |
Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424 |
Study Chair: | Samir D. Undevia, MD | University of Chicago |
Study ID Numbers: | CDR0000069101, UCCRC-11108B, NCI-4570 |
Study First Received: | January 4, 2002 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00028522 |
Health Authority: | Unspecified |
disseminated neuroblastoma localized unresectable neuroblastoma recurrent neuroblastoma regional neuroblastoma |
Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Neuroectodermal Tumors, Primitive, Peripheral Recurrence Neuroblastoma Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial |