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Sponsors and Collaborators: |
New Approaches to Neuroblastoma Therapy Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00084422 |
RATIONALE: CEP-701 may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase I trial is studying the side effects and best dose of CEP-701 in treating young patients with recurrent or refractory high-risk neuroblastoma.
Condition | Intervention | Phase |
---|---|---|
Neuroblastoma |
Drug: lestaurtinib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I Study Of CEP-701 In Patients With Refractory Neuroblastoma (IND # 67,722) |
Estimated Enrollment: | 60 |
Study Start Date: | August 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Patients receive oral CEP-701 twice daily* on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
NOTE: *On day 1 of course 1 only, patients receive oral CEP-701 once instead of twice.
Cohorts of 3-6 patients receive escalating doses of CEP-701 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, the dose level is expanded up to 9 patients.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Ages Eligible for Study: | up to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of neuroblastoma confirmed by at least 1 of the following:
Patients in first response after completion of a prior front-line myeloablative regimen OR who were medically ineligible to receive a front-line myeloablative regimen must meet at least 1 of the following criteria:
Viable neuroblastoma determined by biopsy of a persistent lesion as seen on CT scan, MRI, or metaiodobenzylguanidine (MIBG) scan
Meets at least 1 of the following criteria:
At least 1 unidimensionally measurable lesion on CT scan, MRI, or X-ray
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent administration of any of the following CYP3A4 inhibitors:
United States, California | |
Childrens Hospital Los Angeles | Recruiting |
Los Angeles, California, United States, 90027-0700 | |
Contact: Judith G. Villablanca, MD 323-361-5654 jvillablanca@chla.usc.edu | |
Lucile Packard Children's Hospital at Stanford University Medical Center | Recruiting |
Palo Alto, California, United States, 94304 | |
Contact: Clare Twist, MD 650-723-5535 | |
UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Katherine K. Matthay, MD 415-476-3831 matthayk@peds.ucsf.edu | |
United States, Georgia | |
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Howard M. Katzenstein, MD 404-785-0853 | |
United States, Illinois | |
University of Chicago Comer Children's Hospital | Recruiting |
Chicago, Illinois, United States, 60637 | |
Contact: Susan L. Cohn, MD 773-703-2571 scohn@peds.bsd.uchicago.edu | |
United States, Massachusetts | |
Children's Hospital Boston | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Suzanne Shusterman, MD 617-632-4901 suzanne_shusterman@dfci.harvard.edu | |
United States, Michigan | |
University of Michigan Comprehensive Cancer Center | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Gregory Yanik, MD 734-936-8785 gyanik@umich.edu | |
United States, New York | |
Morgan Stanley Children's Hospital of New York-Presbyterian | Recruiting |
New York, New York, United States, 10032 | |
Contact: Julia L. Glade-Bender, MD 212-305-3379 Jg589@columbia.edu | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | Recruiting |
Cincinnati, Ohio, United States, 45229-3039 | |
Contact: John P. Perentesis, MD 513-636-6090 john.perentesis@chmcc.org | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19104-4318 | |
Contact: John M. Maris, MD 215-590-2821 maris@chop.edu | |
United States, Texas | |
Cook Children's Medical Center - Fort Worth | Recruiting |
Fort Worth, Texas, United States, 76104 | |
Contact: Clinical Trials Office - Cook's Children's Medical Center 682-885-2103 | |
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital | Recruiting |
Houston, Texas, United States, 77030-2399 | |
Contact: Heidi V. Russell, MD 832-822-4277 hmrussel@txccc.org | |
United States, Washington | |
Children's Hospital and Regional Medical Center - Seattle | Recruiting |
Seattle, Washington, United States, 98105 | |
Contact: Julie R. Park, MD 206-987-2106 | |
United States, Wisconsin | |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Recruiting |
Madison, Wisconsin, United States, 53792-6164 | |
Contact: Paul M. Sondel, MD, PhD 608-263-9069 pmsondel@humonc.wisc.edu | |
Canada, Ontario | |
Hospital for Sick Children | Recruiting |
Toronto, Ontario, Canada, M5G 1X8 | |
Contact: Sylvain Baruchel, MD 416-813-7795 |
Study Chair: | John M. Maris, MD | Children's Hospital of Philadelphia |
Investigator: | Garrett M. Brodeur, MD | Children's Hospital of Philadelphia |
Study ID Numbers: | CDR0000363630, NANT-2001-03 |
Study First Received: | June 10, 2004 |
Last Updated: | December 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00084422 |
Health Authority: | Unspecified |
recurrent 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 |