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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00036959 |
RATIONALE: Drugs used in chemotherapy, such as ABT-751, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase I trial is studying the side effects of ABT-751 in treating young patients with refractory solid tumors.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors Childhood Germ Cell Tumor Extragonadal Germ Cell Tumor Kidney Cancer Liver Cancer Neuroblastoma Ovarian Cancer Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: ABT-751 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase I Trial and Pharmacokinetic Study of ABT-751, an Orally Bioavailable Tubulin Binding Agent, on a 7 Day and 21 Day Dosing Schedule in Pediatric Patients With Refractory Solid Tumors |
Estimated Enrollment: | 90 |
Study Start Date: | March 2002 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter, dose-escalation study of 2 different schedules of ABT-751. Patients are assigned to 1 of 2 dosing schedules.
On each schedule, cohorts of 3-6 patients receive escalating doses of ABT-751 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, up to 9 patients (a minimum of 3 patients age 11 and under and 3 patients age 12 to 18) are treated at the MTD.
PROJECTED ACCRUAL: A maximum of 90 patients will be accrued for this study within 8 months.
Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor*, including, but not limited to, the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
No concurrent growth factors (e.g., GM-CSF) except epoetin alfa
Chemotherapy:
Endocrine therapy:
Patients with brain tumors:
Radiotherapy:
Surgery:
Other:
United States, Illinois | |
Children's Memorial Hospital - Chicago | |
Chicago, Illinois, United States, 60614 | |
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
Bethesda, Maryland, United States, 20892-1182 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104-4318 |
Principal Investigator: | Frank M. Balis, MD | NCI - Pediatric Oncology Branch |
Study ID Numbers: | CDR0000069344, NCI-02-C-0141L, ABBOTT-M01-357 |
Study First Received: | May 13, 2002 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00036959 |
Health Authority: | United States: Food and Drug Administration |
metastatic osteosarcoma childhood infratentorial ependymoma recurrent childhood rhabdomyosarcoma childhood supratentorial ependymoma childhood craniopharyngioma disseminated neuroblastoma recurrent neuroblastoma recurrent childhood liver cancer stage IV childhood liver cancer recurrent Wilms tumor and other childhood kidney tumors stage IV Wilms tumor childhood central nervous system germ cell tumor recurrent osteosarcoma unspecified childhood solid tumor, protocol specific childhood germ cell tumor |
metastatic childhood soft tissue sarcoma recurrent childhood soft tissue sarcoma childhood high-grade cerebral astrocytoma childhood oligodendroglioma childhood choroid plexus tumor childhood grade I meningioma childhood grade II meningioma childhood grade III meningioma recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma recurrent childhood medulloblastoma recurrent childhood visual pathway and hypothalamic glioma previously treated childhood rhabdomyosarcoma metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor |
Liver Diseases Neuroectodermal Tumors, Primitive Malignant mesenchymal tumor Urogenital Neoplasms Central Nervous System Neoplasms Urologic Neoplasms Osteogenic sarcoma Neoplasms, Connective and Soft Tissue Ewing's sarcoma Neuroepithelioma Glioma Kidney Diseases Nervous System Neoplasms Rhabdomyosarcoma Endocrine Gland Neoplasms |
Digestive System Neoplasms Astrocytoma Genital Neoplasms, Female Endocrine System Diseases Renal cancer Testicular Neoplasms Carcinoma Neuroectodermal Tumors Sarcoma Gastrointestinal Neoplasms Testicular cancer Neoplasms, Glandular and Epithelial Choroid Plexus Neoplasms Gonadal Disorders Ewing's family of tumors |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Neoplasms, Nerve Tissue |
Nervous System Diseases Neoplasms, Neuroepithelial Adnexal Diseases |