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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00030108 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase I trial is studying the side effects and best dose of ixabepilone in treating young patients with relapsed or refractory solid tumors or leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Childhood Germ Cell Tumor Extragonadal Germ Cell Tumor Kidney Cancer Leukemia Liver Cancer Neuroblastoma Ovarian Cancer Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: ixabepilone |
Phase I |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I Trial and Pharmacokinetic Study of BMS-247550 (NSC 710428, Ixabepilone), an Epothilone B Analog, in Pediatric Patients With Refractory Solid Tumors and Leukemias |
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2001 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive ixabepilone IV over 1 hour on days 1-5. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity. Intrapatient dose escalation to one dose level above the enrollment dose level is allowed in patients who have stable or responding disease or are experiencing other benefits from therapy (e.g., decrease in tumor-related pain symptoms) and who have no grade 2 or greater non-hematologic toxicity and no grade 3 or greater hematologic toxicity. Additional patients are treated at the MTD. Patients treated at the MTD may not undergo intrapatient dose escalation.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 1-2 years.
Eligibility| Ages Eligible for Study: | 2 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
Histologically confirmed solid tumor (closed to accrual as of 10/4/2007) that relapsed after or failed to respond to front-line curative therapy and for which no other potentially curative treatment options exist
Eligible tumor types include, but are not limited to, the following:
Primary brain tumors
Diagnosis of relapsed or refractory leukemia
PATIENT CHARACTERISTICS:
Age:
Performance status:
For patients age 11 to 21:
For patients age 1 to 10:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
At least 1 week since prior known inhibitors of CYP3A4, including any of the following:
Contacts and Locations| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010-2970 | |
| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Study Chair: | AeRang Kim, MD | NCI - Pediatric Oncology Branch |
More Information
| ClinicalTrials.gov Identifier: | NCT00030108 History of Changes |
| Obsolete Identifiers: | NCT00025961 |
| Other Study ID Numbers: | CDR0000069133, NCI-02-C-0031, NCI-5425 |
| Study First Received: | January 30, 2002 |
| Last Updated: | June 4, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent childhood rhabdomyosarcoma childhood craniopharyngioma recurrent neuroblastoma recurrent childhood liver cancer recurrent Wilms tumor and other childhood kidney tumors childhood central nervous system germ cell tumor recurrent osteosarcoma unspecified childhood solid tumor, protocol specific childhood germ cell tumor recurrent childhood soft tissue sarcoma 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 recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor recurrent childhood ependymoma childhood teratoma childhood malignant testicular germ cell tumor childhood malignant ovarian germ cell tumor childhood extragonadal germ cell tumor recurrent childhood malignant germ cell tumor B-cell childhood acute lymphoblastic leukemia childhood acute basophilic leukemia childhood acute eosinophilic leukemia |
|
Carcinoma, Renal Cell Kidney Neoplasms Leukemia Liver Neoplasms Nervous System Neoplasms Neuroblastoma Ovarian Neoplasms Central Nervous System Neoplasms Neoplasms, Germ Cell and Embryonal Neoplasms Sarcoma Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Digestive System Neoplasms Digestive System Diseases Liver Diseases Nervous System Diseases Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Nerve Tissue Endocrine Gland Neoplasms |