A Phase 1 interventional study of ABT-751 in Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor and Extragonadal Germ Cell Tumor, sponsored by National Institutes of Health Clinical Center (CC). Completed at 3 sites in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2012-03-15.
Sponsored by National Institutes of Health Clinical Center (CC) · Phase 1, Interventional, and Treatment
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.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 90 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →National Institutes of Health Clinical Center (CC) is the lead sponsor of 367 studies on the registry; 27 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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National Institutes of Health Clinical Center (CC)