Bortezomib in Treating Children With Advanced Solid Tumors
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00021216 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : April 15, 2015
|
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | July 11, 2001 | |||
First Posted Date ICMJE | January 27, 2003 | |||
Last Update Posted Date | April 15, 2015 | |||
Study Start Date ICMJE | November 2001 | |||
Actual Primary Completion Date | December 2005 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
|
|||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Bortezomib in Treating Children With Advanced Solid Tumors | |||
Official Title ICMJE | A Phase I Study Of PS-341 In Pediatric Patients With Refractory Solid Tumors | |||
Brief Summary | Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Phase I trial to study the effectiveness of bortezomib in treating children who have advanced solid tumors that have not responded to previous treatment. | |||
Detailed Description | PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of bortezomib in pediatric patients with refractory solid tumors. II. Determine the dose-limiting toxicity and other toxic effects of this regimen in these patients. III. Preliminarily determine the antitumor activity of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of bortezomib 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. If dose-limiting toxicity in the form of myelosuppression occurs in stratum I, dose escalation continues with patients meeting the qualifications for stratum II. PROJECTED ACCRUAL: Approximately 24-36 patients will be accrued for this study. |
|||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||
Condition ICMJE | Unspecified Childhood Solid Tumor, Protocol Specific | |||
Intervention ICMJE |
|
|||
Study Arms ICMJE | Experimental: Treatment (bortezomib)
Patients receive bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions:
|
|||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
36 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | December 2005 | |||
Actual Primary Completion Date | December 2005 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | up to 21 Years (Child, Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | Australia, Canada | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00021216 | |||
Other Study ID Numbers ICMJE | NCI-2012-01860 NCI-2012-01860 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) COG-ADVL0015 CDR0000068760 ADVL0015 ( Other Identifier: Children's Oncology Group ) ADVL0015 ( Other Identifier: CTEP ) U01CA097452 ( U.S. NIH Grant/Contract ) |
|||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | National Cancer Institute (NCI) | |||
Original Responsible Party | Not Provided | |||
Current Study Sponsor ICMJE | National Cancer Institute (NCI) | |||
Original Study Sponsor ICMJE | Children's Oncology Group | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | National Cancer Institute (NCI) | |||
Verification Date | December 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |