|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00077467 |
Purpose
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib in treating young patients with refractory or recurrent leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: bortezomib |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase I Study of PS-341 (Velcade, Bortezomib) in Pediatric Patients With Refractory/Recurrent Leukemias |
| Study Start Date: | January 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation, open-label, multicenter study.
Patients receive bortezomib IV over 3-5 seconds 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.
PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 1.5-36 months.
Eligibility| Ages Eligible for Study: | 1 Year to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed leukemia of 1 of the following types:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
NOTE: **An exception may be made at the discretion of the investigator
Hepatic
Renal
Creatinine based on age as follows:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent anticonvulsant medications known to activate the cytochrome p450 system (e.g., phenytoin, carbamazepine, or phenobarbital)
Contacts and Locations| United States, California | |
| Stanford Cancer Center at Stanford University Medical Center | |
| Palo Alto, California, United States | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States | |
| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States | |
| United States, Minnesota | |
| Fairview University Medical Center - University Campus | |
| Minneapolis, Minnesota, United States | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States | |
| United States, New York | |
| SUNY Upstate Medical University Hospital | |
| Syracuse, New York, United States | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States | |
| United States, Oregon | |
| Cancer Institute at Oregon Health and Science University | |
| Portland, Oregon, United States | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States | |
| Children's Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States | |
| United States, Texas | |
| Baylor University Medical Center - Houston | |
| Houston, Texas, United States | |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | |
| Dallas, Texas, United States | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center - Seattle | |
| Seattle, Washington, United States | |
| Canada, Quebec | |
| Hopital Sainte Justine | |
| Montreal, Quebec, Canada | |
| Study Chair: | Terzah M. Horton, MD, PhD | Texas Children's Cancer Center |
| Investigator: | Lisa Bomgaars, MD | Texas Children's Cancer Center |
More Information
| Study ID Numbers: | CDR0000350340, COG-ADVL0317 |
| Study First Received: | February 10, 2004 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00077467 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia blastic phase chronic myelogenous leukemia childhood acute promyelocytic leukemia (M3) |
|
Leukemia Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Bortezomib Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |