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Home > "B" Clinical Trials Conditions > Bortezomib in Treating Children With Advanced Solid Tumors  Bortezomib in Treating Children With Advanced Solid Tumors
Bortezomib in Treating Children With Advanced Solid Tumors
For Condition: unspecified childhood solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): Children's Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of bortezomib in treating children who have advanced solid tumors that have not responded to previous treatment.
Details: OBJECTIVES: - Determine the maximum tolerated dose of bortezomib in pediatric patients with refractory solid tumors. - Determine the dose-limiting toxicity and other toxic effects of this regimen in these patients. - 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy exists - Histologic confirmation not required for brainstem glioma or optic pathway tumor - Ineligible for therapies of higher priority - Stratum II only: - No bone marrow involvement PATIENT CHARACTERISTICS: Age: - Under 22 Performance status: - Karnofsky 50-100% (over 10 years of age) - Lansky 50-100% (10 years of age and under) Life expectancy: - At least 8 weeks Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 75,000/mm^3 (transfusion independent) - Hemoglobin at least 8 g/dL (RBC transfusions allowed) Hepatic: - Bilirubin less than 1.5 mg/dL - ALT less than 5 times normal for age - Albumin at least 2 g/dL Renal: - Creatinine no greater than upper limit of normal for age OR - Creatinine clearance or radioisotope glomerular filtration rate greater than 70 mL/min Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Neurologic deficits related to CNS tumors allowed if relatively stable for at least 2 weeks - No uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 7 days since prior biologic therapy and recovered - At least 3 months since prior allogeneic stem cell transplantation - At least 1 week since prior growth factors - Stratum II only: - No prior stem cell transplantation with or without total body irradiation Chemotherapy: - At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas) and recovered - Stratum II only: - No more than 2 prior multi-agent chemotherapy regimens - More than 2 single-agent regimens allowed Endocrine therapy: - Concurrent dexamethasone allowed for CNS tumors if stable dose for at least 2 weeks Radiotherapy: - See Biologic therapy - At least 2 weeks since prior palliative local radiotherapy - At least 6 months since prior craniospinal radiotherapy or radiotherapy to at least 50% of pelvis - At least 6 weeks since prior substantial bone marrow radiotherapy - Recovered from prior radiotherapy - Stratum II only: - No prior radiotherapy to more than 20% of bone marrow Surgery: - Not specified Other: - No prior bortezomib - No concurrent anticonvulsants - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SusanBlaney, Study Chair, Texas Children's Cancer Center
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Canada
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Canada
Children's Hospital of Michigan
Detroit, Michigan, 48201
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Memphis, Tennessee, 38105-2794
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Children's Hospital of Denver
Denver, Colorado, 80218-1088
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Children's Hospital of Orange County
Orange, California, 92868
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
United States
Columbia Presbyterian Hospital
New York City, New York, 10032
United States
Cook Children's Medical Center - Fort Worth
Ft. Worth, Texas, 76104
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
Women's and Children's Hospital
North Adelaide, South Australia, 5006
Australia
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
Madigan Army Medical Center
Tacoma, Washington, 98431-5000
United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54301
United States
Cardinal Glennon Children's Hospital
St. Louis, Missouri, 63104
United States
Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-2899
United States
Children's Hospital of Columbus
Columbus, Ohio, 43205-2696
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Primary Children's Medical Center
New York City, New York, 10029
United States
City of Hope National Medical Center
Duarte, California, 91010
United States
Royal Children's Hospital
Parkville, Victoria, 3052
Australia
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226
United States
Texas Children's Cancer Center
Houston, Texas, 77030-2399
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Princess Margaret Hospital for Children
Perth, Western Australia, 6001
Australia
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Children's Memorial Hospital - Chicago
Chicago, Illinois, 60614
United States
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
Canada
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
United States
Stanford University Medical Center
Stanford, California, 94305-5408
United States
Floating Hospital for Children
Boston, Massachusetts, 02111
United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78207
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Additional Information:
Study ID Numbers: CDR0000068760; COG-ADVL0015
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00021216
Other Unspecified Childhood Solid Tumor, Protocol Specific Studies:
1. BMS-214662 in Treating Patients With Solid Tumors
2. Oblimersen Plus Combination Chemotherapy and Dexrazoxane in Treating Children and Adolescents With Relapsed or Refractory Solid Tumors
3. Gemcitabine in Treating Children With Refractory Solid Tumors
4. Decitabine, Doxorubicin, and Cyclophosphamide in Treating Children With Relapsed or Refractory Solid Tumors or Neuroblastoma
5. Antibiotic Therapy With or Without G-CSF in Treating Children With Neutropenia and Fever Caused by Chemotherapy
Related Studies:
Other unspecified childhood solid tumor, protocol specific Clinical Trials
Other Quebec Clinical Trials
Other Montreal Clinical Trials
Bortezomib in Treating Children With Advanced Solid Tumors
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