Expired Study
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Arcadia, California 91006


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.

Study summary:

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.


Inclusion Criteria: - 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 - Performance status - Karnofsky 50-100% (over 10 years of age) - Performance status - Lansky 50-100% (10 years of age and under) - At least 8 weeks - 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) - Bilirubin less than 1.5 mg/dL - ALT less than 5 times normal for age - Albumin at least 2 g/dL - Creatinine no greater than upper limit of normal for age - Creatinine clearance or radioisotope glomerular filtration rate greater than 70 mL/min - 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 - 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 - 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 - Concurrent dexamethasone allowed for CNS tumors if stable dose for at least 2 weeks - 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 - No prior bortezomib - No concurrent anticonvulsants - No other concurrent investigational agents



Primary Contact:

Principal Investigator
Susan Blaney
Children's Oncology Group

Backup Contact:


Location Contact:

Arcadia, California 91006
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 18, 2018

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