Bortezomib in Treating Children With Advanced Solid Tumors
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ClinicalTrials.gov Identifier: NCT00021216 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : April 15, 2015
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Condition or disease | Intervention/treatment | Phase |
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Unspecified Childhood Solid Tumor, Protocol Specific | Drug: bortezomib Other: laboratory biomarker analysis Other: pharmacological study | Phase 1 |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Study Of PS-341 In Pediatric Patients With Refractory Solid Tumors |
Study Start Date : | November 2001 |
Actual Primary Completion Date : | December 2005 |
Actual Study Completion Date : | December 2005 |

Arm | Intervention/treatment |
---|---|
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.
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Drug: bortezomib
Given IV
Other Names:
Other: laboratory biomarker analysis Correlative studies Other: pharmacological study Correlative studies
Other Name: pharmacological studies |
- MTD defined as the dose at which fewer than 20% of patients experience DLT assessed using CTC version 2.0 [ Time Frame: 3 weeks ]
- 20S proteasome inhibition [ Time Frame: Up to 2 weeks ]The 95% confidence interval for the percent of patients who exhibit inhibition at a recommended dose level determined according to the table above is 61%-100%, if six patients are evaluated or 55%-100% if five patients are evaluated.
- Progression free survival [ Time Frame: Up to 24 months ]

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Ages Eligible for Study: | up to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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
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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
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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
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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
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Stratum II only:
- No prior radiotherapy to more than 20% of bone marrow
- No prior bortezomib
- No concurrent anticonvulsants
- No other concurrent investigational agents

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00021216
United States, California | |
Children's Oncology Group | |
Arcadia, California, United States, 91006-3776 |
Principal Investigator: | Susan Blaney | Children's Oncology Group |
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00021216 |
Other Study ID Numbers: |
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 ) |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | April 15, 2015 |
Last Verified: | December 2013 |
Neoplasms Bortezomib Antineoplastic Agents |