Clinical trial · Interventional
Bortezomib in Treating Children With Advanced Solid Tumors
A Phase I Study Of PS-341 In Pediatric Patients With Refractory Solid Tumors
NCT00021216CI-TRIAL-00017522completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (bortezomib)
- description
- 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.
- interventionNames
- Drug: bortezomib
- Other: laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (3)
- measure
- MTD defined as the dose at which fewer than 20% of patients experience DLT assessed using CTC version 2.0
- timeFrame
- 3 weeks
- measure
- 20S proteasome inhibition
- timeFrame
- Up to 2 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.