Bortezomib in Treating Children With Advanced Solid Tumors
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: bortezomib Other: laboratory biomarker analysis Other: pharmacological study |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study Of PS-341 In Pediatric Patients With Refractory Solid Tumors |
- MTD defined as the dose at which fewer than 20% of patients experience DLT assessed using CTC version 2.0 [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
- 20S proteasome inhibition [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 36 |
| Study Start Date: | November 2001 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: bortezomib
Given IV
Other Names:
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00021216 History of Changes |
| Other Study ID Numbers: | NCI-2012-01860, ADVL0015, U01CA097452, CDR0000068760 |
| Study First Received: | July 11, 2001 |
| Last Updated: | May 3, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms Bortezomib Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013