Unspecified Childhood Solid Tumor, Protocol SpecificPhase 1NCT00021216
Bortezomib in Treating Children With Advanced Solid Tumors
A Phase 1 study testing bortezomib, laboratory biomarker analysis and pharmacological study in people with Unspecified Childhood Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Unspecified Childhood Solid Tumor, Protocol Specific
- What is being tested?
- bortezomib, laboratory biomarker analysis and pharmacological study
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to Dec 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
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- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Oncology Group
Arcadia, California, 91006-3776
About this study
Official title: A Phase I Study Of PS-341 In Pediatric Patients With Refractory Solid Tumors
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Being tested
- bortezomib, laboratory biomarker analysis, pharmacological study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bortezomibDrug
Also called LDP 341, MLN341, VELCADE
Given IV
laboratory biomarker analysisOther
Correlative studies
Also called pharmacological studies
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (bortezomib) | Experimental | 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. Receives: Drug: bortezomib; Other: laboratory biomarker analysis; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD defined as the dose at which fewer than 20% of patients experience DLT assessed using CTC version 2.0
Measured: 3 weeks
20S proteasome inhibition
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.
Measured: Up to 2 weeks
Progression free survival
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startNov 2001
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Childhood Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Susan Blaney, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00021216
- Sponsor's protocol ID
- NCI-2012-01860
- Other IDs
- NCI-2012-01860, COG-ADVL0015, CDR0000068760, ADVL0015, ADVL0015, U01CA097452
- Status last verified
- Dec 2013
- First submitted
- 11 Jul 2001
- Last updated
- 15 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Of PS-341 In Pediatric Patients With Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT00021216
- Acronym / sponsor ID
- NCI-2012-01860
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Nov 2001
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (bortezomib) | Experimental | Drug: bortezomib, Other: laboratory biomarker analysis, Other: pharmacological studyPatients receive bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (41 listed)
- Histologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy exists
- Ineligible for therapies of higher priority
- Stratum II only:
- Performance status - Karnofsky 50-100% (over 10 years of age)
- Performance status - Lansky 50-100% (10 years of age and under)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bortezomibAlso: LDP 341, MLN341, VELCADEGiven IV | Drug | Treatment (bortezomib) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (bortezomib) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Treatment (bortezomib) |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Blaney principal investigator
Children's Oncology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing bortezomib, laboratory biomarker analysis and pharmacological study in people with Unspecified Childhood Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 41 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD defined as the dose at which fewer than 20% of patients experience DLT assessed using CTC version 2.0 (time frame: 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2015.