Unspecified Childhood Solid Tumor, Protocol SpecificPhase 1NCT00024284
Carboplatin and Irinotecan in Treating Children With Refractory Solid Tumors
A Phase 1 study testing carboplatin and irinotecan hydrochloride in people with Unspecified Childhood Solid Tumor, Protocol Specific, run by Bristol-Myers Squibb at 7 sites in 2 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of combining carboplatin and irinotecan in treating children who have refractory solid tumors. Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Unspecified Childhood Solid Tumor, Protocol Specific
- What is being tested?
- carboplatin and irinotecan hydrochloride
- How many people
- Not given
- Where
- 7 sitesin 2 countries
- Study dates
- Jun 2001to Dec 2003
- 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 1 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed solid tumor, including primary brain tumor
- Progressive disease on standard therapy or for which no standard therapy exists
- No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age:
- 1 to 21
Performance status:
- Lansky 50-100% (age 10 and under)
- Karnofsky 50-100% (over age 10)
Life expectancy:
- At least 8 weeks
Hematopoietic:
- Absolute neutrophil count greater than 1,000/mm3
- Platelet count greater than 100,000/mm3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- ALT no greater than 2.5 times upper limit of normal
Renal:
- Glomerular filtration rate at least 30 mL/min
Other:
- No active infection
- No serious uncontrolled medical disorder
- No psychiatric disorder or other disorder that would preclude study
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 6 months since prior allogeneic bone marrow transplantation without evidence of acute or chronic graft versus host disease
- At least 3 months since prior autologous bone marrow or peripheral blood stem cell transplantation
- At least 4 weeks since prior immunotherapy and recovered
- No concurrent immunotherapy
Chemotherapy:
- No more than 3 prior chemotherapy regimens
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- No other concurrent chemotherapy
Endocrine therapy:
- Concurrent hormone replacement therapy or oral contraceptives allowed
- No other concurrent hormonal therapy
Radiotherapy:
- At least 4 weeks since prior radiotherapy (including for brain metastases) and recovered
- No concurrent radiotherapy
Surgery:
- Not specified
Other:
- No other concurrent investigational anticancer drugs
- No other concurrent antitumor therapy
- No concurrent anticonvulsants (e.g., phenytoin, phenobarbital, or carbamazepine) except gabapentin (Neurontin)
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Washington University Medical Center
St Louis, Missouri, 63105
Arizona Cancer Center
Tucson, Arizona, 85724
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2916
About this study
Official title: A Phase I Study Of Carboplatin And Irinotecan In Patients 1-21 Years Of Age With Refractory Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of combining carboplatin and irinotecan in treating children who have refractory solid tumors.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose and recommended phase II dose of carboplatin and irinotecan in children with refractory solid tumors.
- Determine the safety profile and dose-limiting toxic effects of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the preliminary anti-tumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of carboplatin and irinotecan.
Patients receive carboplatin IV over 50 minutes on day 1 and irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of carboplatin and irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed for at least 30 days.
PROJECTED ACCRUAL: A total of 25-30 patients will be accrued for this study within 6-9 months.
- Being tested
- carboplatin, irinotecan hydrochloride
- Keywords
- unspecified childhood solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 startJun 2001
- Primary completionDec 2003
- Study completionDec 2003
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 Bristol-Myers SquibbThe 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
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Ashwin Gollerkeri, MD, Study chair, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00024284
- Sponsor's protocol ID
- CDR0000068908
- Other IDs
- BMS-CA124-001, CNMC-2782, MSKCC-01071, SJCRH-CARCPT, NCI-G01-2016
- Status last verified
- Apr 2013
- First submitted
- 13 Sep 2001
- Last updated
- 5 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Of Carboplatin And Irinotecan In Patients 1-21 Years Of Age With Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT00024284
- Acronym / sponsor ID
- CDR0000068908
- Keywords
- unspecified childhood solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2001
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of combining carboplatin and irinotecan in treating children who have refractory solid tumors.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose and recommended phase II dose of carboplatin and irinotecan in children with refractory solid tumors.
- Determine the safety profile and dose-limiting toxic effects of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the preliminary anti-tumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of carboplatin and irinotecan.
Patients receive carboplatin IV over 50 minutes on day 1 and irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of carboplatin and irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed for at least 30 days.
PROJECTED ACCRUAL: A total of 25-30 patients will be accrued for this study within 6-9 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| carboplatin | Drug | – |
| irinotecan hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
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 5 Apr 2013.
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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.
Ashwin Gollerkeri, MD study chair
Bristol-Myers Squibb
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing carboplatin and irinotecan hydrochloride in people with Unspecified Childhood Solid Tumor, Protocol Specific, run by Bristol-Myers Squibb at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 5 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. 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.
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 5 Apr 2013.