Pediatric Solid TumorsPhase 1/2NCT00990912
A Study to Document Long-Term Safety and Continued Benefit of Irinotecan and Carboplatin or Irinotecan in Subjects With Refractory Solid Tumors (Rollover Study -001, -002)
A Phase 1/2 study testing Carboplatin and Irinotecan in people with Pediatric Solid Tumors, run by Bristol-Myers Squibb.
Trial summary
The purpose of this study is to determine the long term safety of patients with refractory solid tumors who have experienced clinical benefit after at least 6 cycles of treatment in BMS Protocol CA124-001 or CA124-002. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Pediatric Solid Tumors
- What is being tested?
- Carboplatin and Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Nov 2005
- Phase
- Phase 1/2
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Completion of at least 6 cycles of therapy on BMS clinical protocol CA124-001 or CA124-002 and who continue to derive clinical benefit and are not experiencing intolerable toxicity from the therapy
- Karnofsky score of at least 50 for subjects > 10 years of age; Lansky play scale of at least 50 for children 10 years of age and younger
- Recovery to baseline or Grade 1 from toxicities (except alopecia or asthenia) resulting from previous therapies
- Males and females, ages 1 - 21 years of age at the time of consent into CA124-001 or CA124-002
Who cannot join
- A serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy
- Requirement to receive concurrent chemotherapy, immunotherapy, radiotherapy, or any other investigational drug while on study
- Inadequate bone marrow and renal function
- Concurrent receipt of Dilantin®(phenytoin), phenobarbital, primidone, Tegretol®(carbamazepine), Depacon®, Depakene®, Depakote®, and Deproic®(valproic acid)
About this study
Official title: A Study to Document Long-term Safety and Continued Benefit of Irinotecan and Carboplatin or Irinotecan in Subjects 1 - 21 Years of Age With Refractory Solid Tumors Who Have Experienced Clinical Benefit Following a Minimum of 6 Cycles of Therapy on BMS Protocol CA124-001 or BMS Protocol CA124-002
The purpose of this study is to determine the long term safety of patients with refractory solid tumors who have experienced clinical benefit after at least 6 cycles of treatment in BMS Protocol CA124-001 or CA124-002.
- Conditions
- Pediatric Solid Tumors
- Being tested
- Carboplatin, Irinotecan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
Also called Paraplatin, BMY-26575
IV, Infusion, AUC2 mg/ml.min, Once every 21 days, until progression or unacceptable toxicity
IrinotecanDrug
Also called Camptosar, Campto
IV, Infusion, 12 (9) mg/m²/day, Once daily x 10 days, every 21 days, until progression or unacceptable toxicity
IrinotecanDrug
Also called Camptosar, Campto
IV, Infusion, 10 (18) mg/m²/day, Once daily x 10 days, every 21 days, until progression or unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| Carboplatin | Experimental | Not described Receives: Drug: Carboplatin |
| Irinotecan (12 (9) mg/m²/day) | Experimental | Not described Receives: Drug: Irinotecan |
| Irinotecan (10 (10) mg/m²/day | Active comparator | Not described Receives: Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of safety and tolerability
Measured: 22 months
Secondary outcomes (1)
Assessment of duration of clinical benefit per CT or MRI, steroid use and neuropathy assessment
Measured: Every other cycle for 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startJan 2004
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Solid TumorsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990912
- Sponsor's protocol ID
- CA124-003
- Status last verified
- Oct 2009
- First submitted
- 5 Oct 2009
- Last updated
- 5 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Document Long-term Safety and Continued Benefit of Irinotecan and Carboplatin or Irinotecan in Subjects 1 - 21 Years of Age With Refractory Solid Tumors Who Have Experienced Clinical Benefit Following a Minimum of 6 Cycles of Therapy on BMS Protocol CA124-001 or BMS Protocol CA124-002
- ClinicalTrials.gov ID
- NCT00990912
- Acronym / sponsor ID
- CA124-003
- Conditions
- Pediatric Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 7 Oct 2009 (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.
The purpose of this study is to determine the long term safety of patients with refractory solid tumors who have experienced clinical benefit after at least 6 cycles of treatment in BMS Protocol CA124-001 or CA124-002.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Carboplatin | Experimental | Drug: Carboplatin |
| Irinotecan (12 (9) mg/m²/day) | Experimental | Drug: Irinotecan |
| Irinotecan (10 (10) mg/m²/day | Active comparator | Drug: Irinotecan |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Completion of at least 6 cycles of therapy on BMS clinical protocol CA124-001 or CA124-002 and who continue to derive clinical benefit and are not experiencing intolerable toxicity from the therapy
- Karnofsky score of at least 50 for subjects > 10 years of age; Lansky play scale of at least 50 for children 10 years of age and younger
- Recovery to baseline or Grade 1 from toxicities (except alopecia or asthenia) resulting from previous therapies
- Males and females, ages 1 - 21 years of age at the time of consent into CA124-001 or CA124-002
Key exclusion criteria (4 listed)
- A serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy
- Requirement to receive concurrent chemotherapy, immunotherapy, radiotherapy, or any other investigational drug while on study
- Inadequate bone marrow and renal function
- Concurrent receipt of Dilantin®(phenytoin), phenobarbital, primidone, Tegretol®(carbamazepine), Depacon®, Depakene®, Depakote®, and Deproic®(valproic acid)
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 |
|---|---|---|
| CarboplatinAlso: Paraplatin, BMY-26575IV, Infusion, AUC2 mg/ml.min, Once every 21 days, until progression or unacceptable toxicity | Drug | Carboplatin |
| IrinotecanAlso: Camptosar, CamptoIV, Infusion, 12 (9) mg/m²/day, Once daily x 10 days, every 21 days, until progression or unacceptable toxicity | Drug | Irinotecan (12 (9) mg/m²/day) |
| IrinotecanAlso: Camptosar, CamptoIV, Infusion, 10 (18) mg/m²/day, Once daily x 10 days, every 21 days, until progression or unacceptable toxicity | Drug | Irinotecan (10 (10) mg/m²/day |
Primary outcome
Assessment of safety and tolerability
Time frame: 22 months
1 secondary outcome
Assessment of duration of clinical benefit per CT or MRI, steroid use and neuropathy assessment
Time frame: Every other cycle for 22 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 5 Feb 2010.
Related trials for Pediatric Solid Tumors
RecruitingPhase 1
A Study of Codrituzumab in Children and Young Adults With Solid Tumors and Have Not Responded to Treatment or Have Come Back After Treatment
Primary Extra-cranial Solid Tumor, Recurrent or Refractory Glypican 3 (GPC3)
RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
RecruitingObservational study
Natural History and Biospecimen Acquisition for Children and Adults With Rare Solid Tumors
Malignant Solid Tumors, Other Neoplasms Solid Tumors
RecruitingPhase 2
A Study of Selinexor in People With Wilms Tumors and Other Solid Tumors
Wilms Tumor, Rhabdoid Tumor
Not yet recruitingPhase 2
Mirdametinib to Reduce the Size of Large/Giant Congenital Melanocytic Nevi in Children, Adolescents and Young Adults
LGCMN, Large and Giant Congenital Melanocytic Nevi
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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Carboplatin and Irinotecan in people with Pediatric Solid Tumors, run by Bristol-Myers Squibb.
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 4 inclusion and 4 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 5 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Assessment of safety and tolerability (time frame: 22 months). 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 5 Feb 2010.