Ignite Creation Date:
2024-05-05 @ 9:39 PM
Last Modification Date:
2024-10-26 @ 10:08 AM
Study NCT ID:
NCT00939770
Status:
COMPLETED
Last Update Posted:
2020-06-09
First Post:
2009-07-14
Brief Title:
Crizotinib in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase 12 Study of Crizotinib an Oral Small Molecule Inhibitor of Anaplastic Lymphoma Kinase ALK and C-Met in Children With RelapsedRefractory Solid Tumors and Anaplastic Large Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase 12 trial the studies side effects and best dose of crizotinib and to see how well it works in treating young patients with solid tumors or anaplastic large cell lymphoma that has returned after a period of improvement or does not respond to treatment Crizotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Phase 1 completed 21513
Detailed Description:
PRIMARY OBJECTIVES
I To estimate the maximum tolerated dose MTD and recommend a Phase 2 dose of Crizotinib administered orally twice daily to children with relapsedrefractory solid tumors and anaplastic large cell lymphoma ALCL completed 21513 II To define and describe the toxicities of Crizotinib administered on this schedule
III To characterize the pharmacokinetics of Crizotinib in children with refractory cancer
SECONDARY OBJECTIVES
I To preliminarily define the anti-tumor activity of Crizotinib within the confines of a Phase 1 study completed 21513 II To obtain initial Phase 2 data on the anti-tumor activity of Crizotinib in children with relapsedrefractory neuroblastoma and ALCL
III To preliminarily examine the relationship between anaplastic lymphoma kinase ALK status eg the presence of a mutation duplication amplification andor translocation in patients with neuroblastoma NB or ALCL and response to Crizotinib
IV To preliminarily examine the relationship between minimal residual disease MRD status and clinical response to Crizotinib in patients with ALCL
V To use a questionnaire to gather preliminary information on the palatability of the oral solution formulation of Crizotinib
VI To evaluate for potential alterations in bone growth in pediatric patients
OUTLINE This is a phase 1 dose-escalation study completed 21513 followed by a phase 2 study
Patients receive crizotinib orally PO twice daily BID on days 1-28 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up periodically
I To estimate the maximum tolerated dose MTD and recommend a Phase 2 dose of Crizotinib administered orally twice daily to children with relapsedrefractory solid tumors and anaplastic large cell lymphoma ALCL completed 21513 II To define and describe the toxicities of Crizotinib administered on this schedule
III To characterize the pharmacokinetics of Crizotinib in children with refractory cancer
SECONDARY OBJECTIVES
I To preliminarily define the anti-tumor activity of Crizotinib within the confines of a Phase 1 study completed 21513 II To obtain initial Phase 2 data on the anti-tumor activity of Crizotinib in children with relapsedrefractory neuroblastoma and ALCL
III To preliminarily examine the relationship between anaplastic lymphoma kinase ALK status eg the presence of a mutation duplication amplification andor translocation in patients with neuroblastoma NB or ALCL and response to Crizotinib
IV To preliminarily examine the relationship between minimal residual disease MRD status and clinical response to Crizotinib in patients with ALCL
V To use a questionnaire to gather preliminary information on the palatability of the oral solution formulation of Crizotinib
VI To evaluate for potential alterations in bone growth in pediatric patients
OUTLINE This is a phase 1 dose-escalation study completed 21513 followed by a phase 2 study
Patients receive crizotinib orally PO twice daily BID on days 1-28 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up periodically
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UM1CA097452 | NIH | CTEP | httpsreporternihgovquickSearchUM1CA097452 |
| NCI-2011-01937 | REGISTRY | None | None |
| P10666 | None | None | None |
| COG-ADVL0912 | None | None | None |
| CDR0000647587 | None | None | None |
| ADVL0912 | OTHER | None | None |
| ADVL0912 | OTHER | None | None |