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 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
1 other identifier
interventional
20
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2004
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 5, 2009
CompletedFirst Posted
Study publicly available on registry
October 7, 2009
CompletedFebruary 5, 2010
October 1, 2009
1.8 years
October 5, 2009
February 3, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of safety and tolerability
22 months
Secondary Outcomes (1)
Assessment of duration of clinical benefit per CT or MRI, steroid use and neuropathy assessment
Every other cycle for 22 months
Study Arms (3)
Carboplatin
EXPERIMENTALIrinotecan (12 (9) mg/m²/day)
EXPERIMENTALIrinotecan (10 (10) mg/m²/day
ACTIVE COMPARATORInterventions
IV, Infusion, AUC2 mg/ml.min, Once every 21 days, until progression or unacceptable toxicity
IV, Infusion, 12 (9) mg/m²/day, Once daily x 10 days, every 21 days, until progression or unacceptable toxicity
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 5, 2009
First Posted
October 7, 2009
Study Start
January 1, 2004
Primary Completion
November 1, 2005
Study Completion
November 1, 2005
Last Updated
February 5, 2010
Record last verified: 2009-10