Status:
COMPLETED
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)
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Pediatric Solid Tumors
Eligibility:
All Genders
1-18 years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00990912
Start Date
January 1 2004
End Date
November 1 2005
Last Update
February 5 2010
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