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)
- Conditions
- C969-C96 Other and unspecified malignant neoplasms of lymphoid, haematopoietic and related tissueOther and unspecified malignant neoplasms of lymphoid, haematopoietic and related tissueOther specified malignant neoplasms of lymphoid, haematopoietic and related tissueMalignant neoplasm of lymphoid, haematopoietic and related tissue, unspecifiedC96C967
- Registration Number
- PER-031-03
- Lead Sponsor
- BRISTOL MYERS SQUIBB PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method