None listed
Conditions
Interventions
Carboplatin plus Irinotecan Type of group
Carboplatin 4 mg / ml will be given every 21 days plus Irinotecan 12 mg / m2 / day every 21 days. in patients with refractory tumors of the central nervous system (CNS) and others who are non-CNS.
Group name:Irinotecan Type of group
Irinotecan 20 mg / m2 / day will be administered every 21 days. In patients with refractory tumors of the central nervous system (CNS) and others that are non-CNS.
Sponsors
BRISTOL MYERS SQUIBB PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 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 criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Response rate using the RECIST criteria. In patients with primary CNS tumors, the response rate will be evaluated based on tumor measurements, the spheroid dependence on; part of the patient, and the neurological evaluation. Measure:Clinical activity of the combination of carboplatin plus Irinotecan, and of irinotecan as a single agent, through an estimated response rate in patients suffering from refractory central nervous system (CNS) tumors and others who are non-CNS. Timepoints:30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The degrees of worst toxicity for serious adverse events (EAS), for adverse events (AD) and for abnormal laboratory parameters will be tabulated by patient. Measure:Safety profile of the combination of carboplatin plus irlnotecan, and Irinotecan as a single agent, in patients between 1 and 21 years of age. Timepoints:30 days | — |
Countries
Peru, United States
Outcome results
None listed