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)

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Pediatric Solid Tumors

Treatments

Drug: Carboplatin

Drug: Irinotecan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00990912

CA124-003

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

1 to 18 years old

Volunteers

No Healthy Volunteers

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

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)