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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00990912

Enrollment

Registered

2009-10-07

Start date

2004-01-31

Completion date

2005-11-30

Last updated

2010-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Solid Tumors

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.

Interventions

DRUGCarboplatin

IV, Infusion, AUC2 mg/ml.min, Once every 21 days, until progression or unacceptable toxicity

DRUGIrinotecan

IV, Infusion, 12 (9) mg/m²/day, Once daily x 10 days, every 21 days, until progression or unacceptable toxicity

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 18 Years

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)

Design outcomes

Primary

Measure	Time frame
Assessment of safety and tolerability	22 months

Secondary

Measure	Time frame
Assessment of duration of clinical benefit per CT or MRI, steroid use and neuropathy assessment	Every other cycle for 22 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026