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)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pediatric Solid Tumors

Intervention / Treatment
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* Drug: Carboplatin
* Drug: Irinotecan
* Drug: Irinotecan


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carboplatin<br> | Drug: Carboplatin<br>* IV, Infusion, AUC2 mg/ml.min, Once every 21 days, until progression or unacceptable toxicity<br>* Other names: BMY-26575;|
| Experimental: Irinotecan (12 (9) mg/m²/day)<br> | Drug: Irinotecan<br>* IV, Infusion, 12 (9) mg/m²/day, Once daily x 10 days, every 21 days, until progression or unacceptable toxicity<br>* Other names: Campto;|
| Active Comparator: Irinotecan (10 (10) mg/m²/day<br> | Drug: Irinotecan<br>* IV, Infusion, 10 (18) mg/m²/day, Once daily x 10 days, every 21 days, until progression or unacceptable toxicity<br>* Other names: Campto;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of safety and tolerability |  | 22 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of duration of clinical benefit per CT or MRI, steroid use and neuropathy assessment |  | Every other cycle for 22 months |