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)

Phase 1

Completed

• Conditions: Pediatric Solid Tumors
• Interventions: Drug: Irinotecan; Drug: Carboplatin

• Registration Number: NCT00990912
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Status Verified: 2009-10
• Study First Submitted: 2009-10-05
• Study First Submitted QC: 2009-10-06
• Study First Posted: 2009-10-07
• Disposition First Submitted: 2010-02-03
• Disposition First Submitted QC: 2010-02-03
• Last Update Submitted: 2010-02-03
• Disposition First Posted: 2010-02-05
• Last Update Posted: 2010-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Irinotecan (10 (10) mg/m²/day	Irinotecan	-
Irinotecan (12 (9) mg/m²/day)	Irinotecan	-
Carboplatin	Carboplatin	-

Primary Outcome Measures

Name	Time	Method
Assessment of safety and tolerability	22 months

Secondary Outcome Measures

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