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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2005-11-30

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.

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Detailed Description

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Conditions

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Pediatric Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Carboplatin

Group Type EXPERIMENTAL

Carboplatin

Intervention Type DRUG

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

Irinotecan (12 (9) mg/m²/day)

Group Type EXPERIMENTAL

Irinotecan

Intervention Type DRUG

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

Irinotecan (10 (10) mg/m²/day

Group Type ACTIVE_COMPARATOR

Irinotecan

Intervention Type DRUG

IV, Infusion, 10 (18) mg/m²/day, Once daily x 10 days, every 21 days, until progression or unacceptable toxicity

Interventions

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Carboplatin

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

Intervention Type DRUG

Irinotecan

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

Intervention Type DRUG

Irinotecan

IV, Infusion, 10 (18) mg/m²/day, Once daily x 10 days, every 21 days, until progression or unacceptable toxicity

Intervention Type DRUG

Other Intervention Names

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Paraplatin BMY-26575 Camptosar Campto Camptosar Campto

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)

Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No