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Completed

NCT Number: NCT00990912

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)

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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Key information

Conditions

Pediatric Solid Tumors

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

carboplatin

Drug

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

Other names: Paraplatin, BMY-26575

Irinotecan

Drug

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

Other names: Camptosar, Campto

Primary outcomes

  1. Assessment of safety and tolerability

    Time frame: 22 months

Secondary outcomes

  1. Assessment of duration of clinical benefit per CT or MRI, steroid use and neuropathy assessment

    Time frame: Every other cycle for 22 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Oct 7, 2009
Registry last updated
Feb 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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