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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


Phase 1/Phase 2
1 Year
18 Years
Not Enrolling
Both
Pediatric Solid Tumors

Thank you

Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assessment of safety and tolerability

Outcome Time Frame:

22 months

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study ID:

CA124-003

NCT ID:

NCT00990912

Start Date:

January 2004

Completion Date:

November 2005

Related Keywords:

  • Pediatric Solid Tumors
  • Neoplasms

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