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A Phase II Study of Carboplatin Plus Irinotecan Versus Irinotecan in Children With Refractory Solid Tumors

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 2

Conditions

Neoplasms

Treatments

Drug: irinotecan
Drug: carboplatin + irinotecan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00057473
CA124-002

Details and patient eligibility

About

This clinical research study is being conducted to investigate the effectiveness of combining carboplatin and irinotecan, versus irinotecan alone, in treating children who have refractory solid tumors.

Sex

All

Ages

1 to 21 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

  • children 1-21 years of age
  • confirmed diagnosis of measurable solid tumor, including brain tumor, which has progressed on or after standard therapy, or for which no effective standard therapy is known
  • at least 4 weeks since last dose of immunotherapy, radiotherapy, or chemotherapy
  • no more than 3 prior chemotherapies
  • no symptomatic brain metastases

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Arm A
Experimental group
Treatment:
Drug: carboplatin + irinotecan
Arm B
Active Comparator group
Treatment:
Drug: irinotecan

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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