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

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.

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Key information

Conditions

Neoplasms

Age range

1 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Orlando, Florida, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

carboplatin + irinotecan

Drug

Solution, IV, Carbopaltin AUC 4 mg/ml.min every 21 days; irinotecan 12 mg/m2/day x 10 days , Minimum of two cycles of chemotherapy projected to be up to 6.

Other names: Paraplatin

Irinotecan

Drug

Solution, IV, irinotecan 12 mg/m2/day x 10 days, minimum of two cycles of chemotherapy projected to be up to 6.

Primary outcomes

estimate response rate

Secondary outcomes

evaluate safety

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start: 2003
Primary completion: 2004
Study completion: 2004
First posted: Apr 3, 2003
Registry last updated: Apr 14, 2011

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.

Published trials that share one or more normalized conditions with this study.

Completed