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

Bristol-Myers Squibb

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Neoplasms

Interventions

carboplatin + irinotecanDRUG

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.

irinotecanDRUG

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

Eligibility

Sex: ALLMin age: 1 YearMax age: 21 Years

Medical Language ↔ Plain English

* 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

Locations (2)

Local Institution

Orlando, Florida, United States

Local Institution

Houston, Texas, United States

Outcomes

Primary Outcomes

estimate response rate

Secondary Outcomes

evaluate safety

Data from ClinicalTrials.gov

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