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

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)

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0 participants in 2 patient groups

Arm A

Experimental group

Treatment:

Drug: carboplatin + irinotecan

Arm B

Active Comparator group

Treatment:

Drug: irinotecan