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Doxorubicin and Interleukin-2 in Unresectable Hepatocellular Carcinoma
NCT00004248Phase 2
Key facts
- Status
- Completed
- Start
- Jul 1999
- Primary completion
- Jun 2000
- Countries
- 1
- Modality
- DNA Intercalators/Alkylators, Cytokines & Interferons
- Conditions
- hepatocellular carcinoma (HCC)
01
Overview
Phase 2, open-label, single-arm trial of aldesleukin and doxorubicin in hepatocellular carcinoma (HCC), sponsored by Roswell Park Comprehensive Cancer Center. Primary endpoint: Immunological response (hepatocellular carcinoma specific cytotoxic T cells). Started Jul 1999; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Doxorubicin + Aldesleukin
Low dose doxorubicin and protracted infusion of recombinant interleukin-2
03
Who it enrols
Adults with unresectable hepatocellular carcinoma, ECOG 0-2, adequate organ function, no prior doxorubicin, and no severe cardiac disease.
04
Endpoints
Primary
Immunological response (hepatocellular carcinoma specific cytotoxic T cells)
Secondary
Toxicity
Tumor response
Progression-Free Survival
Overall Survival
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