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Leukine vs Saline for Early-stage Melanoma
NCT01826864Phase 3
Key facts
- Status
- Withdrawn
- Start
- Aug 2011
- Primary completion
- Aug 2017
- Countries
- 1
- Sponsor
- UCLA Jonsson Comprehensive Cancer Center
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- sargramostim
- Conditions
- melanoma
01
Overview
Phase 3, randomised trial of sargramostim in melanoma (2 arms), sponsored by UCLA Jonsson Comprehensive Cancer Center. Primary endpoints: Reversal of alterations in the sentinel lymph nodes at 30 days and Proportion of subjects with positive sentinel lymph nodes at 30 days. Planned start Aug 2011; status: withdrawn.
02
Design
2 arms- Study design
- Randomized
Sargramostim
Sargramostim SC 3-5 days prior to SLNB
Hypertonic Saline
Hypertonic saline SC 3-5 days prior to SLNB
03
Who it enrols
Patients with stage IB or II cutaneous melanoma on the torso, extremities, or head and neck, with no evidence of metastasis.
04
Endpoints
Primary
Reversal of alterations in the sentinel lymph nodes
Proportion of subjects with positive sentinel lymph nodes
Secondary
Disease Free Survival
Overall Survival
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