Rituximab in Metastatic Melanoma

Sponsor
Medical University of Vienna
Study ID
NCT01032122
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • rituximab — DRUG
    induction phase: 375mg/m² qw, 4wks; followed by maintenance phase: 375mg/m², every 8 wks; duration: 2 years.

Study Details

The purpose of this study is to determine whether rituximab as an adjuvant therapy in clinical stage IIIc / IV (no evidence of disease, AJCC (American Joint Committee on Cancer) 2002) melanoma patients is safe and prolongs overall survival and disease-free interval.

Key Dates

Start date
Oct 31, 2007
Status verified
Apr 2013
Primary completion
May 31, 2011
Completion
May 31, 2011

Study Design

Enrollment
9 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: rituximab

Primary Outcome Measure

disease-free interval [ Time Frame: 42 months ]

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