Study Stopped
the only reason is that recruitment was not sufficient to meet the planned patient numbers, because complete remissions are still infrequent.
Rituximab in Metastatic Melanoma
Efficacy and Safety of Rituximab, an Anti-CD20 (Cluster of Differentiation Antigen 20) Therapeutic Agent, in Metastatic Melanoma: a Pilot Study
1 other identifier
interventional
9
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2007
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 19, 2009
CompletedFirst Posted
Study publicly available on registry
December 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedApril 25, 2013
April 1, 2013
3.6 years
September 19, 2009
April 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
disease-free interval
42 months
Secondary Outcomes (1)
overall survival
42 months
Study Arms (1)
rituximab
EXPERIMENTALInterventions
induction phase: 375mg/m² qw, 4wks; followed by maintenance phase: 375mg/m², every 8 wks; duration: 2 years.
Eligibility Criteria
You may qualify if:
- Histologically verified non-ocular melanoma stage IIIc/IV, no evidence of disease
You may not qualify if:
- ECOG (Eastern Cooperative Oncology Group) performance status \> 2
- Ocular melanoma
- Immunodeficiency syndromes or hypogammaglobulinaemia
- Active autoimmune diseases
- Treatment with immunosuppressive agents other than steroids
- Depressed bone marrow function (Leukopenia \<3000, platelet count \<100.000)
- Cardiac insufficiency NYHA (New York Heart Association) IV
- active Hepatitis B,C, or HIV infection
- Pregnancy or lactation
- Interstitial pulmonary disease
- Former treatment with anti-CD20 antibody
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
General Hospital Vienna, Dep. of Dermatology, Division of Immunology and Infectious Diseases
Vienna, 1090, Austria
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephan Wagner, MD
Med Univ Vienna
- PRINCIPAL INVESTIGATOR
Alice Pinc, MD
Medical Univ Vienna
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
September 19, 2009
First Posted
December 15, 2009
Study Start
October 1, 2007
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
April 25, 2013
Record last verified: 2013-04