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NCT01032122 Clinical Trial

Rituximab in Metastatic Melanoma

Metastatic Melanoma Clinical Trial

Official title:
Efficacy and Safety of Rituximab, an Anti-CD20 (Cluster of Differentiation Antigen 20) Therapeutic Agent, in Metastatic Melanoma: a Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01032122
Other study ID # MIMM1
Secondary ID
Status Terminated
Phase Phase 1
First received September 19, 2009
Last updated April 24, 2013
Start date October 2007
Est. completion date May 2011

Study information
Verified date April 2013
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Agency for Health and Food Safety
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 9
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Histologically verified non-ocular melanoma stage IIIc/IV, no evidence of disease

Exclusion Criteria:

- 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Austria General Hospital Vienna, Dep. of Dermatology, Division of Immunology and Infectious Diseases Vienna

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary disease-free interval 42 months No
Secondary overall survival 42 months No
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