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Rituximab in Metastatic Melanoma

Primary Purpose

Metastatic Melanoma

Status
Terminated
Phase
Phase 1
Locations
Austria
Study Type
Interventional
Intervention
rituximab
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Melanoma focused on measuring melanoma, rituximab, metastatic, stage IIIc/IV, stem cell, overall survival, disease free interval, anti-CD20 therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • General Hospital Vienna, Dep. of Dermatology, Division of Immunology and Infectious Diseases

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

rituximab

Arm Description

Outcomes

Primary Outcome Measures

disease-free interval

Secondary Outcome Measures

overall survival

Full Information

First Posted
September 19, 2009
Last Updated
April 24, 2013
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01032122
Brief Title
Rituximab in Metastatic Melanoma
Official Title
Efficacy and Safety of Rituximab, an Anti-CD20 (Cluster of Differentiation Antigen 20) Therapeutic Agent, in Metastatic Melanoma: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Terminated
Why Stopped
the only reason is that recruitment was not sufficient to meet the planned patient numbers, because complete remissions are still infrequent.
Study Start Date
October 2007 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Melanoma
Keywords
melanoma, rituximab, metastatic, stage IIIc/IV, stem cell, overall survival, disease free interval, anti-CD20 therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rituximab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
rituximab
Other Intervention Name(s)
mabthera, rituxan
Intervention Description
induction phase: 375mg/m² qw, 4wks; followed by maintenance phase: 375mg/m², every 8 wks; duration: 2 years.
Primary Outcome Measure Information:
Title
disease-free interval
Time Frame
42 months
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
42 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Wagner, MD
Organizational Affiliation
Med Univ Vienna
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alice Pinc, MD
Organizational Affiliation
Medical Univ Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital Vienna, Dep. of Dermatology, Division of Immunology and Infectious Diseases
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

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Rituximab in Metastatic Melanoma

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