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Rituximab in Metastatic Melanoma

Primary Purpose

Metastatic Melanoma

Status

Terminated

Phase

Phase 1

Locations

Austria

Study Type

Interventional

Intervention

rituximab

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

NCT ID

NCT01032122

First Posted

September 19, 2009

Last Updated

April 24, 2013

Sponsor

Medical University of Vienna

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

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

Learn more about this trial

Rituximab in Metastatic Melanoma

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