Rituximab in Metastatic Melanoma | NCT01032122

Studies
Rituximab in Metastatic Melanoma

NCT01032122

Sponsor

Medical University of Vienna

Status

Terminated

Last Update Posted

Apr 25, 2013Estimated

Enrollment

9Actual

Phase

Phase 1

Conditions

Metastatic Melanoma

Interventions

rituximab

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

the only reason is that recruitment was not sufficient to meet the planned patient numbers, because complete remissions are still infrequent.

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Sep 19, 2009

First Submission Date that Met QC Criteria

Dec 14, 2009

First Posted Date

Dec 15, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2013

Last Update Posted Date

Apr 25, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stephan N. Wagner, MD, MD, Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
rituximab	Experimental		Drug: rituximab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rituximab	Drug	induction phase: 375mg/m² qw, 4wks; followed by maintenance phase: 375mg/m², every 8 wks; duration: 2 years.	rituximab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
disease-free interval		42 months

Secondary Outcomes

Measure	Description	Time Frame
overall survival		42 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephan Wagner, MD	Med Univ Vienna	Principal Investigator
Alice Pinc, MD	Medical Univ Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
General Hospital Vienna, Dep. of Dermatology, Division of Immunology and Infectious Diseases		Vienna		1090	Austria

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma
D009362	Neoplasm Metastasis

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069283	Rituximab

Ancestor Terms

ID	Term
D058846	Antibodies, Monoclonal, Murine-Derived
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided