Trials Sponsors Conditions Drugs Pricing

Conditions

Breast Cancer Upper Extremity Lymphedema

Keywords

QBX258human monoclonal antibodiesVAK694QAX57615-085

Outcome Measures

Primary Outcomes (1)

Volume Changes as Measured by Perometry
Therapeutic volume changes in the arm will be calculated using the methods published by Anderson et al (2000).65 Briefly, the difference in volume measurements between the normal and lymphedematous arms at baseline (i.e volume excess) will be compared to the volume differential after drug treatment and following the washout period using the following formula: (VL-VN) B - (VL-VN) F
1 year

Study Arms (1)

QBX258 (VAK694 3mg/kg and QAX576 6mg/kg)

EXPERIMENTAL

This will be a single arm, open label design pilot study, aiming to test the efficacy of QBX258, a combination of two fully human monoclonal antibodies that neutralize the biologic activity of interleukin 4 and interleukin 13 (IL4/IL13), for the treatment of stage I or II breast cancer related upper extremity lymphedema (BCRL).

Drug: QBX258

Interventions

QBX258Drug

Once patients are registered for the trial, they will be treated with QBX258 (VAK694 3mg/kg and QAX576 6mg/kg) delivered via peripheral intravenous injection once every 4 weeks (+ 1 week) for 4 treatments.

QBX258 (VAK694 3mg/kg and QAX576 6mg/kg)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 70 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Women 18-70 with unilateral stage I or II BCRL
Volume difference of at least 300 mL between the normal and lymphedematous limb based on perometry evaluation

Sponsors & Collaborators

Memorial Sloan Kettering Cancer Center
Otherlead
Novartis
Industrycollaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title: Dr. Babak Mehrara MD
Organization: Memorial Sloan Kettering Cancer Center

Study Officials

Babak Mehara, MD
Memorial Sloan Kettering Cancer Center
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

9 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 7, 2015

First Posted

July 10, 2015

Study Start

July 2015

Actual (reported)

Primary Completion

Immunotherapy for the Treatment of Breast Cancer Related Upper Extremity Lymphedema (BCRL)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

QBX258 (VAK694 3mg/kg and QAX576 6mg/kg)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

QBX258 (VAK694 3mg/kg and QAX576 6mg/kg)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations