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

Primary Purpose

Breast Cancer, Upper Extremity Lymphedema

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
QBX258
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring QBX258, human monoclonal antibodies, VAK694, QAX576, 15-085

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • BMI of 18-30
  • No current evidence of breast cancer
  • At least 6 months postop from axillary lymph node dissection

Exclusion Criteria:

  • Bilateral lymphedema or history of bilateral axillary lymph node dissection
  • Recent history of cellulitis in the affected extremity (within last 3 months)
  • Recurrent breast cancer or other malignancy
  • Current (within last month) use of chemotherapy for breast or other malignancy
  • Current (within last 3 months) use of radiation for breast or other malignancy
  • Recent (within last month) or current intensive MLD and/or short stretch bandage use
  • Unstable lymphedema (i.e. worsening symptoms/measurements in the past 3 months)
  • Pregnant or nursing (lactating) women
  • Stage III lymphedema
  • Patients that take acetaminophen (paracetamol) chronically, i.e. more than 1 g/day for more than 3 out of 7 days, or more than 2 g/ day for more than 1 day out of 7 days
  • Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
  • History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes (e.g. monoclonal antibodies, polyclonal gamma globulin, polysorbates).

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 7, 2015
Last Updated
October 10, 2018
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT02494206
Brief Title
Immunotherapy for the Treatment of Breast Cancer Related Upper Extremity Lymphedema (BCRL)
Official Title
Immunotherapy for the Treatment of Breast Cancer Related Upper Extremity Lymphedema (BCRL)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Novartis

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to assess the efficacy of QBX258, a compound developed by Novartis Corporation composed of two antibodies, in reducing arm volume excess in women with stage I-II breast cancer related lymphedema.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Upper Extremity Lymphedema
Keywords
QBX258, human monoclonal antibodies, VAK694, QAX576, 15-085

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
QBX258 (VAK694 3mg/kg and QAX576 6mg/kg)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
QBX258
Intervention Description
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.
Primary Outcome Measure Information:
Title
Volume Changes as Measured by Perometry
Description
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
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 BMI of 18-30 No current evidence of breast cancer At least 6 months postop from axillary lymph node dissection Exclusion Criteria: Bilateral lymphedema or history of bilateral axillary lymph node dissection Recent history of cellulitis in the affected extremity (within last 3 months) Recurrent breast cancer or other malignancy Current (within last month) use of chemotherapy for breast or other malignancy Current (within last 3 months) use of radiation for breast or other malignancy Recent (within last month) or current intensive MLD and/or short stretch bandage use Unstable lymphedema (i.e. worsening symptoms/measurements in the past 3 months) Pregnant or nursing (lactating) women Stage III lymphedema Patients that take acetaminophen (paracetamol) chronically, i.e. more than 1 g/day for more than 3 out of 7 days, or more than 2 g/ day for more than 1 day out of 7 days Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes (e.g. monoclonal antibodies, polyclonal gamma globulin, polysorbates).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Babak Mehara, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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