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

NCT ID: NCT02494206

Last Updated: 2018-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2018-05-31

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.

Conditions

Breast Cancer; Upper Extremity Lymphedema

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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).

Group Type: EXPERIMENTAL

QBX258

Intervention Type: DRUG

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.

Interventions

QBX258

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.

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Babak Mehara, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

15-085

Identifier Type: -

Identifier Source: org_study_id