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

NCT02494206 | Completed Results

• 1 other identifier: 15-085
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Keywords

QBX258; human monoclonal antibodies; VAK694; QAX576; 15-085

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

QBX258 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.

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (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
• BMI of 18-30
• No current evidence of breast cancer
• At least 6 months postop from axillary lymph node dissection

You may not qualify if:

• 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).

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Novartis: collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

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

mehrarab@mskcc.org

212-639-3099

Study Officials

• Babak Mehara, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: November 8, 2018
• Results First Posted: October 11, 2018

Record last verified: 2018-05

Locations

US (1)