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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02494206
• Other study ID #: 15-085
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: May 2018

Study information

• Verified date: May 2018
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymphedema
• Upper Extremity Lymphedema

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center