A Phase I Study With Lymfactin® in the Treatment of Patients With Secondary Lymphedema

NCT02994771 | Terminated Phase 1 DMC

• 1 other identifier: CL12001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

Brief Summary

Indicated for the Treatment of Secondary Lymphedema Associated with the Treatment of Breast Cancer. Primary objective is to evaluate the safety and tolerability of a single dose of Lymfactin® in patients with secondary lymphedema associated with the treatment of breast cancer.

Conditions

Secondary Lymphedema

Keywords

Lymphedema, Breast cancer

Outcome Measures

Primary Outcomes (4)

• Safety as measured by number of patients with treatment related adverse events and serious adverse events as assessed by CTCAE v4.0

  Adverse events and serious adverse events assessed by CTCAE v4.0 to evaluate the safety profile after administration of Lymfactin

  baseline to 1 year, yearly up to 5 years

• CT scan of chest and abdomen

  Changes in the CT scan of chest and abdomen in order to detect malignancies

  baseline, yearly up to 5 years

• Biodistribution of Lymfactin in blood

  Changes in Lymfactin genome copy number in blood

  90 days

• Formation of anti-Lymfactin antibodies

  Changes in the anti-Lymfactin antibody titer in blood

  6 months

Secondary Outcomes (3)

• Measurement of the volume of the arms

  baseline, 6, 12, 24 and 36 months

• Measurement of the lymphatic flow of the affected arm by quantitative lymphoscintigraphy (99Tc-nanocolloid clearance rate with calculation of transport index)

  baseline, 12, 24 and 36 months

• Questionnaire according to the Lymphedema Quality of Life Inventory (LQOLI)

  baseline, 6, 12, 24 and 36 months

Study Arms (2)

Lymfactin® [1 x 10E10 vp]

ACTIVE COMPARATOR

Lymfactin® \[1 x 10E10 vp\] will be administered as a single dose via perinodal injection in a volume of 2 mL.

Drug: Lymfactin® [1 x 10E10 vp]

Lymfactin® [1 x 10E11 vp]

ACTIVE COMPARATOR

Lymfactin® \[1 x 10E11 vp\] will be administered as a single dose via perinodal injection in a volume of 2 mL.

Drug: Lymfactin® [1 x 10E11 vp]

Interventions

Lymfactin® [1 x 10E10 vp] DRUG

Lymfactin® \[1 x 10E10 vp\] will be administered as a single dose via perinodal injection in a volume of 2 mL.

Also known as: LX-1101, AdAptVEGF-C Adenoviral Vector

Lymfactin® [1 x 10E10 vp]

Lymfactin® [1 x 10E11 vp] DRUG

Lymfactin® \[1 x 10E11 vp\] will be administered as a single dose via perinodal injection in a volume of 2 mL.

Also known as: LX-1101, AdAptVEGF-C Adenoviral Vector

Lymfactin® [1 x 10E11 vp]

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients with secondary lymphedema associated with the treatment of breast cancer.
• Patient who understands and voluntarily signs informed consent prior to any screening procedure.
• years of age.
• BMI between 18 and 32 inclusive.
• Female patients with secondary lymphedema in the arm associated with breast cancer who:
• Have undergone sentinel lymph node biopsies and/or lymph node resection in the axilla on the affected side of their breast cancer with initial N1 staging and lymph node metastasis in ≤ three lymph nodes.
• Require garment use as a compression treatment for the lymphedema in the affected arm.
• Have the volume of the affected arm at least 10% greater than the unaffected arm following 7 days after removal of the compression garments.
• Have the presence of pitting edema in the affected arm without compression garments.
• No evidence of recurrent or active breast cancer at least 2 years and no more than 5 years after breast cancer surgery and/or the end of chemotherapy and/or radiotherapy (excluding endocrine and/or aromatase inhibitor treatment). PET CT scan of the chest and the abdomen within 45 days of treatment with Lymfactin® without signs of active breast cancer or any other malignancy.
• Patient with the following laboratory values:
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the institutional upper limit of normal (ULN)
• Bilirubin ≤ 1.5 mg/dL
• PT and PTT ≤ 1.5 times the ULN
• Serum creatinine ≤ 2 mg/dL

You may not qualify if:

• A patient who had an N2/N3 or a T4 stage breast cancer or an inflammatory breast cancer at the time of the original diagnosis.
• A patient with evidence (clinical, laboratory, or imaging) or history of a neoplasm other than breast cancer (except basal cell carcinoma or cervical in situ carcinoma).
• A patient known to be pregnant, lactating or having a positive or indeterminate pregnancy test.
• Treatment with COX-2 inhibitors should be interrupted from one week prior until 2 weeks post surgery and treatment with Lymfactin®.
• Previous treatment with, or participation in, trial of a gene therapy product.
• Current participation or participation in the preceding two months, in any clinical study apart from a noninterventional study.
• Current treatment with immunosuppressive drugs.
• Current or history of drug, including nicotinecontaining products, or alcohol abuse.
• Known human immunodeficiency virus- or acquired immunodeficiency syndrome-related illness.
• Allergy to any ingredients of the Lymfactin® solution for injection (glycerol, N-2-hydroxyethylpiperazine-N´-2-ethanesulfonic acid (HEPES), sodium hydroxide).
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, that would affect the patient's ability to follow study-related procedures, or that may interfere with the interpretation of study results and, in the Investigator's opinion, would make the patient inappropriate for entry into this study.
• Doubtful availability, in the opinion of the Investigator, to complete the study.

Sponsors & Collaborators

• Herantis Pharma Plc.: lead

Study Sites (3)

Toeoeloe Hospital, Department of Plastic Surgery

Helsinki, Finland

Location

Tampere University Hospital, Department of Plastic Surgery

Tampere, Finland

Location

Turku University Hospital, Department of Plastic Surgery

Turku, Finland

Location

MeSH Terms

Conditions

Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne Saarikko, MD, PhD

  HUCH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2016
• First Posted: December 16, 2016
• Study Start: June 1, 2016
• Primary Completion: February 3, 2019
• Study Completion: April 5, 2022
• Last Updated: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (3)