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

Inclusion Criteria

• •1. Female patients with secondary lymphedema associated with the treatment of breast cancer.
• •2. Patient who understands and voluntarily signs informed consent prior to any screening procedure.
• •3. 18 - 70 years of age.
• •4. BMI between 18 and 32 inclusive.
• •5. Female patients with secondary lymphedema in the arm associated with breast cancer who:
• •1. 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.
• •2. Require garment use as a compression treatment for the lymphedema in the affected arm.
• •3. Have the volume of the affected arm at least 10% greater than the unaffected arm following 7 days after removal of the compression garments.
• •4. Have the presence of pitting edema in the affected arm without compression garments.
• •6. 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.
• •7. Patient with the following laboratory values:
• •1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the institutional upper limit of normal (ULN)
• •2. Bilirubin ≤ 1.5 mg/dL
• •3. PT and PTT ≤ 1.5 times the ULN
• •4. Serum creatinine ≤ 2 mg/dL
• •5. Absolute neutrophil count (ANC) ≥ 1,500 cells/mm³
• •6. Platelet count ≥ 100,000/mm³
• •7. Hemoglobin ≥ 10 g/dL
• •8. Willingness to comply with scheduled visits, laboratory assessments, and other study-related procedures due to the regulatory requirements related to gene based therapies.
• •9. Non-smoker or willing to stop smoking or using nicotine-containing products for at least 4 weeks prior to entry to study.
• •10. Negative urine pregnancy test (only patients with childbearing potential) at screening and use of adequate contraceptive measures from screening until 6 months after the study treatment administration:
• •1. A patient with childbearing potential should be using a reliable contraception method: intrauterine device (hormonal or non-hormonal); oral combination pill or hormonal contraception patch; or two of the following: intra-vaginal hormonal ring, oral contraceptive containing progestin only, spermicidal foam, condom, sterilization of male sexual partner (surgical vasectomy).
• •2. A patient with no current heterosexual relationship may be included according to the judgement of the Investigator.
• •3. If the patient is surgically sterile or whose menopause occurred 2 years previously at the minimum, no contraception is required nor pregnancy test.