PHASE 3 RANDOMIZED CLINICAL TRIAL EVALUATING THE USE OF THE LASER-ASSISTED IMMUNOTHERAPY (LIT) SYSTEM IN ADVANCED BREAST CANCER

Not Applicable

Recruiting

• Conditions: -C509 Breast, unspecified; Breast, unspecified; C509

• Registration Number: PER-020-15
• Lead Sponsor: ESKE CORPORATION SAC,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-11
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 0

Inclusion Criteria

•Patient is ≥18 years of age.
•Patient must have measurable disease.
•Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0–1.
•Patient has adequate organ function, confirmed by the following laboratory values obtained ≤14 days prior to the first treatment:
oBone Marrow Function:
Absolute neutrophil count (ANC) ≥1.5 × 109/L.
Platelets >75 × 109/L.
Hemoglobin ≥9 × 109/L.
oHepatic Function:
AST and ALT ≤3 × upper limit of normal (ULN); if liver metastases, then ≤5 × ULN.
Bilirubin ≤2.0 × ULN.
oRenal Function:
Serum creatinine ≤2.0 × ULN or a creatinine clearance of >60 mL/min the calculation of the creatinine clearance will be performed using the cockcroft gault equation (CRCL).
•Patient is willing to provide written informed consent and agrees to comply with visit schedule.
•Patient has life expectancy ≥3 months.
•Patient has Stage 3b, 3c or stage 4 breast cancer and has a laser-accessible solid tumor that is palpable to touch allowing insertion of interstitial laser fiber without imaging techniques. At least one palpable tumor must be >1 cm.
•Patient with relapsed or refractory laser-accessible breast cancer, and where the investigator believes that the patient will not require surgical intervention for at least 12 weeks.
•Patients who are of child-bearing potential (males and females) using an effective method of contraception during the treatment period and for at least 6 months after the last dose of treatment. Women of child-bearing potential must have a negative pregnancy test up to 28 days prior to first treatment and a negative pregnancy test confirmed prior to first treatment.
•Patient fits into the pre-defined stratification schedule (see above for stratification schedule)

Exclusion Criteria

•Patient has received prior treatment with glycated chitosan or laser-assisted immunotherapy GC Injection.
•Patient has a known allergic reaction to shellfish, crabs, crustaceans, or any study components used in treatment.
•Patient has symptomatic or untreated CNS disease, including seizures. Patients with asymptomatic CNS metastases are eligible provided that they have been clinically stable for a minimum of 4 weeks and are not on steroid treatment.
•Patient has impaired cardiac function of clinical significance or has experienced within 6 months of initiation of treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
•Patient has an implantable pacemaker or cardioverted defibrillator within 5 cm of the laser-accessible solid tumor to be treated with laser-assisted immunotherapy.
•Patient has uncontrolled hypertension.
•Patient has an ongoing requirement for therapeutic anticoagulation therapy (low-dose anticoagulants or low molecular weight heparin for the prevention of deep vein thrombosis and maintenance of patency of central venous devices is allowed)
•Patient has HIV or AIDS or history of chronic hepatitis B or C (those who are considered cured of chronic hepatitis B or C may be allowed). Physician may test the patient for hepatitis and exclude the patient if the test is positive. Patient has a serious autoimmune disease (e.g., Lupus). Consultation with medical monitor is required to discuss enrollment if patient has autoimmune disease.
•Patient has an active infection requiring antibiotics.
•Patient has presence of ascites or pleural effusion requiring chronic medical intervention.
•Patient is receiving concomitant treatment with systemic corticosteroids (e.g., predisone) or other immunosuppressive therapy (e.g., methotrexate). Topical (but not at the proposed treatment site) or inhalation steroids are permitted.
•Patient has received treatment with chemotherapy, radiation, hormones, antibody or other immunotherapy, gene therapy, vaccine therapy, or any other investigational treatment for cancer within 4 weeks prior to the start of the study treatment or within 5 t1/2 of a drug, whichever is shorter.
•Patient has unresolved toxicities from prior anticancer therapy that may limit the ability to remain in the study.
•Patient has had a surgical procedure ≤14 days prior to the first scheduled treatment; in all cases, the patient must be sufficiently recovered and stable before treatment administration.
•Patient has any serious or unstable concomitant systemic conditions that are incompatible with this clinical study (e.g., substance addiction, psychiatric disturbance, or uncontrolled intercurrent illness including active infection, arterial thrombosis, or symptomatic pulmonary embolism) or would complicate the study.
•Patient has any other condition that may cause an increased risk associated with the study participation or may interfere with the interpretation of study results, and in the opinion of the investigator, would make the patient inappropriate for entry into this study.
•Patient is pregnant, lactating, or breast feeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified