Randomized Clinical Trial Evaluating the Use of the Laser-Assisted Immunotherapy (LIT/inCVAX) in Advanced Breast Cancer

NCT03202446 | Terminated Phase 3 DMC

• 1 other identifier: IP-LIT-P003
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

Brief Summary

Our study evaluates the use of Laser-Assisted Immunotherapy (LIT) plus placebo and LIT plus low-dose cyclophosphamide versus that of Standard of Care in patients presenting with Stage IIIA, IIIB or IV breast cancer. One-third of enrolled patients will receive LIT plus placebo, one-third will receive LIT plus low-dose cyclophosphamide, and one-third will be assigned to a control group that receives Standard of Care.

Conditions

Breast Cancer Stage IIIA; Breast Cancer, Stage IIIB; Breast Cancer Stage IV

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Overall response rate (ORR) (defined as the percent of patients within each treatment group that achieved complete or partial response, according to irRC, at the end of week 52) comparison between each LIT group and control group.

  Assessed as week 52

Secondary Outcomes (3)

• Overall Survival

  Week 0 through Week 52 of study period

• Relative change in overall tumor burden

  Week 0 through Week 52 of study period

• Health Related Quality of Life (HRQOL)

  Week 0 through Week 52 of study period

Study Arms (3)

Arm 1: LIT and Placebo

EXPERIMENTAL

Patients receive laser-assisted immunotherapy along with Placebo cyclophosphamide tablets. Patients' laser-assisted immunotherapy treatment will be based on the number and size of laser-accessible solid tumors available at the time of treatment. In and around each photothermal laser-treated site will be injected 1 mL of 1% Glycated Chitosan (GC) Injection, with a total of up to 4 sites being treated per patient. The maximum dose of GC Injection that a patient can receive in 1 visit is 4 mL.

Drug: 1% Glycated Chitosan; Device: Photothermal Laser; Drug: Placebo

Arm 2: LIT and low-dose Cyclophosphamide

EXPERIMENTAL

Patients will receive laser-assisted immunotherapy and low-dose cyclophosphamide (300 mg, administered orally once per week between treatment weeks 0-11 in each treatment cycle). Patients' laser-assisted immunotherapy treatment will be based on the number and size of laser-accessible solid tumors available at the time of treatment. In and around each photothermal laser-treated site will be injected 1 mL of 1% Glycated Chitosan (GC) Injection, with a total of up to 4 sites being treated per patient. The maximum dose of GC Injection that a patient can receive in 1 visit is 4 mL.

Drug: 1% Glycated Chitosan; Device: Photothermal Laser; Drug: Cyclophosphamide

Arm 3: Control Arm

ACTIVE COMPARATOR

Patients will receive the standard of care.

Drug: Standard of Care

Interventions

1% Glycated Chitosan DRUG

Also known as: GC

Arm 1: LIT and Placebo; Arm 2: LIT and low-dose Cyclophosphamide

Photothermal Laser DEVICE

Arm 1: LIT and Placebo; Arm 2: LIT and low-dose Cyclophosphamide

Placebo DRUG

Arm 1: LIT and Placebo

Cyclophosphamide DRUG

Arm 2: LIT and low-dose Cyclophosphamide

Standard of Care DRUG

Arm 3: Control Arm

Eligibility Criteria

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

You may qualify if:

• Patient is ≥18 years of age
• Patient must have measurable disease that has progressed despite their current and past treatment plans and with not more treatments lines available according NCI guidelines, described in the subject medical report.
• 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:
• Bone Marrow Function:
• Absolute neutrophil count (ANC) ≥1.5 × 103/mm3
• Platelets \>75 × 103/mm3
• Hemoglobin ≥9 g/dL
• Hepatic Function:
• AST and ALT ≤3 × upper limit of normal (ULN); if liver metastases, then ≤5 × ULN.
• Bilirubin ≤2.0 × ULN.
• Renal 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 is willing to participate in yearly follow-up calls for an additional 4 years after the completion of the 12 month study period.

You may not qualify if:

• 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). Patient should be free of corticosteroid use for at least 18 weeks prior to trial enrollment
• Patient has received treatment with chemotherapy, radiation, hormones, antibody or other immunotherapy, gene therapy, vaccine therapy, or an investigational product like a 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.

Sponsors & Collaborators

• Eske Corporation S.A.C: lead

Study Sites (4)

Clinica Ricardo Palma

Lima, Peru

Location

Hospital Maria Auxiliadora

Lima, Peru

Location

Hospital Nacional Arzobispo Loayza

Lima, Peru

Location

Hospital Nacional Guillermo Almenara Irigoyen

Lima, Peru

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

glycated chitosan; Cyclophosphamide; Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Enrique Freitas, MD

  Ricardo Palma Clinica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: June 28, 2017
• Study Start: June 13, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: February 23, 2018

Record last verified: 2018-02

Locations

PE (4)