Breast Cancer Stage IIIAPhase 3NCT03202446
Randomized Clinical Trial Evaluating the Use of the Laser-Assisted Immunotherapy (LIT/inCVAX) in Advanced Breast Cancer
A Phase 3 study testing 1% Glycated Chitosan, Photothermal Laser and Cyclophosphamide in people with Breast Cancer Stage IIIA and Breast Cancer, Stage IIIB, run by Eske Corporation S.A.C at 4 sites in Peru.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Stage IIIA, Breast Cancer, Stage IIIB, Breast Cancer Stage IV
- What is being tested?
- 1% Glycated Chitosan, Photothermal Laser and Cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 4 sitesPeru
- Study dates
- 13 Jun 2016to Jan 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- Patient has life expectancy ≥ 6 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 with previous treatment failed (no more lines available for patient treatments including chemotherapy, radiation therapy , monoclonal antibodies), described by NCI guidelines and described in the patient's medical report.
- 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 and patients who are not of child-bearing potential (males and females, e.g.post menopause). Women of child-bearing potential must have a negative serum pregnancy test just prior to first treatment. The study will provide a barrier method (e.g. condoms, etc).
- Patient fits into the pre-defined stratification schedule
Who cannot join
- 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.
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- 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.
- 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, abnormal hyper-coagulation profile, 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 breastfeeding.
Trial locations and contacts
4 sites in 1 country.
Peru4 sites
Clinica Ricardo Palma
Lima
Hospital Maria Auxiliadora
Lima
Hospital Nacional Arzobispo Loayza
Lima
Hospital Nacional Guillermo Almenara Irigoyen
Lima
About this study
Official title: Phase 3 Randomized Clinical Trial Evaluating the Use of the Laser-Assisted Immunotherapy (LIT) System in Advanced Breast Cancer
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.
Read the detailed description
Laser-Assisted Immunotherapy (LIT) is intended to a systemic anti-tumor immune response by priming a tumor with laser energy to liberate an array of tumor antigens from whole cells, immediately followed by administration of the immune stimulant Glycated Chitosan (GC), which is designed to activate antigen presenting cells and facilitate the uptake of tumor antigens. In turn, the antigen presenting cells activate the patient's immune system, resulting in an immune response towards the remaining tumor(s).
In this study it is investigated if the addition of low-dose cyclophosphamide increases the anti-tumor immune response of LIT, as well as comparing the effect of LIT plus Placebo or LIT plus low-dose cyclophosphamide to a control arm of patients receiving Standard of Care therapy.
- Being tested
- 1% Glycated Chitosan, Photothermal Laser, Placebo, Cyclophosphamide, Standard of Care
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% Glycated ChitosanDrug
Also called GC
Photothermal LaserDevice
PlaceboDrug
CyclophosphamideDrug
Standard of CareDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: 1% Glycated Chitosan; Device: Photothermal Laser; Drug: Cyclophosphamide |
| Arm 3: Control Arm | Active comparator | Patients will receive the standard of care. Receives: Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed as week 52
Secondary outcomes (3)
Overall Survival
Overall survival (OS): There will be an OS comparison between the treatment arms 1 and 2 vs. control arm at the end of the 52 week trial.
Measured: Week 0 through Week 52 of study period
Relative change in overall tumor burden
Patients demonstrate a 20% improved relative overall change of total tumor burden compared to the control group at the end of the 52 week trial period.
Measured: Week 0 through Week 52 of study period
Health Related Quality of Life (HRQOL)
To assess and compare the HRQOL of those that receive laser-assisted immunotherapy vs Control. HRQOL refere to a multidimensional assessment that includes at least the physical, emotional (or psychological) and social domain, and may also include cognitive functioning, sexuality, and spirituality. The Assessment will be QOL Scale/Breast Cancer designed by NATIONAL MEDICAL CENTER AND BECKMAN RESEARCH INSTITUTE.
Measured: Week 0 through Week 52 of study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start13 Jun 2016
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Stage IIIAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eske Corporation S.A.C
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Enrique Freitas, MD, Principal investigator, Ricardo Palma Clinica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202446
- Sponsor's protocol ID
- IP-LIT-P003
- Status last verified
- Feb 2018
- First submitted
- 16 Jun 2017
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Randomized Clinical Trial Evaluating the Use of the Laser-Assisted Immunotherapy (LIT) System in Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT03202446
- Acronym / sponsor ID
- IP-LIT-P003
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Eske Corporation S.A.CIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Laser-Assisted Immunotherapy (LIT) is intended to a systemic anti-tumor immune response by priming a tumor with laser energy to liberate an array of tumor antigens from whole cells, immediately followed by administration of the immune stimulant Glycated Chitosan (GC), which is designed to activate antigen presenting cells and facilitate the uptake of tumor antigens. In turn, the antigen presenting cells activate the patient's immune system, resulting in an immune response towards the remaining tumor(s).
In this study it is investigated if the addition of low-dose cyclophosphamide increases the anti-tumor immune response of LIT, as well as comparing the effect of LIT plus Placebo or LIT plus low-dose cyclophosphamide to a control arm of patients receiving Standard of Care therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: LIT and Placebo | Experimental | Drug: 1% Glycated Chitosan, Device: Photothermal Laser, Drug: PlaceboPatients 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. |
| Arm 2: LIT and low-dose Cyclophosphamide | Experimental | Drug: 1% Glycated Chitosan, Device: Photothermal Laser, Drug: CyclophosphamidePatients 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. |
| Arm 3: Control Arm | Active comparator | Drug: Standard of CarePatients will receive the standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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:
- Patient is willing to provide written informed consent and agrees to comply with visit schedule.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1% Glycated ChitosanAlso: GC | Drug | 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 |
Primary outcome
Overall Response Rate
Time frame: Assessed as week 52
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.
3 secondary outcomes
Overall Survival
Time frame: Week 0 through Week 52 of study period
Relative change in overall tumor burden
Time frame: Week 0 through Week 52 of study period
Health Related Quality of Life (HRQOL)
Time frame: Week 0 through Week 52 of study period
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrique Freitas, MD principal investigator
Ricardo Palma Clinica
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 1% Glycated Chitosan, Photothermal Laser and Cyclophosphamide in people with Breast Cancer Stage IIIA and Breast Cancer, Stage IIIB, run by Eske Corporation S.A.C at 4 sites in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: Assessed as week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018.