Trial to Optimally Show the Pharmacological Action of Z-100

Study Overview
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Brief Summary
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The objective of this clinical trial is to evaluate the change of the immunological parameter levels in FIGO stage IIIB cervical cancer subjects by administration of Z-100

Official Title
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Z-100 Pharmacological Trial: A Randomised Placebo-controlled Trial of Z-100 Plus Radiation Therapy in Subjects With Locally Advanced Cervical Cancer

Conditions
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Cervical Cancer

Intervention / Treatment
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* Drug: Z-100
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: FIGO stage (2008): IIIB, cervical cancer Pathologically confirmed squamous cell carcinoma of the cervix Subjects with treatment-naive cervical cancer Subjects without enlargement (≥15 mm in the short axis) in the lower abdominal para-aortic lymph node Subjects ≥21, ≤79 years of age at informed consent Subjects for whom it is considered possible to carry out intracavitary radiation in radiotherapy Subjects for whom it is considered possible to carry out concurrent cisplatin treatment with radiotherapy Eastern Cooperative Oncology Group Performance Status: 0-2 Subjects with the following organ functions; (1) WBC ≥3,000/mm3 (2) Platelet count ≥100,000/mm3 (3) Hemoglobin ≥9.5 g/dL (correction by medication, e.g. blood transfusion, iron compounds, is allowed) (4) Total bilirubin ≤ three (3) times the upper limit of reference value at the clinical testing laboratory (5) AST, ALT ≤ three (3) times the upper limit of reference value at the clinical testing laboratory (6) Creatinine clearance: ≥50 mL/min Subjects who are willing to give informed consent Exclusion Criteria: Subjects who have a double cancer or are being treated for that Subjects who have suffered from cancers other than cervical cancer within 5 years prior to obtaining consent Subjects with cancer of the cervical stump which is judged by the investigator Subjects who have a history of being diagnosed of autoimmune disease Subjects who have a history of radiotherapy in the pelvis Subjects who have a history of hypersensitivity to cisplatin or other medical agents which contain platinum Subjects complicated with a serious drug allergy Subjects with a serious complication (poorly controlled hypertension, haemorrhagic tendency, connective tissue disease being treated with steroid) Pregnant women, nursing mothers or subjects who desire pregnancy during the trial period Subjects who have ongoing infection of human immunodeficiency virus (HIV), active hepatitis B virus (HBV), hepatitis C virus (HCV) Subjects with symptomatic tuberculosis at the date of obtaining consent Subjects who have received any other investigational medicinal products or medical devices within 28 days prior to obtaining consent Other subjects considered inappropriate to participate in the trial by the investigator

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebos<br>* Twice a week until 29 days after completion of chemoradiotherapy, then once every 14 days<br>|
| Experimental: 0.2 microgram Z-100<br> | Drug: Z-100<br>* Twice a week until 29 days after completion of chemoradiotherapy, then once every 14 days<br>|
| Experimental: 2 microgram Z-100<br> | Drug: Z-100<br>* Twice a week until 29 days after completion of chemoradiotherapy, then once every 14 days<br>|
| Experimental: 20 microgram Z-100<br> | Drug: Z-100<br>* Twice a week until 29 days after completion of chemoradiotherapy, then once every 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the number of immunological cells |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 3 years | 
| Disease-specific survival |  | 2 years | 
| Recurrence-free survival |  | 3 years | 
| Rate of adverse events/adverse drug reactions |  | 2 years |