Safety and tolerability evaluation study of BVAC-C in patients with HPV type 16 or 18 positive cervical cancer after failure to standard care
- Conditions
- Neoplasms
- Registration Number
- KCT0002115
- Lead Sponsor
- Cellid
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 9
? Patients with multiple metastatic progressive or recurrent HPV type 16 or 18 positive cervical cancer
? Patients has received 1 or more platinum based doublet chemotherapy as prior therapy for progressive or recurrent tumor lesion (prior therapy does not include platinum chemotherapy given with radiation therapy for 1st line treatment before progression or recurrence)
? Patients with at least 1 measurable lesion according to RECIST(Response Evaluation Criteria In Solid Tumors)
? Female patients between ages of 20 to 70
? Patients with ECOG(Eastern Cooperative Oncology Group) perfomance status between 0 to 2
? Patients meets the blood test standards in the screening test
ANC(absolute neutrophil count)=1500/µL
LLN(lower limit of normal) =ALC(absolute neutrophil count) =ULN(upper limit of normal)
Platelets=100,000/µL
Hemoglobin> 9g/dL
? Patients meets the blood chemistry test standards in the screening test
Serum creatinine = 2.0 mg/dL
Calculated creatinine clearance = 50 mL/min
Serumbilirubin =1.5 x ULN(upper limit of normal)
ALT(alanine transaminase) and AST(aspartate transaminase ) =2.5 × ULN(upper limit of normal) (= 5 x ULN(upper limit of normal) in patients with liver metastases)
? Patients who has agreed to a medically accepted contraceptive in this clinical trial
? Patients at least three months or more of survival can be expected
? Patients decided to participate in this clinical trial and signed written informed consent
? Patients histopathology is a neuroendocrine or small cell carcinoma
? Patients with a history of brain metastasis or signs of brain metastasis
? Patients tested positive in serological tests for hepatitis C virus or hepatitis B virus surface antigen , (HBsAg) or human immunodeficiency virus (HIV)
? Patients with a history of HIV infection
? Patients showing abnormal electrocardiogram , including arrhythmia
? Patients have been administered the drug for other clinical trials within 4weeks before the screening visit
? Patients have been administered any vaccines within 4weeks before the screening visit (eg. hepatitis A, hepatitis B, influenza , Td , etc. )
? Patients have been administered the blood products within 3 months before the screening visit
? Patients have received chemotherapy or radiation therapy within 4weeks before the 1st administraion of investigational drug(BVAC-C)
? Patients treated with immunosuppressant or immunomodulatory agents within 6 months before the screening visit
? Patients who have participated in the clinical trial of a therapeutic vaccine or immune therapy within 1 year before the screening visit
? Patients with a history of serious allergic disease or serious side effects of the drug
? Patients who is pregnant or breast-feeding
? Patients researchers has determined that participation in the clinical trial is inappropriate
? Patients suspected to have other primary cancer differ from cervical cancer
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method DLT(Dose Limit Toxicity);Analyze adverse drug reaction by CTCAE
- Secondary Outcome Measures
Name Time Method Clinical laboratory tests ;12-lead ECG ;Vital signs ;Physical examination