Cancer immunotherapy - dendritic cell vaccine based immunotherapy in cervicalcancer - A phase II, double blind, randomized, three arm study to evaluate theefficacy of dendritic cell vaccine in stage IIIB cervical cancer

Department of Science and Technology DST0 个研究点目标入组 54 人开始时间: 待定最近更新: 2024年3月4日

试验速览

暂无简介。

•1 Subjects in the age group of 18-65 years
•2 Histologically confirmed diagnosis of malignancy (Squamous cell carcinoma)
•3 HPV positivity determined by PCR.
•4 SPAG9 positivity determined by Immunohistochemistry.
•5 Stage IIIB cervical cancer
•6 No prior Radiotherapy or chemotherapy for any other malignancy;
•7 Karnofsky score of 70 or greater;
•8 No allergy to components of the DCs
•9 Normal baseline hematological parameters (within 1 week before first vaccination): hemoglobin > 9.5 g/dl; total granulocyte count > 1000 per microliter; platelet count > 60,000 per microliter; BUN < 30 mg per dl; creatinine <2 mg per dl; alkaline phospatase; aspartate aminotransferase less than twice the upper limit of normal; and a prothrombin time no greater than 1.4 times control, unless therapeutically warranted.
•10 No contraindications for chemotherapy with cisplatin
•11 Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study
•12 Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedure

•1 HIV or Hepatitis B or C infection
•2 Patients with history of auto-immune disease
•3 Pregnancy
•4 Severe pulmonary or cardiac disease
•5 Uncontrolled diabetes or hypertension
•6 Presence of acute infection requiring treatment
•7 Patients on immunosuppressive drugs including steroids
•8 Significant obstructive uropathy.
•9 Unwillingness to use a medically accepted form of birth control during the study.
•10 Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
•11 Patients who have participated in any other clinical trial during the past 90 days.

发起方

Department of Science and Technology DST