Health Condition 1: C53- Malignant neoplasm of cervix uteri
Conditions
Interventions
Intervention1: Intervention (Arm-1)
Conventional concurrent chemo-radiotherapy with placebo (saline
given intradermally)
: Vaccine will be administrated on day 0, 14, 28, 42, 72, 102, 132, 162, 192 &
Sponsors
Department of Science and Technology DST
Eligibility
Inclusion criteria
Inclusion criteria: 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 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of Immune response using in vitro and in vivo assaysTimepoint: Visit 3 (Day 12) Visit 9 (Day 102), Visit 12 (Day 192), visit 14 (Day 152) | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Assessment of clinical response b) Disease Free Survival (DFS) c) Overall Survival (OS) d) Toxicity of the treatment Timepoint: Once in three months followed by last dose of vaccine | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
Cancer Institute
Outcome results
None listed