A clinical trial to evaluate the effects of vaccine in patients of Pancreatic cancer
- Conditions
- Health Condition 1: null- Advanced Carcinoma of PancreasHealth Condition 2: C259- Malignant neoplasm of pancreas, unspecified
- Registration Number
- CTRI/2016/05/006953
- Lead Sponsor
- Dr Arun Maseeh Study Director Cadila Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 38
•Histologically or cytologically confirmed malignancy of exocrine pancreas with evidence of locally advanced (non-resectable stage- II or III) ormetastatic disease (stage-IV), with following criteria:
a)Stage-I and stage-II (test-arm-1): Patients who have been refractory to standard chemotherapy (including gemcitabine-based regimens) or any other therapy or for whom no standard therapy exists.
b.Stage-II (test-arm-2): Patients who may have received previous chemotherapy or radiation therapy, but must be amenable for a gemcitabine treatment according to the discretion of investigator.
•Male and female patients with the age of 18 years or above.
•Life expectancy of at least 12 weeks
•Eastern Cooperative Oncology Group (ECOG) performance status: <=2
•Patient with at least one uni-dimensionally measurable lesion by computed
•tomography (CT) scan as defined by Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1)32
•All acute toxic effects (excluding alopecia) of any prior therapy (including surgery,radiation therapy, chemotherapy) must have resolved to National Cancer Institute (NCI) â?? Common Terminology Criteria for Adverse Events (CTCAE, v4.0)29 -Grades <=1.
•Patient with biliary or gastro-duodenal obstruction must have drainage or bypass prior to starting chemotherapy.
•Patient with adequate hepatic function defined as alkaline phosphatase (ALP), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) <=3 x upper limit of reference range (ULN), and total bilirubin <=2.0 x ULN unless liver involvement by the tumor, in which case the transaminase levels could be up to 5 x ULN.
•Patient with adequate renal function defined as serum creatinine (Scr) <=1.5 ULN or calculated 24 hours creatinine clearance (CLCR) >=50 ml/min.
•Patient with adequate hematological function defined as hemoglobin (Hb) >=9.0 mg/dL, absolute neutrophil count (ANC) >=1.5 x 109/L and platelet count >=1 x 1011/L.
•Patient with amylase/lipase <=1.5 times ULN.
•Documented negative test for human immuno virus (HIV-1/2).
•Negative serum pregnancy test for female patient of child-bearing potential within 14 days of starting treatment. Female patient of child bearing potential or sexually active male patient with partners of childbearing potential must use effective birth control measures (e.g., oral contraceptives, condoms, or other adequate barrier controls, intrauterine contraceptive devices, or sterilization) during treatment and at least 6 months after the last dose of the study treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately. If a female partner becomes pregnant during the course of the study, the investigator should be informed immediately.
•Fasting serum cholesterol <=300 mg/dL OR <=7.75 mmol/L and fasting triglycerides <=2.5 x ULN.
Note: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.
•Screening electrocardiogram (ECG) with a time from ECG-Q wave to the end of the T wave corresponding to electrical systole [QT] corrected for heart rate (QTc) <450 msec.
•Subjects who refuse to give written informed consent.
•Patients with known history of allergy or hypersensitivity to investigational drug, gemcitabine or their formulation ingredients, or to other intravenously or intradermally administered human proteins/peptides/antibodies/whole cell lysates.
•Pregnant or lactating female patient.
•Known history or presence of symptomatic metastatic brain or meningeal tumors.
•No active pancreatitis, defined as clinically symptomatic hyperamylasemia and/or hyperlipasemia, and symptomatic cholelithiasis.
•Chemotherapy or radiation therapy within 4 weeks of the administration of study treatment for patients under screening.
•Previous gemcitabine (for test-arm-2 only during stage-II) given concurrently as radiosensitizers to radiotherapy in adjuvant intention if given within 6 months from the start of study treatment.
•Patients with previous or concurrent malignancy except for inactive non-melanoma skin cancer and/or in situ carcinoma of the cervix, or other solid tumor treated curatively and without evidence of recurrence within the last 3 years prior to study entry.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stage I: <br/ ><br>Safety and tolerability of DO-013 to estimate minimal toxicity profile of a dose(28 days post first vaccination) <br/ ><br>Stage II: <br/ ><br>Overall safety and tolerability analysis for DO-013 alone (test-arm-1) in <br/ ><br>comparison to DO-013 plus gemcitabine (test-arm-2) [Time frame: 0-112 <br/ ><br>days] <br/ ><br>Timepoint: Stage I: <br/ ><br>Safety and tolerability of DO-013 to estimate minimal toxicity profile of a dose(28 days post first vaccination) <br/ ><br>Stage II: <br/ ><br>Overall safety and tolerability analysis for DO-013 alone (test-arm-1) in <br/ ><br>comparison to DO-013 plus gemcitabine (test-arm-2) [Time frame: 0-112 <br/ ><br>days] <br/ ><br>
- Secondary Outcome Measures
Name Time Method Stage I: <br/ ><br>Overall safety and tolerability analysis <br/ ><br>Stage II: <br/ ><br>Tumor markers of test-arm-1 versus test-arm-2 <br/ ><br>OS of test-arm-1 versus test-arm-2 <br/ ><br>PFS of test-arm-1 versus test-arm-2 <br/ ><br>Tumor response versus test-arm-2 <br/ ><br>CBR of test-arm-1 versus test-arm-2Timepoint: Stage I: <br/ ><br>Time frame: 0-112 days <br/ ><br>Stage II: <br/ ><br>Tumor markers-Time frame: Baseline, and <br/ ><br>at 57th and 113th day post first vaccination dose <br/ ><br>OS-Time frame: Every 4-week till death <br/ ><br>PFS-Time frame: Every 8-week till disease <br/ ><br>progression or death <br/ ><br>Tumor response-Time frame: Every 8-week till disease progression or <br/ ><br>death <br/ ><br>CBR-0- <br/ ><br>112 days