CTRI/2017/11/010583招募中4 期
A Post marketing surveillance study evaluating safety and efficacy of APCEDEN®, an autologous dendritic cell immunotherapy, when administered according to the prescribing information in India (APASS)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1.Patients with a histologically confirmed diagnosis of Prostate, Ovarian, Colo-rectal and Lung cancer.
- •2.As per the physician the cancer should be refractory to at least 2/3 prior therapies, with measurable disease.
- •3.Karnofsky status >= 70% and/or WHO/ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- •4.Life expectancy >= 3 months
- •5.Patient to have adequate venous access(to undergo leukapheresis)
- •6.No known hypersensitivity to APCEDEN® or any of its constituents.
- •7.Three or fewer bone metastases on a bone scan with minimal symptoms.
- •8.No lymph node lesions greater than 3.0 cm at longest diameter.
- •9.Adequate hematological, hepatic and renal function.
- •10.Normal organ function and normal hematological parameters; laboratory parameters should be within normal range, except following laboratory parameters: HEMOGLOBIN >= 10 G/DL; GRANULOCYTES >= 1,500/µL; LYMPHOCYTES >= 1000/µL; PLATELETS >= 100,000/µL; SERUM CREATININ <= 2.0 MG/DL; SERUM BILIRUBIN <= 2.0 MG/DL; AST AND ALT <= 2 X THE NORMAL UPPER LIMITS; LDH <= 1,5X NORMAL UPPER LIMIT; CRP <= 1,5X NORMAL UPPER LIMIT; PROTHROMBIN TIME (PT) INTERNATIONAL NORMALIZED RATIO (INR) AND PARTIAL THROMBOPLASTIN TIME (PTT) WITHIN NORMAL LIMITS
- •11.No prior history of a serious autoimmune disorder
- •12.No concomitant medication with immune suppressive drugs
- •13.No brain metastases leptomeningeal involvement (other than astrocytomas)
- •14.No clinically significant pleural effusion
- •15.No complete tumor obstruction (e.g., bronchus, ureter, or bowel)
- •16.Patient should not be taking concurrent corticosteroids as these may subside the immune function and interfere with immunotherapy response.
- •17.Patient should be able to adhere to the study visit schedule and other protocol requirements
排除标准
- •1.History of other active malignancy.
- •2.Prior chemotherapy, radiation therapy, immunosuppressive or investigational therapy for metastatic disease in previous 12 months.
- •3.Strong opioids, immunosuppressives, megestrol acetate or other estrogenic hormones within 1 month prior to enrollment.
- •4.Brain, liver, or lung metastases; uncontrolled heart, liver, lung, or renal diseases or other serious illness.
- •5.Prior splenectomy.
- •6.History of moderate to severe lower limb lymphedema, or recent signs of deep venous thrombosis (DVT) or thrombo-embolic disease, or impending stroke.
- •7.History of immunodeficiency or autoimmune disease; positive HIV, HbsAg or anti-HCV.
- •8.Impending untreated spinal cord compression or urinary outlet obstruction.
- •9.Any medication that might affect immune function. (Exceptions: Nonprescription doses of NSAIDS; acetaminophen or aspirin; low doses of antihistamine therapy; normal range doses of vitamins; and H2 blockers).
- •10.Pregnant or lactating women.
- •11.Known positive for hepatitis B or C or HIV.
- •12.Underlying cardiac disease associated with myocardial dysfunction that requires active medical treatment, or unstable angina related to atherosclerotic cardiovascular disease, or under treatment for arterial or venous peripheral vascular disease
- •13.Diagnosis of any other invasive cancer which is considered to be life-threatening within the next five years, and/or taking anti-cancer therapy for cancer other than ovarian (such as continuation of hormonal therapy for breast cancer diagnosed more than five years earlier).
- •14.Active infection or other active medical condition that could be eminently life-threatening, including active blood clotting or bleeding diathesis.
- •15.Prior splenectomy.
研究者
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