A Pilot Study of Radioimmunotherapy with Iodine-131 Basiliximab Anti-CD25 Antibody for Relapsed or Refractory Hodgkins Disease and Other Lymphoproliferative Malignancies Expressing IL-2R

South Metropolitan Area Health Service WA0 个研究点目标入组 10 人开始时间: 2005年12月23日最近更新: 2020年1月13日

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•Refractory histologically proven lymphoma i.e. patients who have been treated with at least a first or second line conventional chemotherapy which may include ABMT/PBSCT and have subsequently relapsed.Lymphoproliferative malignancies immunohistocytochemically shown to express IL-2R (CD25)Measurable disease either clinically or radiologically by X-ray, CT, US or MRI or FDG PET scan. Age =18 years.Life expectancy = 3 months.ECOG performance status < 2No anti-lymphoma treatment in the previous 6 weeks (if on steroids a stable dosage over the same period is required).Haematological and biochemical indices:i) Absolute neutrophil count of =1.5 x 10^9 /litre.ii) Haemoglobin = 10g/dl.iii) Platelet count = 100 x 10^9/litre.iv) Plasma creatinine =150 µmol/l or GFR = 50ml/min.v) Plasma bilirubin = 30 µmol/l. vi) ALT/AST =2x upper limit of normal (5x upper limit of normal in the presence of liver metastases).vii) Thyroid function either normal or if the patient has a known thyroid abnormality, it must be stable on treatment.Signed written informed consent.

•Poor renal function (creatinine level > 150µmol/l), poor hepatic function (total bilirubin level > 30mmol/l, transaminases > 2.5 maximum normal level) unless these abnormalities are related to the lymphoma. Poor bone marrow reserve as defined by neutrophils < 1.5 x 10^9/L or platelets <100 x 10^9/L. Cardiac failure (NYHA class III-IV)Patients who are poor medical risks because of non-malignant systemic disease, as well as those with active uncontrolled infection.Documented infection with HIV, HBC, HHV8 and HBV (in the absence of vaccination)Central nervous system or meningeal involvement by lymphomaAny serious active disease or co-morbid condition (according to the investigator’s decision and information provided in the IDB).Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage O (in situ) cervical carcinomaTreatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the studyPregnant or lactating women, or women of child bearing potential in whom pregnancy cannot be excluded. Patients of child bearing/child fathering potential not using adequate medically approved contraception 4 weeks before, during the study and for six months afterwards.Adult patient unable to provide informed consent because of intellectual impairment.

发起方

South Metropolitan Area Health Service WA