safety and efficacy study of tnx-650 to treat refractory hodgkin's lymphoma

Conditions: Hodgkin's Lymphoma

Summary: the purpose of this study is to determine the safety and effectiveness of tnx-650 for injection when administered to patients with refractory hodgkin's lymphoma.

hodgkin's lymphoma (hl) is a lymphoid malignancy that accounts for approximately 7,000 to 8,000 new cancer cases per year in the united sates. it occurs with a bimodal age-incidence distribution peaking in the 15- to 30-year old and 50- to 60-year old age groups. the pathological hallmark of the disease is the presence of malignant reed sternberg (rs) cells. reed-sternberg cells are interspersed among a heterogeneous population of non-malignant reactive cells, including t cells, eosinophils, neutrophils, b lymphocytes, plasma cells, histiocytes, fibroblasts, and stromal cells. while more than 80% of patients will respond to initial radiotherapy or combination chemoradiotherapy, some patients will experience early relapse after initial therapy or be refractory to first-line therapy. these patients may be treated with second-line therapy, which may include autologous bone marrow transplantation (bmt). patients with hl who relapse after first- and second-line therapy, or who are refractory to therapy, with or without autologous bmt, have a poor prognosis. the long-term event-free survival rate in this patient group is less than 10%; median survival is 16 months. at present, these patients have no treatment options other than investigational therapies.

Eligibility criteria:
inclusion criteria: * histological diagnosis of relapsed or refractory classical hl * age \>18 years * received and failed potentially curative chemotherapeutic regimens (e.g., abvd, stanford v, or beacopp) * relapsed following autologous bone marrow transplantation (bmt), or are ineligible, or refused bmt * completed radiotherapy, chemotherapy, and/or treatment with other investigational agents at least 3 weeks prior to study entry * completed autologous bmt (if received) at least 3 months prior to study entry; completed allogeneic bmt (if received); at least 6 months prior to study entry * eastern cooperative oncology group (ecog) status of \<2 * life expectancy of \>3 months * laboratory data: * platelet count \>50,000/mm3 * hemoglobin \>9.0 g/dl (may be maintained by transfusion) * absolute neutrophil count \>1000/mm3 * alt/ast \<2.5 times the upper limit of normal (uln) * total bilirubin \<1.5 times uln * creatinine \<1.5 mg/dl * female subjects of childbearing potential must have a negative serum pregnancy test at screening; subjects must agree to use a medically appropriate form of birth control from screening until 6 months after the last dose of study medication * ability to provide written informed consent exclusion criteria: * any significant diseases (other than hl) or clinically significant findings, including psychiatric and behavioral problems, medical history and/or physical examination findings that would preclude the subject from participating in the study * history or clinical evidence of cnetral nervous system (cns) hl * received allogeneic bmt * received growth factor support or transfusions to achieve hematology entry criteria (platelets, hemoglobin, absolute neutrophil count) * major surgery within 4 weeks prior to study entry * known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation * known history of another primary malignancy that has not been in remission for at least 5 years. non-melanoma skin cancer and cervical carcinoma in situ or squamous intraepithelial lesions (e.g., cervical intraepithelial neoplasia \[cin\] or prostatic intraepithelial/intraductal neoplasia \[pin\]) are allowed. * any active viral, bacterial, or systemic fungal infection within 4 weeks prior study entry * known positive for human immunodeficiency virus (hiv), hepatitis b virus surface antigen (hbsag), or hepatitis c virus (hcv) * histry of significant chronic or recurrent infections requiring treatment * receiving systemic steroids exceeding 10 mg prednisone or equivalent, or unstable on steroid medication, during the 3 weeks immediately preceding enrollment * pregnant or breast-feeding