Safety and Efficacy Study of TNX-650 to Treat Refractory Hodgkin's Lymphoma

• Status: Unknown status
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tanox

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