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

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Hodgkin's Lymphoma

In brief

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.

Key facts

Study ID

NCT00441818

Run by

Tanox

People needed

59

Starts

2006-05-01

Expected to finish

2007-06-01

Last updated by the study team

2008-05-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• MD Anderson Cancer Center - Dept. of Lymphoma and Myeloma — Houston, Texas, United States (enrolling)
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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