Status:
UNKNOWN
Safety and Efficacy Study of TNX-650 to Treat Refractory Hodgkin's Lymphoma
Lead Sponsor:
Tanox
Conditions:
Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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.
Detailed Description
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 peaki...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2007
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00441818
Start Date
May 1 2006
End Date
June 1 2007
Last Update
May 9 2008
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
2
MD Anderson Cancer Center - Dept. of Lymphoma and Myeloma
Houston, Texas, United States, 77030-4009