Safety and Efficacy Study of TNX-650 to Treat Refractory Hodgkin's Lymphoma
A Phase I/II, Non-Randomized,Multiple-Dose,Dose Escalation Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of TNX-650 in Patients With Refractory Hodgkin's Lymphoma
1 other identifier
interventional
59
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2006
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 17, 2006
CompletedFirst Posted
Study publicly available on registry
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedMay 9, 2008
February 1, 2007
May 17, 2006
May 8, 2008
Conditions
Outcome Measures
Primary Outcomes (5)
To determine the safety and tolerability of TNX-650 for Injection when administered to patients with refractory Hodgkin's Lymphoma (HL)
To determine the maximum tolerated dose (MTD) of TNX-650 for Injection
To determine the systemic exposure to TNX-650 for Injection in patients with refractory HL
To determine phosphorylated STAT-6 and IL-13Rα1 levels in tumor samples, and serum IL 13 levels, which may be useful as early prognostic indicators of efficacy in later clinical studies
To determine the preliminary efficacy of TNX-650 for Injection at the maximum tolerated dose (MTD) or pharmacologically active dose, if MTD is not reached, based on tumor assessments using computed tomography (CT) or magnetic resonance imaging (MRI), and
Secondary Outcomes (3)
To determine the safety profile of TNX-650 for Injection at the MTD
To determine phosphorylated STAT-6 and IL-13Rα1 levels in tumor samples, and serum IL 13 levels, which may be useful as early prognostic indicators of efficacy in later clinical studies
To determine the preliminary efficacy of TNX-650 for Injection at the MTD, based on tumor assessments using CT or MRI, and FDG-PET
Interventions
Eligibility Criteria
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
- +2 more criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanoxlead
Study Sites (2)
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
MD Anderson Cancer Center - Dept. of Lymphoma and Myeloma
Houston, Texas, 77030-4009, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anas Younes, MD
M.D. Anderson Cancer Center
- PRINCIPAL INVESTIGATOR
Craig Moskowitz, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 17, 2006
First Posted
March 1, 2007
Study Start
May 1, 2006
Study Completion
June 1, 2007
Last Updated
May 9, 2008
Record last verified: 2007-02