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

Sponsored by:	Tanox
Information provided by:	Tanox
ClinicalTrials.gov Identifier:	NCT00441818

Purpose

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.

Condition	Intervention	Phase
Hodgkin's Lymphoma	Drug: TNX-650	Phase I Phase II

MedlinePlus related topics: Cancer Hodgkin's Disease Lymphoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Tanox:

Primary Outcome Measures:

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 Outcome Measures:

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

Estimated Enrollment:	59
Study Start Date:	May 2006
Estimated Study Completion Date:	June 2007

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 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441818

Contacts

Contact: Fatai Osinowo, MD	713-578-4332	fosinowo@tanox.com
Contact: Tad Iwan	713-578-4181	tiwan@tanox.com

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center	Not yet recruiting
New York, New York, United States, 10021
Contact: Bri-Anne Wilson 646-227-2191 wilsonb1@mskcc.org
Contact: Sarah Alandra Weaver 646-227-2133 weavers@mskcc.org
Principal Investigator: Craig Moskowitz, MD
United States, Texas
MD Anderson Cancer Center - Dept. of Lymphoma and Myeloma	Recruiting
Houston, Texas, United States, 77030-4009
Contact: Amanda Wedgewood, RN 713-792-9455 awedgewood@mdanderson.org
Principal Investigator: Anas Younes, MD

Sponsors and Collaborators

Tanox

Investigators

Principal Investigator:	Anas Younes, MD	M.D. Anderson Cancer Center
Principal Investigator:	Craig Moskowitz, MD	Memorial Sloan-Kettering Cancer Center

More Information

Tanox, Inc. website This link exits the ClinicalTrials.gov site

Study ID Numbers:	TNX-650.101
Study First Received:	May 17, 2006
Last Updated:	May 8, 2008
ClinicalTrials.gov Identifier:	NCT00441818
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Lymphatic Diseases
Hodgkin's disease
Immunoproliferative Disorders
Hodgkin lymphoma, adult

Lymphoproliferative Disorders
Hodgkin Disease
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 14, 2009