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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Tanox.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tanox
ClinicalTrials.gov Identifier:
NCT00441818
First received: May 17, 2006
Last updated: May 8, 2008
Last verified: February 2007
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

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

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 29, 2014