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

Primary Purpose

Hodgkin's Lymphoma

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TNX-650
Sponsored by
Tanox
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin's Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center
  • MD Anderson Cancer Center - Dept. of Lymphoma and MyelomaRecruiting

Outcomes

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

Full Information

First Posted
May 17, 2006
Last Updated
May 8, 2008
Sponsor
Tanox
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1. Study Identification

Unique Protocol Identification Number
NCT00441818
Brief Title
Safety and Efficacy Study of TNX-650 to Treat Refractory Hodgkin's Lymphoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Unknown status
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Tanox

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin's Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
59 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
TNX-650
Primary Outcome Measure Information:
Title
To determine the safety and tolerability of TNX-650 for Injection when administered to patients with refractory Hodgkin's Lymphoma (HL)
Title
To determine the maximum tolerated dose (MTD) of TNX-650 for Injection
Title
To determine the systemic exposure to TNX-650 for Injection in patients with refractory HL
Title
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
Title
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 Measure Information:
Title
To determine the safety profile of TNX-650 for Injection at the MTD
Title
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
Title
To determine the preliminary efficacy of TNX-650 for Injection at the MTD, based on tumor assessments using CT or MRI, and FDG-PET

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatai Osinowo, MD
Phone
713-578-4332
Email
fosinowo@tanox.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tad Iwan
Phone
713-578-4181
Email
tiwan@tanox.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anas Younes, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Craig Moskowitz, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bri-Anne Wilson
Phone
646-227-2191
Email
wilsonb1@mskcc.org
First Name & Middle Initial & Last Name & Degree
Sarah Alandra Weaver
Phone
646-227-2133
Email
weavers@mskcc.org
First Name & Middle Initial & Last Name & Degree
Craig Moskowitz, MD
Facility Name
MD Anderson Cancer Center - Dept. of Lymphoma and Myeloma
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Wedgewood, RN
Phone
713-792-9455
Email
awedgewood@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Anas Younes, MD

12. IPD Sharing Statement

Links:
URL
http://www.gene.com/gene/index.jsp
Description
Tanox, Inc. website

Learn more about this trial

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

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