Recruiting
Phase 1
Phase 2

TNX-650

Sponsor:

Tanox

Code:

NCT00441818

Conditions

Hodgkin's Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TNX-650

Study Details

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.

Conditions

Hodgkin's Lymphoma

Study ID

NCT00441818

Start date

May, 2006

Status verified date

Feb, 2007

Completion date

Jun, 2007

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

59 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

TNX-650

Primary outcome measure

  • To determine the safety and tolerability of TNX-650 for Injection when administered to patients with refractory Hodgkin's Lymphoma (HL) [ Time Frame: undefined ]
  • To determine the maximum tolerated dose (MTD) of TNX-650 for Injection [ Time Frame: undefined ]
  • To determine the systemic exposure to TNX-650 for Injection in patients with refractory HL [ Time Frame: undefined ]
  • 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 [ Time Frame: undefined ]
  • 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 [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Fatai Osinowo, MD

713-578-4332fosinowo@tanox.com

Tad Iwan

713-578-4181tiwan@tanox.com

Locations

MD Anderson Cancer Center - Dept. of Lymphoma and Myeloma

Recruiting

Houston, Texas, United States, 77030-4009

Contacts

Amanda Wedgewood, RN

713-792-9455awedgewood@mdanderson.org

Principal Investigator:

Anas Younes, MD

More Information

Sponsor

Tanox

Last update posted

May 9, 2008

Last verified

Feb, 2007

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Tanox on 2008-05-09.