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Study Summary
No. 2006-0011:.......Lymphoma......Anas Younes......Lymphoma/Myeloma
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Study Summary Title
Study Summary
Number:
2006-0011
Study 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
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Physician New Patient Referral
Name:Anas YounesPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Lymphoma/MyelomaReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2860
Contact us about clinical trials
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General Information
Disease Group:LymphomaSupported By:N/A
Phase of Study:Phase I/Phase IIReturn
Visit:
Week 1 thru week 9 weekly
Week 11 thru week 13 every other week
Week 15 thru week 17 weekly
Week 19 thru week 24 every other week
Treatment
Agents:
TNX-650Home Care:N/A
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of this clinical research study is to determine the safety and
effectiveness of TNX-650 given to patients with Hodgkin's Lymphoma.
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Study Objectives / Outcomes
Part A:
  • 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 measure phosphorylated STAT-6 and IL-13Rá1 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 fluorodeoxyglucose
    positron emission tomography (FDG-PET)

Part B:
  • To determine the safety profile of TNX-650 for Injection at the MTD.
  • To measure phosphorylated STAT-6 and IL-13Rá1 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.
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Study Status Information
Study Activation / Registration Date:05/03/2006
IRB Review and Approval Date:03/01/2006
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Closed
Projected Accrual:Up to 71
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Histological diagnosis of relapsed or refractory classical HL.

2) Age >/= 18 years.

3) Received and failed potentially curative chemotherapeutic regimens (e.g., ABVD, Stanford V, or BEACOPP).

4) Relapsed following autologous or allogeneic BMT, or are ineligible, or refused BMT.

5) Completed radiotherapy, chemotherapy, and/or treatment with other investigational agents at least 3 weeks prior to study entry.

6) 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.

7) Eastern Cooperative Oncology Group (ECOG) status of </= 2.

8) Life expectancy of > 3 months.

9) Laboratory data: a) Platelet count >/= 50,000 mm^3; b) Hemoglobin >/= 9.0 g/dL; c) Absolute neutrophil count >/= 1000/mm^3; d) ALT/AST </= 2.5 x the upper limit of normal (ULN); e) Total bilirubin </= 1.5 x ULN; f) Creatinine </= 1.5 mg/dL.

10) 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.

11) Ability to provide written informed consent.

Exclusion Criteria:1) 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.

2) History or clinical evidence of central nervous system (CNS) HL.

3) If patient has received allogeneic BMT, no evidence of active graft-versus-host disease (GVHD), and currently not receiving immunosuppressive therapy.

4) Received growth factor support or transfusions to achieve hematology entry criteria (platelets, hemoglobin, absolute neutrophis count)

5) Major surgery within 4 weeks prior to study entry.

6) Known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation.

7) 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.

8) Any serious active viral, bacterial, or systemic fungal infection prior to study enrollment.

9) Known positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg), or hepatitis C virus (HCV).

10) History of significant chronic or recurrent infections requiring treatment.

11) Receiving systemic steroids exceeding 10 mg prednisone or equivalent, or unstable on steroid medication, during the 3 weeks immediately preceding enrollment.

12) Pregnant or breast-feeding.

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Links
Registration Number: NCT00441818
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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