Endostar Combined With CHOP Regimen as First Line Chemotherapy for Peripheral T Cell Lymphoma (PTCL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00974324
Recruitment Status : Unknown
Verified September 2010 by Fudan University.
Recruitment status was:  Recruiting
First Posted : September 10, 2009
Last Update Posted : September 15, 2010
Information provided by:
Fudan University

Brief Summary:
The role of angiogenesis has been less clear in lymphoma than in solid tumors, in part related to the heterogeneity of disease and technical issues. In addition to vascular endothelial growth factor (VEGF) effects on angiogenesis and the integrity of tumor vasculature, autocrine VEGF-receptor (VEGF-R)-mediated signaling may play a role in lymphoma. Microvessel density, a measure of angiogenesis, is highest in peripheral T-cell lymphomas (PTCL), followed by diffuse large B-cell (DLBCL) and intra-follicular follicular lymphoma (FL).

Condition or disease Intervention/treatment Phase
T Cell Lymphoma Drug: endostar and CHOP Phase 2

Detailed Description:
To investigate efficacy and safety of endostar combined with CHOP regimen as first line treatment for peripheral T cell lymphoma.The second subject is to clarify the association between expression of VEGF and prognosis in peripheral T cell lymphoma,unspecified(PTCL-U) and angioimmunoblastic T-cellLymphoma(AILT).Methods 15 cases of PTCL were enrolled in this study.Immunohistochemical staining was performed by EnVision method using antibodies VEGF.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Endostar Combined With CHOP Regimen as the First Line Chemotherapy for Untreated Peripheral T Cell Lymphoma
Study Start Date : August 2009
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: treatment
endostar combined with CHOP regimen
Drug: endostar and CHOP

endostar, 7.5m g/m2, intravenous, Day 2-15, repeat every 3 weeks

CHOP: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone

Other Name: endostar

Primary Outcome Measures :
  1. efficacy include overall response rate, disease free survival and overall survival [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. safety of endostar combined with CHOP [ Time Frame: 1 year ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Disease Characteristics:

    • Diagnosis of peripheral T-cell:

      • Any stage disease allowed
    • At least 1 objective measurable disease parameter
    • No anaplastic lymphoma kinase (ALK)-positive T-cell large cell lymphoma

      • ALK-negative T-cell large cell lymphoma allowed
    • No cutaneous T-cell lymphoma

      • No sezary syndrome
      • No NK/T cell lymphoma
    • No history of or current radiographic evidence of CNS metastasis, including previously treated, resected, or asymptomatic brain lesions or leptomeningeal involvement
  • Patient Characteristics:

    • Age:

      • 18 -75 years
    • Performance status:

      • ECOG 0-2
    • Life expectancy:

      • No less than 12 weeks
    • Hematopoietic:

      • Absolute neutrophil count ≥ 1,500/mm^3
      • Hemoglobulin ≥ 80*10^12/L
      • Platelet count ≥ 100,000/mm^3
      • No evidence of bleeding diathesis or coagulopathy
    • Hepatic:

      • Bilirubin ≤ 1.5 mg/dL
      • AST ≤ 2.5 times ULN
      • PT, INR, and PTT ≤ 1.5 times normal
    • Renal:

      • Creatinine ≤ 1.5 times normal
    • Cardiovascular:

      • No cerebrovascular accident within the past 6 months
      • No myocardial infarction within the past 6 months
      • No unstable angina within the past 6 months
      • No New York Heart Association class II-IV congestive heart failure
      • No uncontrolled hypertension (i.e., systolic blood pressure [BP] > 150 mm Hg or diastolic BP > 100 mm Hg)
      • No other clinically significant cardiovascular or peripheral vascular disease
      • LVEF is normal
    • Other:

      • Not pregnant or nursing
      • Fertile patients must use effective contraception
      • No history of active seizures
      • No non-healing ulcer (unless involved with lymphoma)
      • No active infection requiring parenteral antibiotics
      • No known HIV positivity
      • No other active malignancy within the past 6 months except carcinoma in situ of the cervix or basal cell carcinoma of the skin

    • Biologic therapy:

      • Not specified
    • Chemotherapy:

      • No prior chemotherapy was allowed
    • Surgery:

      • More than 4 weeks since prior major invasive surgery or open biopsy
      • At least 7 days since prior minor surgery
      • No concurrent major surgery

Exclusion Criteria:

  • Prior treatment included chemotherapy and radiotherapy
  • With the following risk factors: Uncontrolled or severe cardiovascular disease (e.g., myocardial infarction within the past 6 months, congestive heart failure treated with medications, or uncontrolled hypertension)
  • Pregnant or nursing
  • Other currently active malignancy except nonmelanoma skin cancer
  • Uncontrolled or severe bleeding,diarrhea,intestinal obstruction
  • Hypersensitivity to albumen

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00974324

Contact: Haiyi Guo, MD 86(021)64175590 ext 5008

China, Shanghai
Fudan University Cancer Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Haiyi Guo, MD    86(021)64175590 ext 5008   
Sub-Investigator: Haiyi Guo, MD         
Principal Investigator: Junning Cao, MD         
Sponsors and Collaborators
Fudan University
Principal Investigator: Junning Cao, MD Member of Fudan University Cancer Hospital

Responsible Party: Haiyi Guo, Medical Oncology of Fudan University Cancer Hospital Identifier: NCT00974324     History of Changes
Other Study ID Numbers: PTCL0908
First Posted: September 10, 2009    Key Record Dates
Last Update Posted: September 15, 2010
Last Verified: September 2010

Keywords provided by Fudan University:
peripheral T cell lymphoma

Additional relevant MeSH terms:
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin