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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by Fudan University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00974324
First Posted: September 10, 2009
Last Update Posted: September 15, 2010
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.
Information provided by:
Fudan University
September 9, 2009
September 10, 2009
September 15, 2010
August 2009
September 2010   (Final data collection date for primary outcome measure)
efficacy include overall response rate, disease free survival and overall survival [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT00974324 on ClinicalTrials.gov Archive Site
safety of endostar combined with CHOP [ Time Frame: 1 year ]
Same as current
Not Provided
Not Provided
 
Endostar Combined With CHOP Regimen as First Line Chemotherapy for Peripheral T Cell Lymphoma
Phase 2 Study of Endostar Combined With CHOP Regimen as the First Line Chemotherapy for Untreated Peripheral T Cell Lymphoma
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).
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.
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
T Cell Lymphoma
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
Experimental: treatment
endostar combined with CHOP regimen
Intervention: Drug: endostar and CHOP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
15
September 2011
September 2010   (Final data collection date for primary outcome measure)

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
  • PRIOR CONCURRENT THERAPY:

    • 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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00974324
PTCL0908
Yes
Not Provided
Not Provided
Haiyi Guo, Medical Oncology of Fudan University Cancer Hospital
Fudan University
Not Provided
Principal Investigator: Junning Cao, MD Member of Fudan University Cancer Hospital
Fudan University
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP