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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Fudan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00974324
First received: September 9, 2009
Last updated: September 14, 2010
Last verified: September 2010
  Purpose

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 Intervention Phase
T Cell Lymphoma
Drug: endostar and CHOP
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • efficacy include overall response rate, disease free survival and overall survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • safety of endostar combined with CHOP [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: August 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00974324

Contacts
Contact: Haiyi Guo, MD 86(021)64175590 ext 5008 guohaiyi@csco.org.cn

Locations
China, Shanghai
Fudan University Cancer Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Haiyi Guo, MD    86(021)64175590 ext 5008    guohaiyi@csco.org.cn   
Sub-Investigator: Haiyi Guo, MD         
Principal Investigator: Junning Cao, MD         
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Junning Cao, MD Member of Fudan University Cancer Hospital
  More Information

No publications provided

Responsible Party: Haiyi Guo, Medical Oncology of Fudan University Cancer Hospital
ClinicalTrials.gov Identifier: NCT00974324     History of Changes
Other Study ID Numbers: PTCL0908
Study First Received: September 9, 2009
Last Updated: September 14, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Fudan University:
peripheral T cell lymphoma
chemotherapy
anti-angiogeneses

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

ClinicalTrials.gov processed this record on April 23, 2014