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

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).

Study Overview

• Status: Unknown
• Conditions: T Cell Lymphoma
• Intervention / Treatment: Drug: endostar and CHOP

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
• Enrollment (Anticipated): 15
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Haiyi Guo, MD; Phone Number: 5008 86(021)64175590; Email: guohaiyi@csco.org.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Cancer Hospital
      • Contact: Haiyi Guo, MD; Phone Number: 5008 86(021)64175590; Email: guohaiyi@csco.org.cn
      • Sub-Investigator: Haiyi Guo, MD
      • Principal Investigator: Junning Cao, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: endostar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
efficacy include overall response rate, disease free survival and overall survival	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
safety of endostar combined with CHOP	1 year

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Junning Cao, MD, member of Fudan University Cancer Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Anticipated): September 1, 2010
• Study Completion (Anticipated): September 1, 2011

Study Registration Dates

• First Submitted: September 9, 2009
• First Submitted That Met QC Criteria: September 9, 2009
• First Posted (Estimate): September 10, 2009

Study Record Updates

• Last Update Posted (Estimate): September 15, 2010
• Last Update Submitted That Met QC Criteria: September 14, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: chemotherapy; peripheral T cell lymphoma; anti-angiogeneses
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Endostar protein
• Other Study ID Numbers: PTCL0908