Clinical trial NCT00974324: Endostar Combined With CHOP Regimen as First Line Chemotherapy for Peripheral T Cell Lymphoma
Official title: Phase 2 Study of Endostar Combined With CHOP Regimen as the First Line Chemotherapy for Untreated Peripheral T Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: T Cell Lymphoma
Keywords: peripheral T cell lymphoma
chemotherapy
anti-angiogeneses
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2009-09-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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 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

Primary outcomes:
measure: efficacy include overall response rate, disease free survival and overall survival
timeFrame: 1 year
Secondary outcomes:
measure: safety of endostar combined with CHOP
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: Member of Fudan University Cancer Hospital
name: Junning Cao, MD
role: PRINCIPAL_INVESTIGATOR
References: