Endostar Combined With CHOP Regimen as First Line Chemotherapy for Peripheral T Cell Lymphoma (PTCL)
Primary Purpose
T Cell Lymphoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
endostar and CHOP
Sponsored by
About this trial
This is an interventional treatment trial for T Cell Lymphoma focused on measuring peripheral T cell lymphoma, chemotherapy, anti-angiogeneses
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
Sites / Locations
- Fudan University Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treatment
Arm Description
endostar combined with CHOP regimen
Outcomes
Primary Outcome Measures
efficacy include overall response rate, disease free survival and overall survival
Secondary Outcome Measures
safety of endostar combined with CHOP
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00974324
Brief Title
Endostar Combined With CHOP Regimen as First Line Chemotherapy for Peripheral T Cell Lymphoma
Acronym
PTCL
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
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
September 2010 (Anticipated)
Study Completion Date
September 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T Cell Lymphoma
Keywords
peripheral T cell lymphoma, chemotherapy, anti-angiogeneses
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment
Arm Type
Experimental
Arm Description
endostar combined with CHOP regimen
Intervention Type
Drug
Intervention Name(s)
endostar and CHOP
Other Intervention Name(s)
endostar
Intervention Description
endostar, 7.5m g/m2, intravenous, Day 2-15, repeat every 3 weeks
CHOP: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone
Primary Outcome Measure Information:
Title
efficacy include overall response rate, disease free survival and overall survival
Time Frame
1 year
Secondary Outcome Measure Information:
Title
safety of endostar combined with CHOP
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haiyi Guo, MD
Phone
86(021)64175590
Ext
5008
Email
guohaiyi@csco.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junning Cao, MD
Organizational Affiliation
Member of Fudan University Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haiyi Guo, MD
Phone
86(021)64175590
Ext
5008
Email
guohaiyi@csco.org.cn
First Name & Middle Initial & Last Name & Degree
Haiyi Guo, MD
First Name & Middle Initial & Last Name & Degree
Junning Cao, MD
12. IPD Sharing Statement
Learn more about this trial
Endostar Combined With CHOP Regimen as First Line Chemotherapy for Peripheral T Cell Lymphoma
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