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

T Cell Lymphoma Clinical Trial

— PTCL  

Official title:

Phase 2 Study of Endostar Combined With CHOP Regimen as the First Line Chemotherapy for Untreated Peripheral T Cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00974324
• Other study ID #: PTCL0908
• Status: Recruiting
• Phase: Phase 2
• First received: September 9, 2009
• Last updated: September 14, 2010
• Start date: August 2009
• Est. completion date: September 2011

Study information

• Verified date: September 2010
• Source: Fudan University
• Contact: Haiyi Guo, MD
• Phone: 86(021)64175590
• Email: guohaiyi[@]csco.org.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• T Cell Lymphoma

Intervention

Drug:
• endostar and CHOP
endostar, 7.5m g/m2, intravenous, Day 2-15, repeat every 3 weeks CHOP: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy include overall response rate, disease free survival and overall survival		1 year	Yes
Secondary	safety of endostar combined with CHOP		1 year	Yes