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

NCT ID: NCT00974324

Last Updated: 2010-09-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2011-09-30

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.

Conditions

T Cell Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment

endostar combined with CHOP regimen

Group Type: EXPERIMENTAL

endostar and CHOP

Intervention Type: DRUG

endostar, 7.5m g/m2, intravenous, Day 2-15, repeat every 3 weeks

CHOP: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone

Interventions

endostar and CHOP

endostar, 7.5m g/m2, intravenous, Day 2-15, repeat every 3 weeks

CHOP: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone

Intervention Type: DRUG

Other Intervention Names

endostar

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Medical Oncology of Fudan University Cancer Hospital

Principal Investigators

Junning Cao, MD

Role: PRINCIPAL_INVESTIGATOR

Member of Fudan University Cancer Hospital

Locations

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Haiyi Guo, MD

Role: CONTACT

guohaiyi@csco.org.cn

86(021)64175590 ext. 5008

Facility Contacts

Haiyi Guo, MD

Role: primary

guohaiyi@csco.org.cn

86(021)64175590 ext. 5008

Other Identifiers

PTCL0908

Identifier Type: -

Identifier Source: org_study_id