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

NCT00974324 | Unknown Phase 2 DMC

• 1 other identifier: PTCL0908
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

T Cell Lymphoma

Keywords

peripheral T cell lymphoma; chemotherapy; anti-angiogeneses

Outcome Measures

Primary Outcomes (1)

• efficacy include overall response rate, disease free survival and overall survival

  1 year

Secondary Outcomes (1)

• safety of endostar combined with CHOP

  1 year

Study Arms (1)

treatment

EXPERIMENTAL

endostar combined with CHOP regimen

Drug: endostar and CHOP

Interventions

endostar and CHOP DRUG

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

Also known as: endostar

treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• years
• Performance status:
• ECOG 0-2

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral

Interventions

endostar protein

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Junning Cao, MD

  Member of Fudan University Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haiyi Guo, MD

CONTACT

86(021)64175590; guohaiyi@csco.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2009
• First Posted: September 10, 2009
• Study Start: August 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2011
• Last Updated: September 15, 2010

Record last verified: 2010-09

Locations

CN (1)