Combination of Continuous Low Doses of Vinorelbine, Cyclophosphamide and Interferon Alpha 2b (" Metronomic Chemotherapy ") for Antiangiogenic and Antivascular Effect. Trial With Pharmacodynamic Study in Adult Advanced Neoplasm

Phase 1

Completed

• Conditions: Advanced Neoplasm

• Registration Number: NCT00908869
• Lead Sponsor: Institut Paoli-Calmettes

Brief Summary

Purpose:

This phase I trial estimates the antiangiogenic and antivascular effect of 4 different levels of continuous low doses of the combination of Vinorelbine, Cyclophosphamide and Interferon alpha 2b (" metronomic chemotherapy ")in adult advanced neoplasm.

This study is non randomized, monocentric, and with a pharmacodynamic part.

Primary objective:

Estimation of the toxicity of the combination of continuous low doses of Vinorelbine, Cyclophosphamide and Interferon alpha 2b.

Secondary objectives:

Estimation of the antiangiogenic and/or antivascular effect (VEGF measurement) in radiography (DEC-MRI), biology and immunohistochemistry of the treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2009-05-25
• Study First Submitted QC: 2009-05-26
• Study First Posted: 2009-05-27
• Primary Completion: 2010-05
• Study Completion: 2011-05
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-26
• Last Update Posted: 2012-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• patients aged from 18 and older,
• with metastatic or advanced solid tumor who received all standard treatments,
• who ended their chemotherapy or radiotherapy treatment within 4 weeks (6 weeks for mitocyne)prior entry in the study.
• All patients are included after being given written informed consent.

Exclusion Criteria

• patients with stable disease,
• history or presence of another cancer,
• contraindication to administer the treatment,
• contraindication to perform MRI,
• pregnancy or breast feeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Estimation of the toxicity of the combination of continuous low doses of Vinorelbine, Cyclophosphamide and Interferon alpha 2b.	6 weeks

Secondary Outcome Measures

Name	Time	Method
Estimation of the antiangiogenic and/or antivascular effect (VEGF measurement) in radiography (DEC-MRI), biology and immunohistochemistry of the treatment.	6 weeks

Trial Locations

Locations (1)

Institut Paoli-Calmettes; 🇫🇷 Marseille, France