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 (METRO1)

Institut Paoli-Calmettes

Status and phase: Completed; Phase 1

Conditions: Advanced Neoplasm

Treatments: Drug: Vinorelbine, Cyclophosphamide and Interferon alpha 2b

Study type: Interventional

Funder types: Other

Identifiers

NCT00908869

METRO1/IPC2005-001

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)