drugset / Trial / NCT00908869
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
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2006-05
- Primary completion
- 2010-05
- Completion
- 2011-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 50 mg | Oral |
| Subject | Vinorelbine | Small molecule | 20 mg | Oral |
| Subject | interferon alfa-2b | Protein / enzyme biologic | 900000 iu | Subcutaneous |