Completed

NCT Number: 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

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.

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Key information

Conditions

Advanced Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Institut Paoli-Calmettes

Marseille, 13008, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vinorelbine, Cyclophosphamide and Interferon alpha 2b

Drug

Level 1: Oral Vinorelbine (Navelbine®)20mg x 2/week; oral Cyclophosphamide (Endoxan®) 50mg/day; SC interferon alpha 2b (Introna®) 0.9 million IU x 3/week.

Level 2: Oral Vinorelbine (Navelbine®)20mg x 3/week; oral Cyclophosphamide (Endoxan®) 50mg/day;SC interferon alpha 2b (Introna®) 0.9 million IU x 3/week.

Level 3: Oral Vinorelbine (Navelbine®)20mg x 2/week; oral Cyclophosphamide (Endoxan®) 50mg/day; SC interferon alpha 2b (Introna®) 0.9 million IU x 5/week.

Level -1 (in case of toxicity at level 1): Oral Vinorelbine (Navelbine®)20mg x 2/week; oral Cyclophosphamide (Endoxan®) 50mg/every 2 days; SC interferon alpha 2b (Introna®) 0.9 million IU x 3/week .

Primary outcomes

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

Time frame: 6 weeks

Secondary outcomes

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

Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Official study title

Combination of Continuous Low Doses of Vinorelbine, Cyclophosphamide and Interferon Alpha 2b for Antiangiogenic/Antivascular Effect in Adult Advanced Neoplasm

Acronym: METRO1

Important dates

Study start: 2006
Primary completion: 2010
Study completion: 2011
First posted: May 27, 2009
Registry last updated: Jan 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.