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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00908869

Acronym

METRO1

Enrollment

Registered

2009-05-27

Start date

2006-05-31

Completion date

2011-05-31

Last updated

2012-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Neoplasm

Keywords

advanced neoplasm, adult advanced neoplasm

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.

Interventions

DRUGVinorelbine, Cyclophosphamide and Interferon alpha 2b

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 .

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026