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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)

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ClinicalTrials.gov Identifier: NCT00908869
Recruitment Status : Completed
First Posted : May 27, 2009
Last Update Posted : January 30, 2012
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Advanced Neoplasm Drug: Vinorelbine, Cyclophosphamide and Interferon alpha 2b Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination of Continuous Low Doses of Vinorelbine, Cyclophosphamide and Interferon Alpha 2b for Antiangiogenic/Antivascular Effect in Adult Advanced Neoplasm
Study Start Date : May 2006
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2011



Intervention Details:
    Drug: Vinorelbine, 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 .



Primary Outcome Measures :
  1. Estimation of the toxicity of the combination of continuous low doses of Vinorelbine, Cyclophosphamide and Interferon alpha 2b. [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Estimation of the antiangiogenic and/or antivascular effect (VEGF measurement) in radiography (DEC-MRI), biology and immunohistochemistry of the treatment. [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908869


Locations
France
Institut Paoli-Calmettes
Marseille, France, 13008
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
Principal Investigator: Anthony GONCALVES, MD Institut Paoli-Calmettes

Additional Information:
Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT00908869     History of Changes
Other Study ID Numbers: METRO1/IPC2005-001
First Posted: May 27, 2009    Key Record Dates
Last Update Posted: January 30, 2012
Last Verified: January 2012

Keywords provided by Institut Paoli-Calmettes:
advanced neoplasm
adult advanced neoplasm

Additional relevant MeSH terms:
Neoplasms
Cyclophosphamide
Vinorelbine
Interferons
Vinblastine
Interferon-alpha
Angiogenesis Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors