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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:
NCT00908869
First received: May 25, 2009
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Advanced Neoplasm
Drug: Vinorelbine, Cyclophosphamide and Interferon alpha 2b
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Institut Paoli-Calmettes:

Primary Outcome Measures:
  • Estimation of the toxicity of the combination of continuous low doses of Vinorelbine, Cyclophosphamide and Interferon alpha 2b. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Estimation of the antiangiogenic and/or antivascular effect (VEGF measurement) in radiography (DEC-MRI), biology and immunohistochemistry of the treatment. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: May 2006
Study Completion Date: May 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
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 .

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00908869

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

Additional Information:
No publications provided

Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT00908869     History of Changes
Other Study ID Numbers: METRO1/IPC2005-001
Study First Received: May 25, 2009
Last Updated: January 26, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on August 28, 2014