NCT00308607

Brief Summary

The purpose of this study is to determine whether combination therapy with bevacizumab (Avastin), dacarbazine and interferon-alfa-2a (Roferon-A) is effective in patients with locally advancing or metastatic melanoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2005

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

April 3, 2009

Status Verified

April 1, 2009

Enrollment Period

3.3 years

First QC Date

March 28, 2006

Last Update Submit

April 2, 2009

Conditions

Metastatic Melanoma

Keywords

melanomametastaticbevacizumab

Outcome Measures

Primary Outcomes (4)

  • Response rate according to RECIST criteria

  • Progression-free survival

  • Time to brain metastases

  • Overall survival

Secondary Outcomes (2)

  • To evaluate safety of this combination after every two cycles

  • Serum analysis of particular biochemical markers

Interventions

Bevacizumab (Avastin)DRUG
dacarbazineDRUG
interferon-alfa-2a (Roferon-A)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically confirmed malignant melanoma either locally progressing inoperable or metastatic
  • measurable/evaluable disease in accordance with RECIST criteria
  • WHO performance status 0-2
  • normal organ function
  • signed written informed consent

You may not qualify if:

  • unevaluable disease
  • major surgery within 28 days prior to day 0
  • uncompleted radiotherapy
  • CNS metastases
  • serious non-healing wound or ulcer
  • bleeding diathesis or coagulopathy
  • uncontrolled hypertension
  • clinically significant cardiovascular disease
  • depression or psychosis, which needs medication
  • ongoing treatment with aspirin (\>325 mg/day)
  • pregnancy
  • any other serious or uncontrolled illness
  • previous chemotherapy for metastatic melanoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kuopio University Hospital

Kuopio, Kuopio, FIN-70211, Finland

Location

Oulu University Hospital

Oulu, Oulu, FIN-90029, Finland

Location

Tampere University Hospital

Tampere, Pirkanmaa, FIN-33521, Finland

Location

MeSH Terms

Conditions

MelanomaNeoplasm Metastasis

Interventions

BevacizumabDacarbazineInterferon alpha-2

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsInterferon-alphaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesBiological Factors

Study Officials

  • Pia P Vihinen, MD, PhD

    Turku University Hospital, Department of Oncology and Radiotherapy, Savitehtaankatu 1, FIN-20520 Turku, Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 28, 2006

First Posted

March 29, 2006

Study Start

August 1, 2005

Primary Completion

December 1, 2008

Study Completion

April 1, 2009

Last Updated

April 3, 2009

Record last verified: 2009-04

Locations

FI(3)