Bevacizumab, Dacarbazine and Interferon-Alfa to Treat Metastatic Melanoma

April 2, 2009 updated by: University of Turku

Bevacizumab, Dacarbazine and Interferon Alfa-2a Combination as a First-Line Therapy in Patients With Locally Advancing or Metastatic Melanoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dacarbazine (DTIC) has been approved for treating metastatic melanoma in the 1970s, and after that numerous schedules and dacarbazine-based combinations have been studied in this disease. DTIC as a single agent gives a response rate of only 20%, but there have been efforts to improve this poor result by using DTIC in different combinations.Treatment of melanoma with combination chemotherapy and interferon-α (IFN-α) has given 50-60% response rates,but increase in the overall survival time has not been reached in controlled phase III studies. Thus, standard reference therapy in treatment of metastatic melanoma still is single dacarbazine or its combination with s.c. IFN-α. In addition, new studies with melanoma cells in vitro show that dacarbazine causes transcriptional up-regulation of vascular endothelial growth factor (VEGF), suggesting a potential clinical benefit of combination of DTIC and anti-VEGF therapy. IFN-α has been used in adjuvant therapy and in treatment of metastatic melanoma. IFN-α exerts its effects through antiproliferative, apoptosis-inducing and particularly antiangiogenic effects in addition to immunologic modulation.

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

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Kuopio, Finland, FIN-70211
        • Kuopio University Hospital
      • Oulu, Finland, FIN-90029
        • Oulu University Hospital
      • Tampere, Finland, FIN-33521
        • Tampere University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Progression-free survival
Overall survival
Response rate according to RECIST criteria
Time to brain metastases

Secondary Outcome Measures

Outcome Measure
To evaluate safety of this combination after every two cycles
Serum analysis of particular biochemical markers

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turku

Investigators

  • Principal Investigator: Pia P Vihinen, MD, PhD, Turku University Hospital, Department of Oncology and Radiotherapy, Savitehtaankatu 1, FIN-20520 Turku, Finland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

March 28, 2006

First Submitted That Met QC Criteria

March 28, 2006

First Posted (Estimate)

March 29, 2006

Study Record Updates

Last Update Posted (Estimate)

April 3, 2009

Last Update Submitted That Met QC Criteria

April 2, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML 18580

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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