Bevacizumab, Dacarbazine and Interferon-Alfa to Treat Metastatic Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00308607
Recruitment Status : Completed
First Posted : March 29, 2006
Last Update Posted : April 3, 2009
Information provided by:
University of Turku

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.

Condition or disease Intervention/treatment Phase
Metastatic Melanoma Drug: Bevacizumab (Avastin) Drug: dacarbazine Drug: interferon-alfa-2a (Roferon-A) Phase 2

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  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bevacizumab, Dacarbazine and Interferon Alfa-2a Combination as a First-Line Therapy in Patients With Locally Advancing or Metastatic Melanoma
Study Start Date : August 2005
Actual Primary Completion Date : December 2008
Actual Study Completion Date : April 2009

Primary Outcome Measures :
  1. Response rate according to RECIST criteria
  2. Progression-free survival
  3. Time to brain metastases
  4. Overall survival

Secondary Outcome Measures :
  1. To evaluate safety of this combination after every two cycles
  2. Serum analysis of particular biochemical markers

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

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

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 identifier (NCT number): NCT00308607

Kuopio University Hospital
Kuopio, Finland, FIN-70211
Oulu University Hospital
Oulu, Finland, FIN-90029
Tampere University Hospital
Tampere, Finland, FIN-33521
Sponsors and Collaborators
University of Turku
Principal Investigator: Pia P Vihinen, MD, PhD Turku University Hospital, Department of Oncology and Radiotherapy, Savitehtaankatu 1, FIN-20520 Turku, Finland

Responsible Party: Pia Vihinen, Turku University Hospital Identifier: NCT00308607     History of Changes
Other Study ID Numbers: ML 18580
First Posted: March 29, 2006    Key Record Dates
Last Update Posted: April 3, 2009
Last Verified: April 2009

Keywords provided by University of Turku:

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors