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

Phase 2
18 Years
Not Enrolling
Metastatic Melanoma

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Trial Information

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

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

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.

Inclusion Criteria:

- histologically confirmed malignant melanoma either locally progressing inoperable or

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate according to RECIST criteria

Principal Investigator

Pia P Vihinen, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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


Finland: Finnish Medicines Agency

Study ID:

ML 18580



Start Date:

August 2005

Completion Date:

April 2009

Related Keywords:

  • Metastatic Melanoma
  • melanoma
  • metastatic
  • bevacizumab
  • Melanoma