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Bevacizumab, Dacarbazine and Interferon-Alfa to Treat Metastatic Melanoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00308607
First Posted: March 29, 2006
Last Update Posted: April 3, 2009
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.
Information provided by:
University of Turku
  Purpose
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 Intervention Phase
Metastatic Melanoma Drug: Bevacizumab (Avastin) Drug: dacarbazine Drug: interferon-alfa-2a (Roferon-A) Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Turku:

Primary Outcome Measures:
  • Response rate according to RECIST criteria
  • Progression-free survival
  • Time to brain metastases
  • Overall survival

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

Enrollment: 27
Study Start Date: August 2005
Study Completion Date: April 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00308607


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

Responsible Party: Pia Vihinen, Turku University Hospital
ClinicalTrials.gov Identifier: NCT00308607     History of Changes
Other Study ID Numbers: ML 18580
First Submitted: March 28, 2006
First Posted: March 29, 2006
Last Update Posted: April 3, 2009
Last Verified: April 2009

Keywords provided by University of Turku:
melanoma
metastatic
bevacizumab

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