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Bevacizumab, Dacarbazine and Interferon-Alfa to Treat Metastatic Melanoma

This study has been completed.
Sponsor:
Information provided by:
University of Turku
ClinicalTrials.gov Identifier:
NCT00308607
First received: March 28, 2006
Last updated: April 2, 2009
Last verified: April 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Melanoma
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Pia Vihinen, Turku University Hospital
ClinicalTrials.gov Identifier: NCT00308607     History of Changes
Other Study ID Numbers: ML 18580
Study First Received: March 28, 2006
Last Updated: April 2, 2009
Health Authority: Finland: Finnish Medicines Agency

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
Interferon-alpha
Interferon Alfa-2a
Interferons
Bevacizumab
Dacarbazine
Antiviral Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013