Bevacizumab, Dacarbazine and Interferon-Alfa to Treat Metastatic Melanoma

Metastatic Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00308607
• Other study ID #: ML 18580
• Status: Completed
• Phase: Phase 2
• First received: March 28, 2006
• Last updated: April 2, 2009
• Start date: August 2005
• Est. completion date: April 2009

Study information

• Verified date: April 2009
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma

Intervention

Drug:
• Bevacizumab (Avastin)

• dacarbazine

• interferon-alfa-2a (Roferon-A)

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio
Finland	Oulu University Hospital	Oulu
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate according to RECIST criteria
Primary	Progression-free survival
Primary	Time to brain metastases
Primary	Overall survival
Secondary	To evaluate safety of this combination after every two cycles
Secondary	Serum analysis of particular biochemical markers