Bevacizumab, Dacarbazine and Interferon-Alfa to Treat Metastatic Melanoma

NCT ID: NCT00308607

Last Updated: 2009-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2009-04-30

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.

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.

Conditions

Metastatic Melanoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Bevacizumab (Avastin)

Intervention Type: DRUG

dacarbazine

Intervention Type: DRUG

interferon-alfa-2a (Roferon-A)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Turku

OTHER

Sponsor Role: lead

Responsible Party

Turku University Hospital

Principal Investigators

Pia P Vihinen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Kuopio University Hospital

Kuopio, Kuopio, Finland

Oulu University Hospital

Oulu, Oulu, Finland

Tampere University Hospital

Tampere, Pirkanmaa, Finland

Countries

Finland

Other Identifiers

ML 18580

Identifier Type: -

Identifier Source: org_study_id