Metastatic MelanomaPhase 2NCT00308607
Bevacizumab, Dacarbazine and Interferon-Alfa to Treat Metastatic Melanoma
A Phase 2 study testing Bevacizumab (Avastin), dacarbazine and interferon-alfa-2a (Roferon-A) in people with Metastatic Melanoma, run by University of Turku at 3 sites in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- Bevacizumab (Avastin), dacarbazine and interferon-alfa-2a (Roferon-A)
- How many people
- 27 participants
- Where
- 3 sitesFinland
- Study dates
- Aug 2005to Apr 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Finland3 sites
Kuopio University Hospital
Kuopio, Kuopio, FIN-70211
Oulu University Hospital
Oulu, Oulu, FIN-90029
Tampere University Hospital
Tampere, Pirkanmaa, FIN-33521
About this study
Official title: Bevacizumab, Dacarbazine and Interferon Alfa-2a Combination as a First-Line Therapy in Patients With Locally Advancing or Metastatic Melanoma
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.
Read the 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
- Being tested
- Bevacizumab (Avastin), dacarbazine, interferon-alfa-2a (Roferon-A)
- Keywords
- melanoma, metastatic, bevacizumab
- Medical subject headings
- Melanoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab (Avastin)Drug
dacarbazineDrug
interferon-alfa-2a (Roferon-A)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate according to RECIST criteria
Progression-free survival
Time to brain metastases
Overall survival
Secondary outcomes (2)
To evaluate safety of this combination after every two cycles
Serum analysis of particular biochemical markers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2006 (estimated)
- Study startAug 2005
- Primary completionDec 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Investigators
- Pia P Vihinen, MD, PhD, Principal investigator, Turku University Hospital, Department of Oncology and Radiotherapy, Savitehtaankatu 1, FIN-20520 Turku, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308607
- Sponsor's protocol ID
- ML 18580
- Status last verified
- Apr 2009
- First submitted
- 28 Mar 2006
- Last updated
- 3 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bevacizumab, Dacarbazine and Interferon Alfa-2a Combination as a First-Line Therapy in Patients With Locally Advancing or Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00308607
- Acronym / sponsor ID
- ML 18580
- Conditions
- Metastatic Melanoma
- Keywords
- melanoma, metastatic, bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 29 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- unevaluable disease
- major surgery within 28 days prior to day 0
- uncompleted radiotherapy
- CNS metastases
- serious non-healing wound or ulcer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bevacizumab (Avastin) | Drug | – |
| dacarbazine | Drug | – |
| interferon-alfa-2a (Roferon-A) | Drug | – |
Primary outcome
Response rate according to RECIST criteria
Progression-free survival
Time to brain metastases
Overall survival
2 secondary outcomes
To evaluate safety of this combination after every two cycles
Serum analysis of particular biochemical markers
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pia P Vihinen, MD, PhD principal investigator
Turku University Hospital, Department of Oncology and Radiotherapy, Savitehtaankatu 1, FIN-20520 Turku, Finland
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab (Avastin), dacarbazine and interferon-alfa-2a (Roferon-A) in people with Metastatic Melanoma, run by University of Turku at 3 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate according to RECIST criteria. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2009.