Metastatic MelanomaPhase 2NCT00139360
Efficacy of Bevacizumab Monotherapy in Treatment of Metastatic Melanoma
A Phase 2 study testing Bevacizumab in people with Metastatic Melanoma, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
To determine the efficacy as measured by objective tumor response of first-line treatment of metastatic melanoma with bevacizumab monotherapy 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteNorway
- Study dates
- May 2005to Jul 2011
- 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 metastatic (unresectable) melanoma and with progressive disease
- WHO performance status 0-2
- Age >18 years
- Able to undergo outpatient treatment
- Patients must have clinically and/or radiographically documented measurable disease according to RECIST criteria
- At least 4 weeks since adjuvant interferon alpha
Show all 11Show fewer
- Recovered from prior chemotherapy
- Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start. Biopsy or fine needle aspiration within 5 days prior to study treatment start. Central venous line placement must be inserted at least 5 days prior to treatment start.
- Minimum required laboratory data:
- Hematology: absolute granulocytes > 1.0 x 109/L platelets > 100 x 109/L Biochemistry: bilirubin < 1.5 x upper normal limit serum creatinine within normal limits INR < 1.5
- Before patient registration/randomization, written informed consent must be given according to national and local regulations.
Who cannot join
- No pregnant or lactating patients can be included
- No prior interferon alpha or IL-2 for metastatic disease
- No more than 1 prior chemotherapy regimen for metastatic disease
- No clinical evidence of coagulopathy
- No brain metastases
- No symptomatic congestive heart failure
Show all 13Show fewer
- No unstable angina pectoris
- No cardiac arrhythmia
- No history of thrombosis
- No full-dose oral coumarin-derived anticoagulants (INR>1.5) or heparin, thrombolytic agents, or chronic, daily treatment with aspirin (>325 mg/day)
- No non-steroidal anti-inflammatory medications (those known to inhibit platelet function at doses used to treat chronic inflammatory diseases)
- No uncontrolled hypertension
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Oncology, Haukeland University Hospital
Bergen, 5020
About this study
Official title: Efficacy of Bevacizumab Monotherapy in Treatment of Metastatic Melanoma and Predictive Value of Angiogenic Markers
To determine the efficacy as measured by objective tumor response of first-line treatment of metastatic melanoma with bevacizumab monotherapy
Read the detailed description
In Norway, cutaneous malignant melanoma is the second most frequent and the most frequent cancer type in middle-aged (30-54 years) females and males, respectively, and the incidence has six-doubled during the last 30 years. Median survival for patients with metastatic melanoma is 6 months.
Many agents have been investigated for anti-tumor effect in melanoma, but there is no accepted standard therapy. Biochemotherapy, combining cytotoxic drugs with Interleukin-2 or Interferon alpha, has not been shown to be superior to single agent Dacarbazine (DTIC), which is regarded to be the most active agent. Other biological approaches like vaccination are currently under investigation, but still no efficient treatment for metastatic melanoma is available. DTIC induces objective remission in 20% of the patients, but without significant impact on survival.
The need of a new and effective treatment for the group of melanoma patients is urgently needed. This will be the first study to assess response rates of bevacizumab monotherapy in first line treatment of metastatic melanoma. In addition there will be a major focus on the identification of predictive biomarkers of bevacizumab efficacy.
- Conditions
- Metastatic Melanoma
- Being tested
- Bevacizumab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Anti angiogenesis treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Active drug Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response rates
Measured: Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years.
Secondary outcomes (3)
Time to progression
Measured: Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years.
Overall survival
Measured: Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years.
Safety data
CTCAEv2 side effects
Measured: Evaluated by consultations every 12 weeks, later every 6 monts. Up to 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
- Study startMay 2005
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Cancer Society, Hoffmann-La Roche
- Responsible party
- Principal investigator, Oddbjørn Straume, MD PhD, Haukeland University Hospital
- Investigators
- Oddbjorn Straume, MD, PhD, Principal investigator, Department of Oncology, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00139360
- Sponsor's protocol ID
- NSD-11933
- Other IDs
- 94070/013
- Status last verified
- Aug 2015
- First submitted
- 30 Aug 2005
- Last updated
- 27 Aug 2015
- Results posted
- No
Publications
Schuster C, Akslen LA, Straume O. Expression of Heat Shock Protein 27 in Melanoma Metastases Is Associated with Overall Response to Bevacizumab Monotherapy: Analyses of Predictive Markers in a Clinical Phase II Study. PLoS One. 2016 May 11;11(5):e0155242. doi: 10.1371/journal.pone.0155242. eCollection 2016.
PubMed 27166673Schuster C, Eikesdal HP, Puntervoll H, Geisler J, Geisler S, Heinrich D, Molven A, Lonning PE, Akslen LA, Straume O. Clinical efficacy and safety of bevacizumab monotherapy in patients with metastatic melanoma: predictive importance of induced early hypertension. PLoS One. 2012;7(6):e38364. doi: 10.1371/journal.pone.0038364. Epub 2012 Jun 15.
PubMed 22719881
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Bevacizumab Monotherapy in Treatment of Metastatic Melanoma and Predictive Value of Angiogenic Markers
- ClinicalTrials.gov ID
- NCT00139360
- Acronym / sponsor ID
- NSD-11933
- Conditions
- Metastatic Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Norwegian Cancer Society, Hoffmann-La Roche
- Study start
- May 2005
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 31 Aug 2005 (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.
To determine the efficacy as measured by objective tumor response of first-line treatment of metastatic melanoma with bevacizumab monotherapy
Detailed description
In Norway, cutaneous malignant melanoma is the second most frequent and the most frequent cancer type in middle-aged (30-54 years) females and males, respectively, and the incidence has six-doubled during the last 30 years. Median survival for patients with metastatic melanoma is 6 months.
Many agents have been investigated for anti-tumor effect in melanoma, but there is no accepted standard therapy. Biochemotherapy, combining cytotoxic drugs with Interleukin-2 or Interferon alpha, has not been shown to be superior to single agent Dacarbazine (DTIC), which is regarded to be the most active agent. Other biological approaches like vaccination are currently under investigation, but still no efficient treatment for metastatic melanoma is available. DTIC induces objective remission in 20% of the patients, but without significant impact on survival.
The need of a new and effective treatment for the group of melanoma patients is urgently needed. This will be the first study to assess response rates of bevacizumab monotherapy in first line treatment of metastatic melanoma. In addition there will be a major focus on the identification of predictive biomarkers of bevacizumab efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: BevacizumabActive drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed metastatic (unresectable) melanoma and with progressive disease
- WHO performance status 0-2
- Age >18 years
- Able to undergo outpatient treatment
- Patients must have clinically and/or radiographically documented measurable disease according to RECIST criteria
Key exclusion criteria (13 listed)
- No pregnant or lactating patients can be included
- No prior interferon alpha or IL-2 for metastatic disease
- No more than 1 prior chemotherapy regimen for metastatic disease
- No clinical evidence of coagulopathy
- No brain metastases
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 |
|---|---|---|
| BevacizumabAnti angiogenesis treatment | Drug | 1 |
Primary outcome
Clinical Response rates
Time frame: Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years.
3 secondary outcomes
Time to progression
Time frame: Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years.
Overall survival
Time frame: Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years.
Safety data
Time frame: Evaluated by consultations every 12 weeks, later every 6 monts. Up to 10 years.
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 27 Aug 2015.
- Derived from this study: PubMed 27166673Schuster C, Akslen LA, Straume O. Expression of Heat Shock Protein 27 in Melanoma Metastases Is Associated with Overall Response to Bevacizumab Monotherapy: Analyses of Predictive Markers in a Clinical Phase II Study. PLoS One. 2016 May 11;11(5):e0155242. doi: 10.1371/journal.pone.0155242. eCollection 2016.
- Derived from this study: PubMed 22719881Schuster C, Eikesdal HP, Puntervoll H, Geisler J, Geisler S, Heinrich D, Molven A, Lonning PE, Akslen LA, Straume O. Clinical efficacy and safety of bevacizumab monotherapy in patients with metastatic melanoma: predictive importance of induced early hypertension. PLoS One. 2012;7(6):e38364. doi: 10.1371/journal.pone.0038364. Epub 2012 Jun 15.
Related trials for Metastatic Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
RecruitingPhase 3
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
Melanoma
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 1/2
A Study of ST-1898 for Unresectable or Metastatic Melanoma
Unresectable or Metastatic Melanoma
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.
Oddbjorn Straume, MD, PhD principal investigator
Department of Oncology, Haukeland University Hospital
1 site 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 in people with Metastatic Melanoma, run by Haukeland University Hospital at 1 site in Norway.
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 11 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 27 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
Clinical Response rates (time frame: Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00139360, which also lists 2 linked publications.
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 27 Aug 2015.