MelanomaPhase 2NCT00099970
Volociximab in Combination With DTIC in Patients With Metastatic Melanoma Not Previously Treated With Chemotherapy
A Phase 2 study testing M200 (volociximab) in Combination with Dacarbazine (DTIC) in people with Melanoma and Metastases, run by PDL BioPharma, Inc. at 7 sites in United States.
Trial summary
This clinical trial is being conducted to determine tumor response and preliminary safety of a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) that is required for the establishment of new blood vessels during tumor growth, a process known as angiogenesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Metastases
- What is being tested?
- M200 (volociximab) in Combination with Dacarbazine (DTIC)
- How many people
- 40 participants
- Where
- 7 sitesUnited States
- Study dates
- Dec 2004to Mar 2006
- 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
- Males and females of at least 18 years of age with stage IV or unresectable stage III non-ocular melanoma who may have received 0 to 2 prior regimens for metastatic disease with a biological therapy or immunotherapy (e.g., IL-2 or interferon-alfa).
- Measurable disease according to Response Criteria for Solid Tumors (RECIST).
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1.
- Estimated survival is greater or equal to 4 months.
- Negative pregnancy test (women of childbearing potential only).
- Pretreatment laboratory levels that meet specific criteria.
- Signed informed consent, including permission to use protected health information.
Who cannot join
- Prior treatment with M200 or a5b1 inhibitors and murine or chimeric monoclonal antibodies.
- Prior treatment with DTIC, temozolomide, or other chemotherapeutic regimens.
- Known sensitivity to murine proteins or chimeric antibodies or other components of the product.
- Use of any investigational drug within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer).
- Systemic biologic, immunotherapy, and/or radiation therapy within 4 weeks of the first dose of M200.
- Documented central nervous system (CNS) tumor or CNS metastasis.
- History of thromboembolic events and bleeding disorders within the past year.
- Medical conditions that may be exacerbated by bleeding.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Alabama at Birmingham-Comprehensive Cancer Ctr.
Birmingham, Alabama, 35294-3300
MD Anderson Cancer Center
Houston, Texas, 77030
UCLA School of Medicine
Los Angeles, California, 90095
University of Pittsburgh
Pittsburgh, Pennsylvania
Cancer Institute Medical Group, Inc.
Santa Monica, California, 90404
Palmetto Hematology Oncology, P.C.
Spartanburg, South Carolina, 29303
Arizona Cancer Center
Tucson, Arizona, 85724
About this study
Official title: Phase II Open-Label Study of Volociximab in Combination With DTIC in Patients With Metastatic Melanoma Not Previously Treated With Chemo
This clinical trial is being conducted to determine tumor response and preliminary safety of a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) that is required for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.
- Conditions
- Melanoma, Metastases
- Being tested
- M200 (volociximab) in Combination with Dacarbazine (DTIC)
- Keywords
- Solid tumors, Metastatic melanoma
- 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.
M200 (volociximab) in Combination with Dacarbazine (DTIC)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a confirmed tumor response at any time during the study.
Secondary outcomes (4)
Time to disease progression
Duration of tumor response
Pharmacokinetics (PK)
Immunogenicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2004 (estimated)
- Study startDec 2004
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 40 participants
Sponsor and investigators
- Lead sponsor
- PDL BioPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Steven J. O'Day, M.D., Principal investigator, Cancer Institute Medical Group, Inc.John Kirkwood, M.D., Principal investigator, University of PittsburghAgop Y. Bedikian, MD, Principal investigator, M.D. Anderson Cancer CenterAntoni Ribas, MD, Principal investigator, University of California, Los AngelesColin P. Curran, M.D., Principal investigator, Palmetto Hematology Oncology, P.C.Andres Forero, M.D., Principal investigator, University of Alabama at BirminghamLee Cranmer, M.D., Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00099970
- Sponsor's protocol ID
- M200-1203
- Status last verified
- Aug 2008
- First submitted
- 21 Dec 2004
- Last updated
- 5 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Open-Label Study of Volociximab in Combination With DTIC in Patients With Metastatic Melanoma Not Previously Treated With Chemo
- ClinicalTrials.gov ID
- NCT00099970
- Acronym / sponsor ID
- M200-1203
- Conditions
- Melanoma, Metastases
- Keywords
- Solid tumors, Metastatic melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- PDL BioPharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2004
- Study completion
- Mar 2006
- First posted
- 22 Dec 2004 (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.
This clinical trial is being conducted to determine tumor response and preliminary safety of a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) that is required for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.
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 (7 listed)
- Males and females of at least 18 years of age with stage IV or unresectable stage III non-ocular melanoma who may have received 0 to 2 prior regimens for metastatic disease with a biological therapy or immunotherapy (e.g., IL-2 or interferon-alfa).
- Measurable disease according to Response Criteria for Solid Tumors (RECIST).
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1.
- Estimated survival is greater or equal to 4 months.
- Negative pregnancy test (women of childbearing potential only).
Key exclusion criteria (8 listed)
- Prior treatment with M200 or a5b1 inhibitors and murine or chimeric monoclonal antibodies.
- Prior treatment with DTIC, temozolomide, or other chemotherapeutic regimens.
- Known sensitivity to murine proteins or chimeric antibodies or other components of the product.
- Use of any investigational drug within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer).
- Systemic biologic, immunotherapy, and/or radiation therapy within 4 weeks of the first dose of M200.
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 |
|---|---|---|
| M200 (volociximab) in Combination with Dacarbazine (DTIC) | Drug | – |
Primary outcome
Proportion of patients with a confirmed tumor response at any time during the study.
4 secondary outcomes
Time to disease progression
Duration of tumor response
Pharmacokinetics (PK)
Immunogenicity
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 5 Aug 2008.
Related trials for 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
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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
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.
Steven J. O'Day, M.D. principal investigator
Cancer Institute Medical Group, Inc.
John Kirkwood, M.D. principal investigator
University of Pittsburgh
Agop Y. Bedikian, MD principal investigator
M.D. Anderson Cancer Center
7 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 M200 (volociximab) in Combination with Dacarbazine (DTIC) in people with Melanoma and Metastases, run by PDL BioPharma, Inc. at 7 sites in United States.
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 7 inclusion and 8 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 5 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
Proportion of patients with a confirmed tumor response at any time during the study.. 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 5 Aug 2008; AzTrials last refreshed its copy on 8 Nov 2026.