Metastatic MelanomaPhase 2NCT01416844
Study of Immune Responses in Patients With Metastatic Melanoma
A Phase 2 study testing anti-OX40 in people with Metastatic Melanoma, run by Providence Health & Services at 1 site in United States.
Trial summary
In this study, anti-OX40 will be given to patients with melanoma to find out how the immune system responds to treatment with anti-OX40. It is hoped that this treatment will cause an immune response against melanoma resulting in tumor regression, but this is not known at this time. 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?
- anti-OX40
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Sep 2012
- 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
- Patients with measurable or evaluable unresectable, stage IV metastatic melanoma. Either histologic or cytologic diagnosis is acceptable.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, or 1 (Appendix A.)
- Age 18 years or above.
- Laboratory values (performed within 28 days prior to enrollment) as follows:
- WBC ≥2000/microliter
- Absolute lymphocyte count >300/mm3
Show all 22Show fewer
- Serum creatinine <1.5 X upper limit of laboratory normal
- Hgb >8g/dl (patients may be transfused to reach this level)
- Hct > 24%
- Platelets >100,000 cells/mm3
- Total bilirubin <1.5 X upper limit of laboratory normal, unless due to Gilbert's disease
- AST (SGOT)/ALT (SGPT) <2.5 X upper limit of laboratory normal
- Alkaline phosphatase <2.5 X upper limit of laboratory normal
- HIV Negative
- Hepatitis B surface antigen Negative
- Hepatitis C antibody Negative
- Women of childbearing potential must have a negative pregnancy test and must avoid becoming pregnant while on treatment. Men must avoid fathering a child while on treatment. This exclusion is required due to the unknown toxicities that anti-OX40 may have on the forming fetus, spermatogenesis or the nursing child. Also, because pregnancy may impair immune function it may limit the treatment efficacy.
- Ability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy.
- No active bleeding.
- No clinical coagulopathy (INR <1.5, PT <16 seconds, PTT < 38 seconds).
- Anticipated lifespan greater than 12 weeks.
- Failed at least one prior medical therapy for metastatic melanoma.
Who cannot join
- Active infection.
- History of or active autoimmune disease.
- Prior mouse monoclonal antibody treatment.
- Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.
- Need for chronic maintenance oral steroids.
- Active brain metastatic disease. Treated brain metastases with surgery, gamma-knife radiosurgery and/or whole brain radiation and stable for at least 4 weeks and off steroids are eligible.
- Any medical or psychiatric condition that in the opinion of the PI would preclude compliance with study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence Portland Medical Center
Portland, Oregon, 97213
About this study
Official title: Phase II Exploratory Study of Immune Responses in Patients With Metastatic Melanoma Treated With Mouse Monoclonal Anti-OX40
In this study, anti-OX40 will be given to patients with melanoma to find out how the immune system responds to treatment with anti-OX40. It is hoped that this treatment will cause an immune response against melanoma resulting in tumor regression, but this is not known at this time. Anti-OX40 is a large protein that can help immune cells that fight bacteria, viruses and cancer cells.
- Conditions
- Metastatic Melanoma
- Being tested
- anti-OX40
- Keywords
- Metastatic melanoma, anti-OX40, Immunostimulatory
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-OX40Biological
Patients with metastatic melanoma will be given 0.4 mg/kg anti-OX40 on days 1, 3 and 5 of a single treatment cycle.
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased number of tumor antigen specific circulating T Cells
T Cells will be harvested by apheresis at baseline and Day 15 following anti-OX40 administration.
Measured: Screening (baseline) and Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study startSep 2012
- Primary completionSep 2012
- Study completionSep 2012
Why it stopped: Change in the development plan for the anti-OX40 antibody.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brendan D Curti, MD, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416844
- Sponsor's protocol ID
- PH&S IRB 10-090
- Status last verified
- Mar 2013
- First submitted
- 12 Aug 2011
- Last updated
- 7 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Exploratory Study of Immune Responses in Patients With Metastatic Melanoma Treated With Mouse Monoclonal Anti-OX40
- ClinicalTrials.gov ID
- NCT01416844
- Acronym / sponsor ID
- PH&S IRB 10-090
- Conditions
- Metastatic Melanoma
- Keywords
- Metastatic melanoma, anti-OX40, Immunostimulatory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in the development plan for the anti-OX40 antibody.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 15 Aug 2011 (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.
In this study, anti-OX40 will be given to patients with melanoma to find out how the immune system responds to treatment with anti-OX40. It is hoped that this treatment will cause an immune response against melanoma resulting in tumor regression, but this is not known at this time. Anti-OX40 is a large protein that can help immune cells that fight bacteria, viruses and cancer cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- 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 (22 listed)
- Patients with measurable or evaluable unresectable, stage IV metastatic melanoma. Either histologic or cytologic diagnosis is acceptable.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, or 1 (Appendix A.)
- Age 18 years or above.
- Laboratory values (performed within 28 days prior to enrollment) as follows:
- Women of childbearing potential must have a negative pregnancy test and must avoid becoming pregnant while on treatment. Men must avoid fathering a child while on treatment. This exclusion is required due to the unknown toxicities that anti-OX40 may have on the forming fetus, spermatogenesis or the nursing child. Also, because pregnancy may impair immune function it may limit the treatment efficacy.
Key exclusion criteria (7 listed)
- Active infection.
- History of or active autoimmune disease.
- Prior mouse monoclonal antibody treatment.
- Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.
- Need for chronic maintenance oral steroids.
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 |
|---|---|---|
| anti-OX40Patients with metastatic melanoma will be given 0.4 mg/kg anti-OX40 on days 1, 3 and 5 of a single treatment cycle. | Biological | – |
Primary outcome
Increased number of tumor antigen specific circulating T Cells
Time frame: Screening (baseline) and Day 15
T Cells will be harvested by apheresis at baseline and Day 15 following anti-OX40 administration.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2013.
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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.
Brendan D Curti, MD principal investigator
Providence Health & Services
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 anti-OX40 in people with Metastatic Melanoma, run by Providence Health & Services at 1 site 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 22 inclusion and 7 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: withdrawn, as of the sponsor's last update on 7 Mar 2013. 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Increased number of tumor antigen specific circulating T Cells (time frame: Screening (baseline) and Day 15). 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 7 Mar 2013.