Newly Diagnosed Melanoma Metastases in the Brain and SpinePhase 1NCT01950195
SRS (Stereotactic Radiosurgery) Plus Ipilimumab
A Phase 1 study testing Stereotactic Radiosurgery (SRS) and Ipilimumab in people with Newly Diagnosed Melanoma Metastases in the Brain and Spine, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
This research is being done to look at the safety of using stereotactic radiosurgery (SRS) and Ipilimumab together to treat melanoma that has spread to the brain or spine. Both Ipilimumab and SRS are used alone for the treatment of melanoma that has spread. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Newly Diagnosed Melanoma Metastases in the Brain and Spine
- What is being tested?
- Stereotactic Radiosurgery (SRS) and Ipilimumab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Sep 2016
- Phase
- Phase 1
- 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 must have histologically confirmed diagnosis of melanoma. The pathologic confirmation may be from another metastatic site or from metastatic brain or spine lesions.
- Patients must have Stage IV melanoma, with newly identified brain or spine metastases.
- Patients must have measurable lesion in the brain or spine that is > 3 mm seen on magnetic resonance imaging (MRI) with contrast.
- NOTE: Contrasted pre-treatment MRI scan must be obtained ≤ 21 days prior to stereotactic radiosurgery treatment.
- Karnofsky Performance Scale >70%
- Patients must have normal organ and marrow function as defined below:
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- leukocytes >3,000/mcL absolute neutrophil count >1,500/mcL platelets >100,000/mcL total bilirubin ≤2X institutional upper limit of normal AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal creatinine within normal institutional limits OR According to Johns Hopkins MRI policy
- Women of child bearing potential (WOCBP) using a reliable form of contraception during the study treatment period and for up to 12 weeks following the last dose of study drug [21].
- Men must agree to the use of male contraception during the study treatment period and for at least 12 weeks after the last dose of study drug.
- Ability to understand and the willingness to sign written informed consent document(s).
Who cannot join
- Prior whole brain radiation or conventional radiation to the spine at the site of new lesion.
- Prior chemotherapy within 28 days of starting treatment.
- Prior therapy with investigational drugs within 28 days or at least 5 half-lives (whichever is longer) before study administration.
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody.
- Neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Known allergy to compounds of similar chemical or biologic composition to ipilimumab.
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- Pregnant or breastfeeding women.
- Known history of Human Immunodeficiency Virus.
- Active infection requiring therapy, positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA) [11].
- Active autoimmune disease, history of autoimmune disease or history of syndrome that required systemic steroids or immunosuppressive medications. Exceptions include those with vitiligo or resolved childhood asthma/atopy. Subjects with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study [11].
- Use of any vaccines against infectious diseases (e.g. varicella, influenza, etc.) up to 4 weeks (28 days) before receiving ipilimumab.
- Prisoners or subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness.
- Patients with both brain and spine metastases will be excluded from the trial.
- Patients who are allergic to MRI contrast agent or have contraindication for MRI.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
About this study
Official title: A Pilot Study of Stereotactic Radiosurgery Combined With Ipilimumab in Patients With Newly Diagnosed Melanoma Metastases in the Brain and Spine
This research is being done to look at the safety of using stereotactic radiosurgery (SRS) and Ipilimumab together to treat melanoma that has spread to the brain or spine. Both Ipilimumab and SRS are used alone for the treatment of melanoma that has spread. Standard of care uses both of these treatments but not together. By using them together, we expect better treatment of melanoma, but there might be an increase in side effects.
"Ipilimumab" is approved by the Food and Drug Administration (FDA) for the treatment of melanoma that has spread throughout the body. It works by activating your immune system to fight off cancer.
Read more
"Stereotactic radiosurgery" (SRS) is approved by the Food and Drug Administration (FDA) for the treatment of melanoma in the brain or spine. It uses radiation to treat tumors without needing to cut or use stitches.
The use of combining SRS and Ipilimumab in this research study is investigational. The word "investigational" means that this combination is not approved for marketing by the Food and Drug Administration but is allowed for use in this research study.
- Being tested
- Stereotactic Radiosurgery (SRS), Ipilimumab
- Keywords
- Melanoma, Metastases, Brain, Spine, SRS(Stereotactic Radiosurgery)), Ipilimumab
- 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.
Stereotactic Radiosurgery (SRS)Procedure or surgery
IpilimumabBiological
| Study group | Role | What they receive |
|---|---|---|
| Brain | Experimental | A cohort of six (6) patients will be treated at Dosing Schedule 1. If the observed dose limiting toxicity (DLT) rate is less ≤33%, the dose cohort will be expended to a total of 15 patients. Brain and spine metastases will be evaluated as two separate cohorts.
If the first schedule produces DLTs in >33% of patients, the Second Dosing schedule will be implemented. If the second dosing schedule produces DLTs in >33% of patients, the Third Dosing schedule will be implemented.
After 6 patients were enrolled in a cohort, their safety and toxicity will be continuously monitored till 12 weeks (3 months) after the initial dose of Ipilimumab is given for evaluating dose-limiting toxicities. Receives: Procedure: Stereotactic Radiosurgery (SRS); Biological: Ipilimumab |
| Spine | Experimental | A cohort of six (6) patients will be treated at Dosing Schedule 1. If the observed dose limiting toxicity (DLT) rate is less ≤33%, the dose cohort will be expended to a total of 15 patients. Brain and spine metastases will be evaluated as two separate cohorts.
If the first schedule produces DLTs in >33% of patients, the Second Dosing schedule will be implemented. If the second dosing schedule produces DLTs in >33% of patients, the Third Dosing schedule will be implemented.
After 6 patients were enrolled in a cohort, their safety and toxicity will be continuously monitored till 12 weeks (3 months) after the initial dose of Ipilimumab is given for evaluating dose-limiting toxicities. Receives: Procedure: Stereotactic Radiosurgery (SRS); Biological: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events and severity of the adverse events.
To assess the safety profile of stereotactic radiosurgery with ipilimumab in combination to treat patients with newly diagnosed melanoma brain or spinal metastases.
Measured: 2 years
Secondary outcomes (1)
To estimate local control rate in brain and spine
To estimate systematic control rate; To estimate progression-free survival
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2016
Why it stopped: Local IRB required us to submit amendment as a separate study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed Melanoma Metastases in the Brain and SpineStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Lim, MD, Principal investigator, Johns Hopkins Department of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950195
- Sponsor's protocol ID
- J1382
- Status last verified
- Nov 2016
- First submitted
- 21 Jun 2013
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Stereotactic Radiosurgery Combined With Ipilimumab in Patients With Newly Diagnosed Melanoma Metastases in the Brain and Spine
- ClinicalTrials.gov ID
- NCT01950195
- Acronym / sponsor ID
- J1382
- Keywords
- Melanoma, Metastases, Brain, Spine, SRS(Stereotactic Radiosurgery)), Ipilimumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Local IRB required us to submit amendment as a separate study.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2016 (actual)
- First posted
- 25 Sep 2013 (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 research is being done to look at the safety of using stereotactic radiosurgery (SRS) and Ipilimumab together to treat melanoma that has spread to the brain or spine. Both Ipilimumab and SRS are used alone for the treatment of melanoma that has spread. Standard of care uses both of these treatments but not together. By using them together, we expect better treatment of melanoma, but there might be an increase in side effects.
"Ipilimumab" is approved by the Food and Drug Administration (FDA) for the treatment of melanoma that has spread throughout the body. It works by activating your immune system to fight off cancer.
"Stereotactic radiosurgery" (SRS) is approved by the Food and Drug Administration (FDA) for the treatment of melanoma in the brain or spine. It uses radiation to treat tumors without needing to cut or use stitches.
The use of combining SRS and Ipilimumab in this research study is investigational. The word "investigational" means that this combination is not approved for marketing by the Food and Drug Administration but is allowed for use in this research study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brain | Experimental | Procedure: Stereotactic Radiosurgery (SRS), Biological: IpilimumabA cohort of six (6) patients will be treated at Dosing Schedule 1. If the observed dose limiting toxicity (DLT) rate is less ≤33%, the dose cohort will be expended to a total of 15 patients. Brain and spine metastases will be evaluated as two separate cohorts. If the first schedule produces DLTs in >33% of patients, the Second Dosing schedule will be implemented. If the second dosing schedule produces DLTs in >33% of patients, the Third Dosing schedule will be implemented. After 6 patients were enrolled in a cohort, their safety and toxicity will be continuously monitored till 12 weeks (3 months) after the initial dose of Ipilimumab is given for evaluating dose-limiting toxicities. |
| Spine | Experimental | Procedure: Stereotactic Radiosurgery (SRS), Biological: IpilimumabA cohort of six (6) patients will be treated at Dosing Schedule 1. If the observed dose limiting toxicity (DLT) rate is less ≤33%, the dose cohort will be expended to a total of 15 patients. Brain and spine metastases will be evaluated as two separate cohorts. If the first schedule produces DLTs in >33% of patients, the Second Dosing schedule will be implemented. If the second dosing schedule produces DLTs in >33% of patients, the Third Dosing schedule will be implemented. After 6 patients were enrolled in a cohort, their safety and toxicity will be continuously monitored till 12 weeks (3 months) after the initial dose of Ipilimumab is given for evaluating dose-limiting toxicities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must have histologically confirmed diagnosis of melanoma. The pathologic confirmation may be from another metastatic site or from metastatic brain or spine lesions.
- Patients must have Stage IV melanoma, with newly identified brain or spine metastases.
- Patients must have measurable lesion in the brain or spine that is > 3 mm seen on magnetic resonance imaging (MRI) with contrast.
- NOTE: Contrasted pre-treatment MRI scan must be obtained ≤ 21 days prior to stereotactic radiosurgery treatment.
- Karnofsky Performance Scale >70%
Key exclusion criteria (14 listed)
- Prior whole brain radiation or conventional radiation to the spine at the site of new lesion.
- Prior chemotherapy within 28 days of starting treatment.
- Prior therapy with investigational drugs within 28 days or at least 5 half-lives (whichever is longer) before study administration.
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody.
- Neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
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 |
|---|---|---|
| Stereotactic Radiosurgery (SRS) | Procedure or surgery | Brain, Spine |
| Ipilimumab | Biological | Brain, Spine |
Primary outcome
Number of adverse events and severity of the adverse events.
Time frame: 2 years
To assess the safety profile of stereotactic radiosurgery with ipilimumab in combination to treat patients with newly diagnosed melanoma brain or spinal metastases.
1 secondary outcome
To estimate local control rate in brain and spine
Time frame: 1 years
Results and safety
The study was stopped early (reason given: Local IRB required us to submit amendment as a separate study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
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.
Michael Lim, MD principal investigator
Johns Hopkins Department of Neurosurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stereotactic Radiosurgery (SRS) and Ipilimumab in people with Newly Diagnosed Melanoma Metastases in the Brain and Spine, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 10 inclusion and 14 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: stopped early, as of the sponsor's last update on 15 Nov 2016. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 stopped early (reason given: Local IRB required us to submit amendment as a separate study.). Results are not available in the source record.
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?
Number of adverse events and severity of the adverse events. (time frame: 2 years). 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 15 Nov 2016.