MelanomaPhase 1NCT01672450
A Study of Intratumoral Injection of Interleukin-2 and Ipilimumab in Patients With Unresectable Stages III-IV Melanoma
A Phase 1 study testing Intratumoral Ipilimumab and Interleukin-2 in people with Melanoma, run by University of Utah at 1 site in United States.
Trial summary
This is a single center, open phase I dose escalation study. This study will assess the highest tolerable intratumoral dose of ipilimumab (Yervoy) in combination with IL-2 (Proleukin) in patients with unresectable stages III-IV melanoma with accessible cutaneous, subcutaneous, and/or nodal lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Intratumoral Ipilimumab and Interleukin-2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Aug 2014
- 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
- Histological diagnosis of melanoma, unresectable stages III-IV with accessible cutaneous, subcutaneous, and/or nodal lesions , according to the AJCC Staging Manual, 7th Edition, 2011.
- Note: Patients who are considered to have resectable disease but decline resection are eligible.
- At least one lesion > 0.5 cm and < 2 cm
- ECOG performance status 0, 1 or 2
- Negative pregnancy test for women of childbearing potential within 7 days of enrollment on study.
- WBC > 2,000/mm3; ANC > 1,000/mm3; platelet > 100,000/mm3;hemoglobin > 9 gm/dL (may be transfused)
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- Serum bilirubin levels <1.5 mg/dL except for patients with Gilbert's syndrome.
- Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) < 2.5 X upper limit of normal, alkaline phosphatase < 2.5 X upper limit of normal.
- Serum creatinine levels <1.5 mg/dL
- Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with ipilimumab or interleukin-2. Patients should agree to use an appropriate method of birth control while on study. Examples of adequate forms of birth control for women include oral or implanted contraceptives, intrauterine device (IUD), diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner and also based on the judgment of the investigator.
- Age > 18 years and of any gender or race.
- Able to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelines.
Who cannot join
- Concurrent therapy with any other non-protocol anti-cancer therapy
- Prior local therapy within 2 weeks or prior systemic therapy within 4 weeks of starting protocol treatment
- History of any other malignancy requiring active treatment
- Pre-existing autoimmunity: History of inflammatory bowel disease; history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome). History of vitiligo is allowed.
- Chronic use immunosuppressants or systemic corticosteroids. Note: Chronic use is defined as requiring corticosteroids for greater than one month prior to enrollment on study. Corticosteroid use for less than 1 month prior to enrollment is allowed, but use must stop prior to starting study treatment.
- Clinically significant cardiovascular disease (e.g., uncontrolled hypertension [BP >150/100], myocardial infarction or stroke within 6 months, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
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- Currently active systemic infection
- Known history of HIV infection or chronic hepatitis B or C.
- The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of the drugs in this protocol or place the subject at undue risk for treatment complications
- Pregnancy or breast feeding
- A history of a severe hypersensitivity reaction to ipilimumab or interleukin-2
- Any reason why, in the opinion of the investigator, the patient should not participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Official title: A Phase I Study of Intratumoral Injection of Interleukin-2 and Ipilimumab in Patients With Unresectable Stages III-IV Melanoma
This is a single center, open phase I dose escalation study. This study will assess the highest tolerable intratumoral dose of ipilimumab (Yervoy) in combination with IL-2 (Proleukin) in patients with unresectable stages III-IV melanoma with accessible cutaneous, subcutaneous, and/or nodal lesions. The objective is to primarily assess the safety of the drug combination, and to secondarily obtain preliminary data on the clinical efficacy of the combination.
- Conditions
- Melanoma
- Being tested
- Intratumoral Ipilimumab and Interleukin-2
- Keywords
- Histologically or cytologically proven melanoma; Stages III-IV; accessible cutaneous, subcutaneous, and/or nodal lesions; ECOG performance status 0 to 2
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intratumoral Ipilimumab and Interleukin-2Drug
Only 1 lesion, 0.5 -2 cm, will be treated. Interleukin-2, 3 mIU IT TIW x 2 weeks (days 1, 3 and 5), then BIW x 6 weeks (days 1 and 4). Escalating doses of Ipilimumab (0.1, 0.25, 0.5, 1, 2, mg) IT weekly x 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | All participants in this study will receive the same treatment. Receives: Drug: Intratumoral Ipilimumab and Interleukin-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events per patient
To assess safety of interleukin-2 and Ipilimumab combination and to select the recommended dose regimen for future phase II studies
Measured: 24 months
Secondary outcomes (2)
Starting and Ending measurements of treated lesions
Clinical response rate of treated lesions
Measured: 24 months
Starting and ending measurement of untreated lesions
Clinical response rate of untreated lesions
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionAug 2014
- Study completionAug 2014
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.
- More trials run by University of UtahThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hung Khong, MD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672450
- Sponsor's protocol ID
- HCI56809
- Status last verified
- Jul 2015
- First submitted
- 21 Aug 2012
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Intratumoral Injection of Interleukin-2 and Ipilimumab in Patients With Unresectable Stages III-IV Melanoma
- ClinicalTrials.gov ID
- NCT01672450
- Acronym / sponsor ID
- HCI56809
- Conditions
- Melanoma
- Keywords
- Histologically or cytologically proven melanoma; Stages III-IV; accessible cutaneous, subcutaneous, and/or nodal lesions; ECOG performance status 0 to 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 24 Aug 2012 (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 is a single center, open phase I dose escalation study. This study will assess the highest tolerable intratumoral dose of ipilimumab (Yervoy) in combination with IL-2 (Proleukin) in patients with unresectable stages III-IV melanoma with accessible cutaneous, subcutaneous, and/or nodal lesions. The objective is to primarily assess the safety of the drug combination, and to secondarily obtain preliminary data on the clinical efficacy of the combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Drug: Intratumoral Ipilimumab and Interleukin-2All participants in this study will receive the same treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histological diagnosis of melanoma, unresectable stages III-IV with accessible cutaneous, subcutaneous, and/or nodal lesions , according to the AJCC Staging Manual, 7th Edition, 2011.
- Note: Patients who are considered to have resectable disease but decline resection are eligible.
- At least one lesion > 0.5 cm and < 2 cm
- ECOG performance status 0, 1 or 2
- Negative pregnancy test for women of childbearing potential within 7 days of enrollment on study.
Key exclusion criteria (12 listed)
- Concurrent therapy with any other non-protocol anti-cancer therapy
- Prior local therapy within 2 weeks or prior systemic therapy within 4 weeks of starting protocol treatment
- History of any other malignancy requiring active treatment
- Pre-existing autoimmunity: History of inflammatory bowel disease; history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome). History of vitiligo is allowed.
- Chronic use immunosuppressants or systemic corticosteroids. Note: Chronic use is defined as requiring corticosteroids for greater than one month prior to enrollment on study. Corticosteroid use for less than 1 month prior to enrollment is allowed, but use must stop prior to starting study treatment.
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 |
|---|---|---|
| Intratumoral Ipilimumab and Interleukin-2Only 1 lesion, 0.5 -2 cm, will be treated. Interleukin-2, 3 mIU IT TIW x 2 weeks (days 1, 3 and 5), then BIW x 6 weeks (days 1 and 4). Escalating doses of Ipilimumab (0.1, 0.25, 0.5, 1, 2, mg) IT weekly x 8 weeks | Drug | All patients |
Primary outcome
Number of Adverse Events per patient
Time frame: 24 months
To assess safety of interleukin-2 and Ipilimumab combination and to select the recommended dose regimen for future phase II studies
2 secondary outcomes
Starting and Ending measurements of treated lesions
Time frame: 24 months
Starting and ending measurement of untreated lesions
Time frame: 24 months
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 8 Jul 2015.
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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.
Hung Khong, MD principal investigator
Huntsman Cancer Institute
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 Intratumoral Ipilimumab and Interleukin-2 in people with Melanoma, run by University of Utah 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 12 inclusion and 12 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 8 Jul 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 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 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?
Number of Adverse Events per patient (time frame: 24 months). 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 8 Jul 2015.