MelanomaPhase 2NCT00515528
Vaccination Plus Ontak in Patients With Metastatic Melanoma
A Phase 2 study testing 4-peptide melanoma vaccine and Ontak in people with Melanoma, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to determine if an experimental melanoma vaccine can produce an immune response in patients with metastatic melanoma, and if combining this vaccine with the drug Ontak can improve these immune responses. It is also hoped that this will lead to tumor shrinkage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- 4-peptide melanoma vaccine and Ontak
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2007to Mar 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Melanoma with evidence of metastatic disease
- Life expectancy of at least 12 weeks.
- Karnofsky performance status index of greater than or equal to 80%.
- Adequate hematopoietic, renal, and hepatic function, defined as:
- Patient must express HLA-A2
- Tumor biopsy: patient must agree to undergo biopsy of accessible tumor before and after therapy, when feasible, to study tumor cell properties and characteristics of immune cells.
- EKG without evidence of arrhythmia or changes that indicate acute ischemia.
- Pulse oximetry showing oxygen saturation of at least 90% on room air.
Who cannot join
- Significant cardiovascular disease, or cardiac arrhythmia requiring medical intervention.
- Pregnant or nursing women.
- Biological therapy in the 4 weeks prior to the start of dosing.
- Patients with intrinsic immunosuppression, including seropositivity for HIV antibody.
- Serious concurrent infection, including active tuberculosis, hepatitis B, or hepatitis C.
- Concurrent systemic corticosteroids (except physiologic replacement doses)or other immunosuppressive drugs (eg. cyclosporin A).
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- Psychiatric illness that may make compliance to the clinical protocol unmanageable or may compromise the ability of the patient to give informed consent.
- Active or history of autoimmune disease
- Active gastrointestinal bleeding or uncontrolled peptic ulcer disease.
- Presence of untreated brain metastases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Phase II Study of Multipeptide Vaccination With or Without Regulatory T Cell Depletion Using Ontak in Patients With Metastatic Melanoma
The purpose of this study is to determine if an experimental melanoma vaccine can produce an immune response in patients with metastatic melanoma, and if combining this vaccine with the drug Ontak can improve these immune responses. It is also hoped that this will lead to tumor shrinkage.
Read the detailed description
This is an open-label, randomized phase II, single institution study comparing administration of a 4-peptide melanoma vaccine alone or post-Ontak, in patients with metastatic melanoma.
Treatment:
- Cohort A: Vaccine alone. Patients will receive immunization with an emulsion of 4 melanoma peptides (250 mcg each)/GM-CSF/Montanide injected intradermally/subcutaneously on day 1. A second vaccination will be given 2 weeks later and a third vaccination 2 weeks after that. Patients will be re-evaluated around week 6 and can continue courses of 3 vaccinations (one every 2 weeks) until disease progression.
- Cohort B: Ontak plus vaccine. Patients will receive Ontak (18 mcg/kg) intravenously on day -4 for one dose. On day 0, they will receive the first immunization with an emulsion of 4 melanoma peptides (250 mcg each)/GM-CSF/Montanide injected intradermally/subcutaneously. A second vaccination will be given 2 weeks later and a third vaccination 2 weeks after that. Patients will be re-evaluated around week 6 and can continue courses of 3 vaccinations (one every 2 weeks) until disease progression. However, no further Ontak will be given.
Duration: Patients may remain on study until disease progression, unacceptable toxicity, patient choice to withdraw, or physician decision to discontinue therapy (due to intervening illness, poor patient compliance, or other situation that would increase patient risk).
- Conditions
- Melanoma
- Being tested
- 4-peptide melanoma vaccine, Ontak
- Keywords
- metastatic melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-peptide melanoma vaccineBiological
Experimental cancer vaccine given as a shot under the skin once every two weeks
OntakDrug
A single dose of Ontak given as an intravenous infusion over 30 minutes, 4 days before the first vaccine is given.
| Study group | Role | What they receive |
|---|---|---|
| Vaccine Alone | Experimental | Subjects received vaccine immunization injected intra-dermally or subcutaneously on day 1. The vaccine was an emulsification consisting of 250 mcg each of the following peptides: Melan-A, gp100, MAGE-3, and NA17 as well as GM-CSF 125 mcg and Montanide. A second and third vaccination was given at 2 weeks and 4 weeks after the first. If there was no evidence of cancer progression, additional courses of three vaccinations administered at 2 week intervals were administered until disease progression. Receives: Biological: 4-peptide melanoma vaccine |
| Vaccine plus Ontak | Experimental | Subjects in Vaccine plus Ontak received the same vaccination strategy as Vaccine alone group but additionally received a single dose of denileukin diftitox(18 mcg/kg) 4 days prior to the first vaccine administration Receives: Biological: 4-peptide melanoma vaccine; Drug: Ontak |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response Outcome
Proportion of Patients With a Best Response of Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD).
Response was evaluated every 6 weeks based on Response Evaluation In Solid Tumor (RECIST) version 1.1.
Per RECIST v1.1 for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2007 (estimated)
- Study start23 Apr 2007
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: The immune monitoring data failed to demonstrate an improvement in any biologic endpoint with denileukin diftitox.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc.
- Responsible party
- Sponsor
- Investigators
- Thomas Gajeweski, MD, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515528
- Sponsor's protocol ID
- 15232B
- Status last verified
- Jan 2021
- First submitted
- 9 Aug 2007
- Last updated
- 26 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Luke JJ, Zha Y, Matijevich K, Gajewski TF. Single dose denileukin diftitox does not enhance vaccine-induced T cell responses or effectively deplete Tregs in advanced melanoma: immune monitoring and clinical results of a randomized phase II trial. J Immunother Cancer. 2016 Jun 21;4:35. doi: 10.1186/s40425-016-0140-2. eCollection 2016.
PubMed 27330808
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of Multipeptide Vaccination With or Without Regulatory T Cell Depletion Using Ontak in Patients With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00515528
- Acronym / sponsor ID
- 15232B
- Conditions
- Melanoma
- Keywords
- metastatic melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The immune monitoring data failed to demonstrate an improvement in any biologic endpoint with denileukin diftitox.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Eisai Inc.
- Study start
- 23 Apr 2007 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 13 Aug 2007 (estimated)
- Results
- Posted 29 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if an experimental melanoma vaccine can produce an immune response in patients with metastatic melanoma, and if combining this vaccine with the drug Ontak can improve these immune responses. It is also hoped that this will lead to tumor shrinkage.
Detailed description
This is an open-label, randomized phase II, single institution study comparing administration of a 4-peptide melanoma vaccine alone or post-Ontak, in patients with metastatic melanoma.
Treatment:
- Cohort A: Vaccine alone. Patients will receive immunization with an emulsion of 4 melanoma peptides (250 mcg each)/GM-CSF/Montanide injected intradermally/subcutaneously on day 1. A second vaccination will be given 2 weeks later and a third vaccination 2 weeks after that. Patients will be re-evaluated around week 6 and can continue courses of 3 vaccinations (one every 2 weeks) until disease progression.
- Cohort B: Ontak plus vaccine. Patients will receive Ontak (18 mcg/kg) intravenously on day -4 for one dose. On day 0, they will receive the first immunization with an emulsion of 4 melanoma peptides (250 mcg each)/GM-CSF/Montanide injected intradermally/subcutaneously. A second vaccination will be given 2 weeks later and a third vaccination 2 weeks after that. Patients will be re-evaluated around week 6 and can continue courses of 3 vaccinations (one every 2 weeks) until disease progression. However, no further Ontak will be given.
Duration: Patients may remain on study until disease progression, unacceptable toxicity, patient choice to withdraw, or physician decision to discontinue therapy (due to intervening illness, poor patient compliance, or other situation that would increase patient risk).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine Alone | Experimental | Biological: 4-peptide melanoma vaccineSubjects received vaccine immunization injected intra-dermally or subcutaneously on day 1. The vaccine was an emulsification consisting of 250 mcg each of the following peptides: Melan-A, gp100, MAGE-3, and NA17 as well as GM-CSF 125 mcg and Montanide. A second and third vaccination was given at 2 weeks and 4 weeks after the first. If there was no evidence of cancer progression, additional courses of three vaccinations administered at 2 week intervals were administered until disease progression. |
| Vaccine plus Ontak | Experimental | Biological: 4-peptide melanoma vaccine, Drug: OntakSubjects in Vaccine plus Ontak received the same vaccination strategy as Vaccine alone group but additionally received a single dose of denileukin diftitox(18 mcg/kg) 4 days prior to the first vaccine administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Melanoma with evidence of metastatic disease
- Life expectancy of at least 12 weeks.
- Karnofsky performance status index of greater than or equal to 80%.
- Adequate hematopoietic, renal, and hepatic function, defined as:
- Patient must express HLA-A2
Key exclusion criteria (10 listed)
- Significant cardiovascular disease, or cardiac arrhythmia requiring medical intervention.
- Pregnant or nursing women.
- Biological therapy in the 4 weeks prior to the start of dosing.
- Patients with intrinsic immunosuppression, including seropositivity for HIV antibody.
- Serious concurrent infection, including active tuberculosis, hepatitis B, or hepatitis C.
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 |
|---|---|---|
| 4-peptide melanoma vaccineExperimental cancer vaccine given as a shot under the skin once every two weeks | Biological | Vaccine Alone, Vaccine plus Ontak |
| OntakA single dose of Ontak given as an intravenous infusion over 30 minutes, 4 days before the first vaccine is given. | Drug | Vaccine plus Ontak |
Primary outcome
Clinical Response Outcome
Time frame: 6 weeks
Proportion of Patients With a Best Response of Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD). Response was evaluated every 6 weeks based on Response Evaluation In Solid Tumor (RECIST) version 1.1. Per RECIST v1.1 for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27330808Luke JJ, Zha Y, Matijevich K, Gajewski TF. Single dose denileukin diftitox does not enhance vaccine-induced T cell responses or effectively deplete Tregs in advanced melanoma: immune monitoring and clinical results of a randomized phase II trial. J Immunother Cancer. 2016 Jun 21;4:35. doi: 10.1186/s40425-016-0140-2. eCollection 2016.
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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.
Thomas Gajeweski, MD, PhD principal investigator
University of Chicago
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 4-peptide melanoma vaccine and Ontak in people with Melanoma, run by University of Chicago 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 8 inclusion and 10 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 26 Jan 2021. 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?
Yes. Results are posted in the registry (first posted 29 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Outcome (time frame: 6 weeks). 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 NCT00515528, which also lists 1 linked publication.
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 26 Jan 2021.