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Recurrent MelanomaEarly Phase 1NCT01748747

Vaccine Therapy and Resiquimod in Treating Patients With Stage II-IV Melanoma That Has Been Removed By Surgery

A Early Phase 1 study testing Montanide ISA 51 VG, MART-1 antigen and laboratory biomarker analysis in people with Recurrent Melanoma and Stage IIA Melanoma, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This pilot clinical trial studies vaccine therapy and resiquimod in treating patients with stage II-IV melanoma that has been removed by surgery. Vaccines made from peptides may help the body build an effective immune response to kill tumor cell tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Montanide ISA 51 VG, MART-1 antigen and laboratory biomarker analysis
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Oct 2012to 30 Mar 2017
Phase
Early 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

  • Central pathology review submission; this review for MART-1 positivity is mandatory prior to registration to confirm eligibility
  • Human leukocyte antigen (HLA)-A2-positive
  • Histologic proof of stage II, III or IV melanoma that has been completely resected with no current evidence of disease, as demonstrated by imaging within 2 months (stage III or stage IV; must be computed tomography [CT], magnetic resonance imaging [MRI], or positron emission tomography [PET]/CT) or 6 months (stage II; may be chest x-ray, CT, MRI, or PET/CT)
  • Absolute neutrophil count (ANC) >= 1500 mL
  • Hemoglobin (Hgb) > 10 g/dL
  • Platelets (PLT) >= 50,000 mL
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  • Aspartate aminotransferase (AST) =< 3 x upper limit of normal (ULN)
  • Alkaline phosphatase =< 3 x ULN
  • Ability to provide informed consent
  • Willingness to return to Mayo Clinic Rochester for follow-up
  • Life expectancy >= 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
  • For women of childbearing potential, a negative serum pregnancy test =< 7 days prior to registration
  • Willingness to provide mandatory blood samples for correlative research

Who cannot join

  • Uncontrolled or current infection
  • Known standard therapy for the patient's disease that is potentially curative or proven capable of extending life expectancy
  • Known allergy to vaccine or adjuvant components
  • Any of the following prior therapies with interval since most recent treatment:
  • Chemotherapy =< 4 weeks prior to registration
  • Biologic therapy or immunotherapy =< 4 weeks prior to registration
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  • Radiation therapy =< 4 weeks prior to registration
  • Failure to fully recover from side effects of prior chemotherapy or surgery
  • Any of the following, as this regimen may be harmful to a developing fetus or nursing child:
  • Pregnant women
  • Nursing women
  • Women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.)
  • Known immune deficiency, including human immunodeficiency virus (HIV) infection, as patients with known immune deficiencies will likely not be able to mount an immune response to the study vaccine; in addition, study patients should be naive to the HIV-derived Gag267-274 antigen
  • History of systemic autoimmune disease, as patients with ongoing autoimmunity may be at an increased risk of autoimmune toxicity from the study vaccine
  • Current or recent (=< 4 weeks prior to registration) use of immunosuppressive medications including systemic corticosteroids; (use of corticosteroids in doses not exceeding those used for adrenal replacement is acceptable)
  • History of brain metastases (even if completely resected)
  • Other active malignancy =< 5 years prior to registration; EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: If there is a history or prior malignancy, they must not be receiving other treatment for their cancer

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Peptide Vaccine With Resiquimod as an Immune Modulator for Patients With Resected Melanoma: A Pilot Study

This pilot clinical trial studies vaccine therapy and resiquimod in treating patients with stage II-IV melanoma that has been removed by surgery. Vaccines made from peptides may help the body build an effective immune response to kill tumor cell tumor cells. Biological therapies, such as resiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether Gag:267-274 peptide vaccine and resiquimod are more effective when given together or separately

Read the detailed description

PRIMARY OBJECTIVES:

  1. Evaluate the immune response of each immunization regimen and determine an optimal regimen in terms of immune response to recommend for phase II testing.

SECONDARY OBJECTIVES:

  1. Evaluate the adverse events profile of each immunization regimen. II. Evaluate disease-free survival.

TERTIARY OBJECTIVES:

  1. Describe the immunological efficacy of the vaccine preparations with Gag267-274 (Gag:267-274 peptide vaccine) and resiquimod, as measured by the frequency and interferon (IFN)gamma production of peptide-specific cytotoxic T lymphocytes (CTL).

II. Examine immune responses to the tumor antigen analog MART-1a (MART-1 antigen) versus the xenoantigen Gag267-274.

OUTLINE: Patients are assigned to 1 of 3 treatment groups.

ARM I: Patients receive MART-1 antigen and Gag:267-274 peptide vaccine emulsified in Montanide ISA 51 VG subcutaneously (SC) on day 1.

ARM II: Patients receive MART-1 antigen emulsified in Montanide ISA 51 VG SC followed by resiquimod applied topically on day 1.

ARM III: Patients receive MART-1 antigen and Gag:267-274 peptide vaccine emulsified in Montanide ISA 51 VG SC followed by resiquimod applied topically on day 1.

In all arms, treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 3, 6, 9, 12 and 24 months.

Being tested
Montanide ISA 51 VG, MART-1 antigen, laboratory biomarker analysis, Gag:267-274 peptide vaccine, resiquimod
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Montanide ISA 51 VGDrug

    Given SC

  • MART-1 antigenBiological

    Also called Antigen LB39-AA, Antigen SK29-AA, MART-1, MART-1 Tumor Antigen

    Given SC

  • laboratory biomarker analysisOther

    Correlative studies

  • Gag:267-274 peptide vaccineBiological

    Also called ILGLNKIV

    Given SC

  • resiquimodDrug

    Also called R 848, S 28463

    Applied topically

Study groups in NCT01748747
Study groupRoleWhat they receive
Arm I (MART-1 antigen, Gag:267-274 peptide vaccine)ExperimentalPatients receive MART-1 antigen and Gag:267-274 peptide vaccine emulsified in Montanide ISA 51 VG SC on day 1.
Receives: Drug: Montanide ISA 51 VG; Biological: MART-1 antigen; Other: laboratory biomarker analysis; Biological: Gag:267-274 peptide vaccine
Arm II (MART-1 antigen, resiquimod, Montanide ISA 51 VG)ExperimentalPatients receive MART-1 antigen emulsified in Montanide ISA 51 VG SC followed by resiquimod applied topically on day 1.
Receives: Drug: Montanide ISA 51 VG; Biological: MART-1 antigen; Other: laboratory biomarker analysis
Arm III (MART-1 antigen, Gag:267-274 peptide, resiquimod)ExperimentalPatients receive MART-1 antigen and Gag:267-274 peptide vaccine peptide vaccine emulsified in Montanide ISA 51 VG SC followed by resiquimod applied topically on day 1.
Receives: Drug: Montanide ISA 51 VG; Biological: MART-1 antigen; Other: laboratory biomarker analysis; Biological: Gag:267-274 peptide vaccine; Drug: resiquimod

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immune response of each vaccination regimen, defined as a 2-fold or more increase from pre-treatment levels in the frequency of vaccine peptide-specific CTL as measured by tetramer staining

    The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true immune response rate will be calculated.

    Measured: Up to 12 months

Secondary outcomes (2)

  1. Disease-free survival

    Estimated using the method of Kaplan-Meier.

    Measured: From registration to recurrence, new primary, or death due to any cause, assessed up to 24 months

  2. Incidence of adverse events, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

    The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2012 (estimated)
  2. Study startOct 2012
  3. Primary completion14 Dec 2014
  4. Study completion30 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01748747
Sponsor's protocol ID
MC0972
Other IDs
NCI-2012-01610
Status last verified
Oct 2018
First submitted
10 Dec 2012
Last updated
9 Oct 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Montanide ISA 51 VG, MART-1 antigen and laboratory biomarker analysis in people with Recurrent Melanoma and Stage IIA Melanoma, run by Mayo Clinic 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 14 inclusion and 17 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 9 Oct 2018. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Immune response of each vaccination regimen, defined as a 2-fold or more increase from pre-treatment levels in the frequency of vaccine peptide-specific CTL as measured by tetramer staining (time frame: Up to 12 months). 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 NCT01748747.

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 9 Oct 2018.

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