Melanoma Clinical Trial

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

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. 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

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Full Description

PRIMARY OBJECTIVES:

I. 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:

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

TERTIARY OBJECTIVES:

I. 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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
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

Exclusion Criteria:

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
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

Study is for people with:

Melanoma

Phase:

Early Phase 1

Estimated Enrollment:

30

Study ID:

NCT01748747

Recruitment Status:

Completed

Sponsor:

Mayo Clinic

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There is 1 Location for this study

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Mayo Clinic
Rochester Minnesota, 55905, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Early Phase 1

Estimated Enrollment:

30

Study ID:

NCT01748747

Recruitment Status:

Completed

Sponsor:


Mayo Clinic

How clear is this clinincal trial information?

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