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

NCT01748747 | Completed Early Phase 1 DMC

• 2 other identifiers: MC0972NCI-2012-01610
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Recurrent Melanoma; Stage IIA Melanoma; Stage IIB Melanoma; Stage IIC Melanoma; Stage IIIA Melanoma; Stage IIIB Melanoma; Stage IIIC Melanoma; Stage IV Melanoma

Outcome Measures

Primary Outcomes (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.

  Up to 12 months

Secondary Outcomes (2)

• Disease-free survival

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

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

  Up to 24 months

Study Arms (3)

Arm I (MART-1 antigen, Gag:267-274 peptide vaccine)

EXPERIMENTAL

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

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)

EXPERIMENTAL

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

Drug: Montanide ISA 51 VG; Biological: MART-1 antigen; Other: laboratory biomarker analysis

Arm III (MART-1 antigen, Gag:267-274 peptide, resiquimod)

EXPERIMENTAL

Patients 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.

Drug: Montanide ISA 51 VG; Biological: MART-1 antigen; Other: laboratory biomarker analysis; Biological: Gag:267-274 peptide vaccine; Drug: resiquimod

Interventions

Montanide ISA 51 VG DRUG

Given SC

Arm I (MART-1 antigen, Gag:267-274 peptide vaccine); Arm II (MART-1 antigen, resiquimod, Montanide ISA 51 VG); Arm III (MART-1 antigen, Gag:267-274 peptide, resiquimod)

MART-1 antigen BIOLOGICAL

Given SC

Also known as: Antigen LB39-AA, Antigen SK29-AA, MART-1, MART-1 Tumor Antigen

Arm I (MART-1 antigen, Gag:267-274 peptide vaccine); Arm II (MART-1 antigen, resiquimod, Montanide ISA 51 VG); Arm III (MART-1 antigen, Gag:267-274 peptide, resiquimod)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (MART-1 antigen, Gag:267-274 peptide vaccine); Arm II (MART-1 antigen, resiquimod, Montanide ISA 51 VG); Arm III (MART-1 antigen, Gag:267-274 peptide, resiquimod)

Gag:267-274 peptide vaccine BIOLOGICAL

Given SC

Also known as: ILGLNKIV

Arm I (MART-1 antigen, Gag:267-274 peptide vaccine); Arm III (MART-1 antigen, Gag:267-274 peptide, resiquimod)

resiquimod DRUG

Applied topically

Also known as: R 848, S 28463

Arm III (MART-1 antigen, Gag:267-274 peptide, resiquimod)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

montanide ISA 51; MART-1 Antigen; resiquimod; S 28463

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Melanoma-Specific Antigens; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens, Neoplasm; Antigens; Biological Factors

Study Officials

• Svetomir Markovic, M.D., Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2012
• First Posted: December 12, 2012
• Study Start: October 1, 2012
• Primary Completion: December 14, 2014
• Study Completion: March 30, 2017
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

US (1)