Peptide Vaccine With Resiquimod as an Immune Modulator for Patients With Resected Melanoma: A Pilot Study
18 Years
N/A
Both
Recurrent Melanoma, Stage IIA Melanoma, Stage IIB Melanoma, Stage IIC Melanoma, Stage IIIA Melanoma, Stage IIIB Melanoma, Stage IIIC Melanoma, Stage IV Melanoma
Trial Information
Peptide Vaccine With Resiquimod as an Immune Modulator for Patients With Resected Melanoma: A Pilot Study
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Outcome Description:
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.
Outcome Time Frame:
Up to 12 months
Safety Issue:
No
Principal Investigator
Svetomir Markovic, M.D., Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Food and Drug Administration
Study ID:
MC0972
NCT ID:
NCT01748747
Start Date:
October 2012
Completion Date:
Related Keywords:
- Recurrent Melanoma
- Stage IIA Melanoma
- Stage IIB Melanoma
- Stage IIC Melanoma
- Stage IIIA Melanoma
- Stage IIIB Melanoma
- Stage IIIC Melanoma
- Stage IV Melanoma
- Melanoma
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
