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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00568763 |
RATIONALE: Radiofrequency therapy and radiofrequency ablation use a high-frequency electric current to kill tumor cells. Radiofrequency therapy can also cause the body to produce heat-shock proteins which may help kill more tumor cells. Cryotherapy kills tumor cells by freezing them. It is not yet known whether heat-shock proteins caused by radiofrequency therapy given together with radiofrequency ablation or cryotherapy is more effective in treating stage IV melanoma than radiofrequency therapy-induced heat-shock proteins alone.
PURPOSE: This randomized clinical trial is studying the side effects of radiofrequency therapy-induced endogenous heat-shock proteins when given alone or together with radiofrequency ablation or cryotherapy in treating patients with stage IV melanoma.
Condition | Intervention |
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Melanoma (Skin) |
Drug: sargramostim Procedure: biopsy Procedure: cryosurgery Procedure: immunoenzyme technique Procedure: immunohistochemistry staining method Procedure: immunologic technique Procedure: laboratory biomarker analysis Procedure: radiofrequency ablation |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Endogenous Heat-Shock Vaccines for Melanoma A Feasibility Study |
Estimated Enrollment: | 14 |
Study Start Date: | November 2005 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients are randomized to 1 of 3 arms.
Tumor tissue samples are obtained by core biopsy immediately before and immediately after RFT for RNA and protein analysis. Tissue samples are assessed by immunohistochemistry for tumor phenotype (i.e., MART-1, tyrosinase, or gp100) and for quantification of infiltrating lymphocytes. Peripheral blood samples are also obtained before and after treatment and periodically during study for immunologic analyses. Peripheral blood-derived lymphocytes are tested with a panel of monoclonal antibodies to estimate the percentages of cytotoxic T lymphocytes (CTLs), including CD4+ and CD8+ T cells as well as B cells, monocytes, and dendritic cells. In addition, assays are performed to estimate T-cell responses to polyclonal stimulus (i.e., PHA), recall antigens (i.e., tetanus toxoid), and HLA alloantigens. Estimates of peptide-specific CTLs are also obtained by enzyme-linked immunosorbent spot assays after in vitro stimulation with peptide-sensitized stimulator cells. Hsp70 is assessed in tumor cells and peripheral blood by flow cytometry or enzyme-linked immunosorbent assays.
After completion of study therapy, patients are followed periodically for up to 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignant melanoma meeting the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Minnesota | |
Mayo Clinic Cancer Center | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 |
Study Chair: | Svetomir Markovic, MD, PhD | Mayo Clinic |
Investigator: | Matthew R. Callstrom, MD, PhD | Mayo Clinic |
Investigator: | J. William Charboneau, MD | Mayo Clinic |
Investigator: | Evanthia Galanis, MD | Mayo Clinic |
Investigator: | Lori A. Erickson, MD | Mayo Clinic |
Investigator: | Michael A. Farrell | Mayo Clinic |
Investigator: | Thomas D. Atwell, MD | Mayo Clinic |
Study ID Numbers: | CDR0000579004, MAYO-MC0474 |
Study First Received: | December 5, 2007 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00568763 |
Health Authority: | Unspecified |
stage IV melanoma recurrent melanoma |
Neuroectodermal Tumors Shock Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Recurrence Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |