Radiofrequency Therapy-Induced Endogenous Heat-Shock Proteins With or Without Radiofrequency Ablation or Cryotherapy in Treating Patients With Stage IV Melanoma

NCT00568763 | Completed Phase 1 DMC

• 5 other identifiers: CDR0000579004P30CA015083MC04741189-05NCI-2009-01304
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; recurrent melanoma

Outcome Measures

Primary Outcomes (5)

• Toxicity

• Heat-shock protein levels

• Tumor-specific immune response

• Extent of lymphocyte infiltration

• Tumor response by RECIST criteria

Interventions

sargramostim BIOLOGICAL

immunoenzyme technique OTHER

immunohistochemistry staining method OTHER

immunologic technique OTHER

laboratory biomarker analysis OTHER

biopsy PROCEDURE

cryosurgery PROCEDURE

radiofrequency ablation PROCEDURE

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed malignant melanoma meeting the following criteria: * Stage IV disease * Needle/probe accessible lesions of metastatic melanoma evident in the liver (or soft tissue) measuring 2 to 5 cm in size * HLA-A2 positive * No known standard therapy that is potentially curative or proven capable of extending life expectancy PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 12 weeks * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 10.0 g/dL * Alkaline phosphatase ≤ 3 times upper limit of normal (ULN) * AST ≤ 3 times ULN * Creatinine ≤ 1.5 times ULN * Prothrombin time ≤ ULN * Activated partial thromboplastin time ≤ ULN * No uncontrolled or current infection * No symptomatic heart disease (i.e., New York Heart Association classification III or IV) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known immune deficiency PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 4 weeks since prior chemotherapy and recovered * More than 4 weeks since prior immunotherapy, biologic therapy, or radiotherapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

Study Sites (1)

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Domingo-Musibay E, Heun JM, Nevala WK, Callstrom M, Atwell T, Galanis E, Erickson LA, Markovic SN. Endogenous Heat-Shock Protein Induction with or Without Radiofrequency Ablation or Cryoablation in Patients with Stage IV Melanoma. Oncologist. 2017 Sep;22(9):1026-e93. doi: 10.1634/theoncologist.2017-0060. Epub 2017 Jul 5.

  PMID: 28679643 DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

sargramostim; Immunoenzyme Techniques; Immunohistochemistry; Immunologic Techniques; Biopsy; Cryosurgery; Radiofrequency Ablation

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)

Immunoassay; Investigative Techniques; Molecular Probe Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Ablation Techniques; Radiofrequency Therapy; Therapeutics

Study Officials

• Svetomir N Markovic, MD, PhD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2007
• First Posted: December 6, 2007
• Study Start: November 25, 2005
• Primary Completion: May 10, 2010
• Study Completion: May 24, 2018
• Last Updated: October 31, 2018

Record last verified: 2018-10

Locations

US (1)