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Sponsors and Collaborators: |
University of Virginia National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00118313 |
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells.
Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Giving vaccine therapy together with imiquimod after surgery may help the body kill any remaining tumor cells.
PURPOSE: This randomized phase I trial is studying the side effects and best way to give vaccine therapy with or without imiquimod in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.
Condition | Intervention | Phase |
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Melanoma (Skin) |
Biological: incomplete Freund's adjuvant Biological: multi-epitope melanoma peptide vaccine Biological: sargramostim Biological: tetanus toxoid helper peptide Drug: dimethyl sulfoxide Drug: imiquimod Procedure: adjuvant therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Evaluation of Different Adjuvants for the Transdermal Administration of a Peptide-Based Vaccine in Participants With High-Risk Melanoma |
Study Start Date: | November 2004 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 4 treatment arms.
In all arms, treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 3 and 5 weeks and then at disease progression.
PROJECTED ACCRUAL: A maximum of 26 patients (approximately 6 per treatment arm) will be accrued for this study within approximately 2 years.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed melanoma
Has undergone surgical resection within the past 12 months
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
The following immunologic conditions are allowed:
Other
No uncontrolled diabetes
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Virginia | |
University of Virginia Cancer Center | |
Charlottesville, Virginia, United States, 22908 |
Principal Investigator: | Craig L. Slingluff, MD | University of Virginia |
Study ID Numbers: | CDR0000430925, UVACC-MEL-45, UVACC-HIC-11490, UVACC-34204 |
Study First Received: | July 8, 2005 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00118313 History of Changes |
Health Authority: | United States: Federal Government |
stage II melanoma stage III melanoma stage IV melanoma |
Antioxidants Immunologic Factors Interferons Adjuvants, Immunologic Imiquimod Melanoma Neuroendocrine Tumors |
Neuroectodermal Tumors Dimethyl Sulfoxide Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Freund's Adjuvant Nevus |
Interferon Inducers Antioxidants Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Adjuvants, Immunologic Imiquimod Protective Agents Cryoprotective Agents |
Pharmacologic Actions Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Dimethyl Sulfoxide Therapeutic Uses Neoplasms, Germ Cell and Embryonal Free Radical Scavengers Nevi and Melanomas Freund's Adjuvant |