Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00470015 |
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Aldesleukin may stimulate the white blood cells to kill tumor cells. Giving vaccine and different doses of GM-CSF mixed in incomplete Freund's adjuvant, with or without aldesleukin, may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and how well giving vaccine therapy together with GM-CSF, with or without low-dose aldesleukin, works in treating patients with stage II, stage III, or stage IV melanoma.
Condition | Intervention |
---|---|
Melanoma (Skin) |
Drug: MART-1 antigen Drug: aldesleukin Drug: gp100 antigen Drug: incomplete Freund's adjuvant Drug: sargramostim Drug: survivin antigen |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Melanoma Peptide Vaccines (MART1 Analog, gp100 and Survivin) With GM-CSF and Low-Dose IL-2 as Immune Adjuvants, A Pilot Study |
Estimated Enrollment: | 20 |
Study Start Date: | February 2007 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a pilot study. Patients are stratified according to disease stage (II vs III or IV). Patients are sequentially enrolled into 1 of 4 different dose schedules.
Cohorts of 5 patients receive treatment at subsequent dose schedule until the maximum tolerated dose schedule (MTDS) is determined. The MTDS is defined as the dose schedule preceding that at which 2 of 5 patients experience dose-limiting toxicity within the first course.
After completion of study therapy, patients are followed every 3 months for up to 2 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed melanoma
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 |
Study Chair: | Svetomir Markovic, MD, PhD | Mayo Clinic |
Investigator: | Mark R. Pittelkow, MD | Mayo Clinic |
Investigator: | Ravi D. Rao, MD, MBBS | Mayo Clinic |
Investigator: | Edward T. Creagan, MD | Mayo Clinic |
Investigator: | Judith S. Kaur, MD | Mayo Clinic |
Investigator: | Lori A. Erickson, MD | Mayo Clinic |
Investigator: | Henry C. Pitot, MD | Mayo Clinic |
Study ID Numbers: | CDR0000542631, MAYO-MC0575 |
Study First Received: | May 3, 2007 |
Last Updated: | January 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00470015 |
Health Authority: | United States: Federal Government |
stage II melanoma stage III melanoma stage IV melanoma recurrent melanoma |
Neuroectodermal Tumors Aldesleukin Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Freund's Adjuvant Nevus Recurrence Neuroendocrine Tumors Melanoma |
Anti-Infective Agents Neoplasms by Histologic Type Anti-HIV Agents Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs |
Adjuvants, Immunologic Antiviral Agents Pharmacologic Actions Neoplasms Anti-Retroviral Agents Therapeutic Uses Nevi and Melanomas |