Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
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|ClinicalTrials.gov Identifier: NCT00005841|
Recruitment Status : Terminated (Toxicity/Side Effects)
First Posted : May 26, 2004
Last Update Posted : May 22, 2014
RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to kill tumor cells. Vaccine therapy plus filgrastim combined with a specific protein may be a more effective treatment for melanoma.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with stage III or stage IV melanoma that has been completely removed during surgery.
|Condition or disease||Intervention/treatment||Phase|
|Intraocular Melanoma Melanoma (Skin)||Biological: MART-1 antigen Biological: gp100 antigen Biological: incomplete Freund's adjuvant Biological: progenipoietin Biological: tyrosinase peptide||Phase 1|
OBJECTIVES: I. Determine the maximum tolerated dose of filgrastim (G-CSF)-fetal liver tyrosine kinase-3 (Flt3K) fusion protein when combined with melanoma peptide vaccine comprising tyrosinase:368-376 peptide, gp100:209-217 antigen, and MART-1:26-35 antigen emulsified in Montanide ISA-51 in patients with completely resected stage III or IV melanoma. II. Determine the toxicity and safety of this regimen in these patients. III. Determine the immune responses to tyrosinase, MART-1, and gp100 antigens in patients before, during, and after receiving these vaccinations.
OUTLINE: This is a dose escalation, multicenter study of filgrastim (G-CSF)-fetal liver tyrosine kinase-3 (Flt3K) (G-CSF-Flt3K) fusion protein. Patients receive melanoma peptide vaccine comprising tyrosinase:368-376 peptide, gp100:209-217 antigen, and MART-1:26-35 antigen emulsified in Montanide ISA-51 subcutaneously (SQ) monthly for 6 months, and then at 9 and 12 months for a total of 8 vaccinations. Patients receive G-CSF-Flt3K fusion protein SQ daily for 3 days before, immediately after, and then daily for 6 days after each vaccination. Cohorts of 6-10 patients receive escalating doses of G-CSF-Flt3K fusion protein until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6-10 patients experience dose limiting toxicity. Patients are followed every 3 months through year 2 after resection, every 6 months for 3 years, and then annually thereafter until disease progression.
PROJECTED ACCRUAL: A total of 30-50 patients will be accrued for this study within 12-18 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Official Title:||A Phase I Trial of a Vaccine Combining Tyrosinase/GP100/Mart-1 Peptides Emulsified With Montanide ISA 51 With ProGP for Patients With Resected Stages III and IV Melanoma|
|Study Start Date :||June 2000|
|Actual Primary Completion Date :||December 2000|
|Actual Study Completion Date :||October 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005841
|United States, California|
|USC/Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033-0800|
|City of Hope National Medical Center|
|Los Angeles, California, United States, 91010|
|Study Chair:||Jeffrey S. Weber, MD, PhD||University of Southern California|