Track topics on Twitter Track topics that are important to you
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
- Determine the overall response rates in patients with stage IV clear cell renal cell carcinoma treated with vaccine comprising HLA-A2- and HLA-A3-binding peptides from fibroblast growth factor-5 emulsified in Montanide ISA-51. (Cohorts A and B)
- Determine the effect of this vaccine on the response rate to high-dose interleukin-2 in these patients. (Cohorts A and B)
- Determine the immunologic response in patients with stage III clear cell renal cell carcinoma at high risk for relapse treated with this vaccine. (Cohort C)
- Determine the toxicity of this vaccine in these patients.
- Determine the immunologic response in patients with stage IV disease treated with this vaccine. (Cohorts A and B)
OUTLINE: Patients are stratified according to class I haplotype (HLA-A2 vs HLA-A3). Patients are assigned to 1 of 3 cohorts.
- Cohort A (no requirement for immediate interleukin-2 [IL-2] therapy): Patients receive vaccination comprising the HLA-appropriate binding peptide from fibroblast growth factor-5 (FGF-5) emulsified in Montanide ISA-51 subcutaneously (SC) once daily on days 1-4. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
At the time of disease progression, patients eligible for IL-2 who have not yet received it have high-dose IL-2 added to their regimen. Patients continue to receive peptide vaccination on days 1-4 and receive high-dose IL-2 IV over 15 minutes every 8 hours on days 2-5 (12 doses). Treatment repeats every 15-19 days for up to 1 year of total treatment.
- Cohort B (requirement for immediate IL-2 therapy): Patients receive vaccination comprising the HLA-appropriate binding peptide from FGF-5 emulsified in Montanide ISA-51 SC once daily on days 1-4. Patients also receive high-dose IL-2 IV over 15 minutes every 8 hours on days 2-5 (12 doses). Treatment repeats every 15-19 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
- Cohort C: Patients receive peptide vaccination as in cohort A. At the time of relapse, patients have high-dose IL-2 added to their regimen as in cohort A. Treatment repeats every 15-19 days for up to 6 months of total treatment.
Patients are followed every 3-6 months (cohorts A and B) OR every 3 months for 1 year and then every 6-12 months thereafter (cohort C).
PROJECTED ACCRUAL: A total of 36-210 patients (12-80 in cohort A, 12-66 in cohort B, and 12-64 in cohort C) will be accrued for this study within 5 years.
Masking: Open Label, Primary Purpose: Treatment
HLA-A2, A3-restricted FGF-5 peptides/Montanide ISA-51 vaccine, aldesleukin, adjuvant therapy
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:54:04-0400
The purposes of this study are to describe the immune response to individual peptides after immunization with a combination of 8 peptides and Montanide ISA-51; to determine the safety of t...
This was a phase I double blind controlled vaccine trial, evaluating safety, tolerability and immunogenicity of mixtures of N, R and C LSP derived from the P. vivax CS protein formulated i...
In this study, a melanoma vaccine (5 melanoma peptides) is given with either Montanide or dendritic cells as adjuvants. This randomized trial will establish the safety of both vaccines and...
The purpose of this study is to evaluate the safety and time to progression of HLA-A*2402 restricted epitope peptides URLC10, TTK, and KOC1, emulsified with Montanide ISA 51.
RATIONALE: Vaccines made from peptides that are found on leukemia cells may make the body build an immune response and kill cancer cells. Combining vaccine therapy with the immune adjuvant...
This study was conducted to evaluate an adjuvant, Montanide (IMS 3015), in improving the quality of Rift Valley fever (RVF) vaccine relative to the traditional adjuvant, aluminum hydroxide gel. Vaccin...
Vaccination with MHC-II-restricted peptides from Apolipoprotein B (ApoB) with complete and incomplete Freund's adjuvant (CFA/IFA) is known to protect mice from atherosclerosis. This vaccination induce...
There has been a rapid increase in adjuvant therapies approved for treatment following surgical resection of stages III/IV melanoma. We review current indications for adjuvant therapy, which currently...
In the present study, protective efficacy conferred by a cocktail protein consisted of Brucella L7/L12 ribosomal, truncated outer membrane protein 31 (TOmp31) and SOmp2b recombinant proteins in CpG OD...
Adjuvant effect of G2 (extraction of buffalo spleen) was assessed in intraperitoneally immunized rainbow trout (100-150 g) with killed- Y. ruckeri bacterin biotype I [0.1 mL (1 × 10 cells/f...
Drug therapy given to augment or stimulate some other form of treatment such as surgery or radiation therapy. Adjuvant chemotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.
A live vaccine containing attenuated poliovirus, types I, II, and III, grown in monkey kidney cell tissue culture, used for routine immunization of children against polio. This vaccine induces long-lasting intestinal and humoral immunity. Killed vaccine induces only humoral immunity. Oral poliovirus vaccine should not be administered to immunocompromised individuals or their household contacts. (Dorland, 28th ed)
Radiotherapy given to augment some other form of treatment such as surgery or chemotherapy. Adjuvant radiotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.
A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.
A bacterial vaccine for the prevention of brucellosis in man and animal. Brucella abortus vaccine is used for the immunization of cattle, sheep, and goats.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
A vaccine is any preparation intended to produce immunity to a disease by stimulating the production of antibodies. It creates immunity but does not cause the disease. There are several differnt types of vaccine avalable; Killed microorganisms; which s...
Chronic kidney disease (CKD), also known as chronic renal disease, is a progressive loss in renal function over a period of months or years. The symptoms of worsening kidney function are non-specific, and might include feeling generally unwell and experi...