Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Bethesda, Maryland 20892


Purpose:

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage III or stage IV kidney cancer.


Study summary:

OBJECTIVES: Primary - 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. Secondary - 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.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed clear cell renal cell carcinoma meeting one of the following criteria: - Measurable metastatic disease (cohorts A and B) - Tumor site must be safely accessible for biopsy OR have indications for resection of a tumor site (e.g., indicated nephrectomy or symptomatic metastasis) - Stage III primary tumor (i.e., T3 or T4 OR N1 or N2) removed within the past 6 months AND at high-risk for recurrence (cohort C) - Detectable fibroblast growth factor-5 tumor expression by reverse transcription polymerase chain reaction - Patients must be HLA-A2- or HLA-A3-positive PATIENT CHARACTERISTICS: Age - 16 and over Performance status - ECOG 0-1 Life expectancy - More than 3 months Hematopoietic - WBC ≥ 3,000/mm^3 - Platelet count ≥ 90,000/mm^3 - No coagulation disorders Hepatic - AST and ALT < 3 times normal - Bilirubin ≤ 1.6 mg/dL (< 3.0 mg/dL for patients with Gilbert's disease) - Hepatitis B surface antigen negative - Hepatitis C antibody negative (unless antigen negative) Renal - Creatinine ≤ 2.0 mg/dL Cardiovascular - Cardiac stress test normal in patients with EKG abnormalities, symptoms of cardiac ischemia, arrhythmias, or > 50 years old* - No cardiac ischemia* - No myocardial infarction* - No cardiac arrhythmias* - No other major medical illness of the cardiovascular system NOTE: *Eligibility for IL-2 administration Pulmonary - FEV_1 > 60% of predicted for patients with prolonged history of cigarette smoking or symptoms of respiratory dysfunction* - No obstructive or restrictive pulmonary disease* - No other major medical illness of the respiratory system NOTE: *Eligibility for IL-2 administration Immunologic - HIV negative - No active systemic infections - No known immunodeficiency disease - Immune competence is defined as lymphocyte count > 500/mm^3, WBC ≥ 1,000/mm^3, and no opportunistic infections - No known allergic reaction to Montanide ISA-51 - No hypersensitivity to any agent used in this study Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 3 months after study participation - Willing or able to undergo biopsy - No other active major medical illness PRIOR CONCURRENT THERAPY: Biologic therapy - Prior low-dose interleukin-2 (IL-2) (less than 600,000 IU/kg) allowed Chemotherapy - More than 6 weeks since prior nitrosoureas Endocrine therapy - No concurrent systemic steroid therapy Radiotherapy - Local radiotherapy within the past 3 weeks allowed Surgery - See Disease Characteristics - Minor surgical procedures within the past 3 weeks allowed Other - Recovered from all prior therapy - More than 3 weeks since any other prior therapy for the malignancy - No other concurrent therapy for the malignancy


NCT ID:

NCT00091403


Primary Contact:

Principal Investigator
James C. Yang, MD
NCI - Surgery Branch


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.