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Vaccine Therapy in Treating Patients With Transitional Cell Cancer of the Bladder Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Vaccine Therapy in Treating Patients With Transitional Cell Cancer of the Bladder conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Vaccine Therapy in Treating Patients With Transitional Cell Cancer of the Bladder Clinical research trials and Vaccine Therapy in Treating Patients With Transitional Cell Cancer of the Bladder medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Vaccine Therapy in Treating Patients With Transitional Cell Cancer of the Bladder. Vaccine Therapy in Treating Patients With Transitional Cell Cancer of the Bladder Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Vaccine Therapy in Treating Patients With Transitional Cell Cancer of the Bladder clinical trial. Participants frequently obtain the most expert healthcare available for their Vaccine Therapy in Treating Patients With Transitional Cell Cancer of the Bladder condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Transitional Cell Cancer of the Bladder  Vaccine Therapy in Treating Patients With Transitional Cell Cancer of the Bladder
Vaccine Therapy in Treating Patients With Transitional Cell Cancer of the Bladder
For Condition: transitional cell carcinoma of the bladder,stage 1 bladder cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Biological therapies, such as BCG and sargramostim, use different ways to stimulate the immune system and stop tumor cells from growing. Combining vaccine therapy with biological therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining vaccine therapy with BCG and sargramostim in treating patients who have undergone cystectomy for transitional cell cancer of the bladder.
Details: OBJECTIVES: - Determine the safety and tolerability of NY-ESO-1 peptide vaccine, BCG, and sargramostim (GM-CSF) in post-cystectomy patients with transitional cell carcinoma of the bladder expressing NY-ESO-1 or LAGE-1 antigen. - Determine the immunological profile (NY-ESO-1 antibody, CD8+ cells, and delayed-type hypersensitivity) induced by this regimen in these patients. OUTLINE: This is an open-label, pilot study. Patients receive NY-ESO-1 peptide vaccine mixed with BCG intradermally (ID) once weekly on weeks 1 and 2. Patients then receive NY-ESO-1 peptide mixed with sargramostim (GM-CSF) ID once weekly on day 2 of weeks 3-6. Patients also receive GM-CSF subcutaneously alone on days 1, 3, 4, and 5 of weeks 3-6. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed at 2 and 6 weeks. PROJECTED ACCRUAL: A total of 24-28 patients (8 HLA-A2 positive with prior intravesical BCG, 8 HLA-A2 positive without prior intravesical BCG, 4-6 HLA-A2 negative with prior intravesical BCG, and 4-6 HLA-A2 negative without prior intravesical BCG) will be accrued for this study within 15 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed transitional cell carcinoma of the bladder - Tumor expression of NY-ESO-1 by reverse transcription-polymerase chain reaction (RT-PCR) or immunohistochemistry OR LAGE-1 by RT-PCR - Prior cystectomy within the past 4-16 weeks - No evidence of disease by radiological imaging within the past month PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 3 months Hematopoietic - Neutrophil count at least 1,500/mm^3 - Lymphocyte count at least 500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10.0 g/dL - No bleeding disorders Hepatic - Bilirubin no greater than 2 mg/dL - AST and ALT less than 2.5 times upper limit of normal Renal - Creatinine no greater than 1.8 mg/dL Cardiovascular - No New York Heart Association class III or IV heart disease Immunologic - No history of immunodeficiency disease - No history of autoimmune disease Other - HIV negative - No prior severe reaction to PPD (at least 15 mm induration) - No other malignancy within the past 5 years that has been treated with extensive chemotherapy/radiotherapy, has the potential for immune dysfunction, or has evidence of metastasis at the time of study entry - No other serious illness - No serious infection requiring antibiotics - No mental disorder that would preclude the ability to give informed consent or comply with study requirements PRIOR CONCURRENT THERAPY: Biologic therapy - More than 4 weeks since prior immunotherapy - No prior bone marrow or peripheral blood stem cell transplantation Chemotherapy - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) - No concurrent chemotherapy Endocrine therapy - More than 30 days since prior corticosteroids - No concurrent systemic corticosteroids - Concurrent topical or inhalational steroids allowed Radiotherapy - More than 4 weeks since prior radiotherapy Surgery - See Disease Characteristics Other - At least 5 days since prior antibiotics - More than 4 weeks since prior participation in another clinical study - No concurrent antihistaminic drugs - No concurrent nonsteroidal anti-inflammatory drugs except low doses for prevention of an acute cardiovascular event or pain control - No concurrent immunosuppressive agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DeanBajorin, Principal Investigator, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Dean Bajorin 646-422-4333
Additional Information:
Study ID Numbers: CDR0000329920; LUDWIG-LUD2002-004,MSKCC-03047
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070070
Other Transitional Cell Carcinoma Of The Bladder Studies:
1. Eflornithine in Treating Patients With Bladder Cancer
2. Tipifarnib in Treating Patients With Recurrent Bladder Cancer
3. Paclitaxel in Treating Patients With Early-Stage Bladder Cancer
4. Combination Chemotherapy in Treating Patients With Bladder Cancer
5. Chemotherapy in Treating Patients With Early-Stage Bladder Cancer
Related Studies:
Other transitional cell carcinoma of the bladder Clinical Trials
Other New York Clinical Trials
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Vaccine Therapy in Treating Patients With Transitional Cell Cancer of the Bladder
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