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Home > "N" Clinical Trials Conditions > Neoadjuvant Intravesical Vaccine Therapy in Treating Patients With Bladder Carcinoma Who Are Undergoing Cystectomy  Neoadjuvant Intravesical Vaccine Therapy in Treating Patients With Bladder Carcinoma Who Are Undergoing Cystectomy
Neoadjuvant Intravesical Vaccine Therapy in Treating Patients With Bladder Carcinoma Who Are Undergoing Cystectomy
For Condition: Bladder Cancer
Status: Recruiting
Sponsor(s): Cancer Institute of New Jersey , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Placing a vaccine directly into the bladder may cause a stronger immune response and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of neoadjuvantintravesical vaccine therapy in treating patients who are undergoing cystectomy for bladder carcinoma (cancer).
Details: OBJECTIVES: Primary - Determine the maximum tolerated dose of neoadjuvant intravesical recombinant fowlpox-TRICOM vaccine and/or recombinant fowlpox-sargramostim vaccine in patients with bladder carcinoma who are scheduled for cystectomy. - Determine the dose-limiting toxic effects of these regimens in these patients. Secondary - Determine the local and systemic immunologic response in patients treated with these regimens. OUTLINE: This is an open-label, dose-escalation study. Patients are alternately assigned to regimens A and B. Once regimens A and B have finished accrual, patients are assigned to regimen C. - Regimen A: Patients receive recombinant fowlpox-sargramostim vaccine intravesically on days 1, 8, 15, and 22 for a total of 4 doses. - Regimen B: Patients receive recombinant fowlpox-TRICOM vaccine intravesically on days 1, 8, 15, and 22 for a total of 4 doses. - Regimen C: Patients receive recombinant fowlpox-TRICOM vaccine combined with recombinant fowlpox-sargramostim vaccine intravesically on days 1, 8, 15, and 22 for a total of 4 doses. In all regimens, the vaccine(s) is delivered into the bladder by urinary catheter and retained for 2 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. In all regimens, patients undergo cystectomy within 48-96 hours after the last (4th) intravesical instillation. Cohorts of 3-6 patients in each regimen receive escalating doses of recombinant fowlpox-sargramostim vaccine and/or recombinant fowlpox-TRICOM vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 6 months for 2 years and then annually for 3 years. PROJECTED ACCRUAL: Approximately 24-42 patients will be accrued for this study within 12-18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed cancer of the urinary bladder, including the following cellular types: - Transitional cell carcinoma - Adenocarcinoma - Squamous cell carcinoma - Requires cystectomy as standard therapy and scheduled to undergo surgery - Ineligible for neoadjuvant chemotherapy PATIENT CHARACTERISTICS: Age - Not specified Performance status - ECOG 0-1 Life expectancy - At least 6 months Hematopoietic - Absolute neutrophil count greater than 1,500/mm^3 - Platelet count greater than 75,000/mm^3 Hepatic - SGOT less than 2 times normal - Bilirubin less than 2.0 mg/dL Renal - Creatinine less than 1.5 mg/dL OR - Creatinine clearance greater than 60 mL/min Cardiovascular - No active ischemic heart disease (i.e., New York Heart Association class III or IV cardiac disease) - No myocardial infarction within the past 6 months - No history of congestive heart failure - No history of ventricular arrhythmias or other arrhythmias requiring therapy Immunologic - No history of autoimmune disease, including, but not limited to, the following: - Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia - Systemic lupus erythematosus - Sjögren's syndrome - Scleroderma - Myasthenia gravis - Goodpasture's syndrome - Addison's disease - Hashimoto's thyroiditis - Active Graves' disease - No immunodeficiency disorder (e.g., AIDS, SCID, or Wiskott-Aldrich syndrome) - No other immunodeficiency disease Other - Not pregnant or nursing - Negative pregnancy test - All patients must abstain from sexual intercourse during and for at least 1 month after final treatment dose - No known allergy to eggs - No active uncontrolled infection - No other active malignancy within the past 5 years except superficial squamous cell or basal cell skin cancer or carcinoma in situ of the cervix or prostate - No other medical illness that would preclude study participation - No uncontrolled psychiatric illness that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - At least 4 weeks since prior immunotherapy - At least 2 months since prior intravesical BCG Chemotherapy - No prior neoadjuvant chemotherapy - At least 4 weeks since prior systemic chemotherapy - At least 2 months since prior intravesical chemotherapy Endocrine therapy - At least 4 weeks since prior systemic steroids - No concurrent or imminent steroid therapy Radiotherapy - No prior radiotherapy to the bladder - At least 4 weeks since prior radiotherapy Surgery - Not specified Other - Recovered from prior therapy - No concurrent active antibiotic therapy except as prophylaxis - No concurrent immunosuppressive therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MalgorzataWojtowicz, Study Chair, Cancer Institute of New Jersey
Cancer Institute of New Jersey *Recruiting*
New Brunswick, New Jersey, 08903
United States
Recruiting Cecilia Thomas 732-235-8780
Additional Information:
Study ID Numbers: CDR0000335473; NCI-5585,CINJ-3909
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00072137
Other Bladder Cancer Studies:
1. Bladder Cancer Case Control Study of Arsenic in Water
2. Neoadjuvant Carboplatin, Paclitaxel, and Gemcitabine Followed by Cisplatin and Radiation Therapy in Treating Patients With Locally Advanced or Recurrent Carcinoma of the Urothelium
3. Fluorouracil, Leucovorin, Gemcitabine, and Cisplatin in Treating Patients With Metastatic or Unresectable Adenocarcinoma of the Urothelium or Urachal Remnant
4. Nitrocamptothecin in Treating Patients With Metastatic Cancer of the Urinary Tract
5. Short-Term Low-Dose Interferon alfa in Treating Patients With Cancer of the Urothelium
Related Studies:
Other Bladder Cancer Clinical Trials
Other New Jersey Clinical Trials
Other New Brunswick Clinical Trials
Neoadjuvant Intravesical Vaccine Therapy in Treating Patients With Bladder Carcinoma Who Are Undergoing Cystectomy
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