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| Sponsor: | University of Medicine and Dentistry New Jersey |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | University of Medicine and Dentistry New Jersey |
| ClinicalTrials.gov Identifier: | NCT00072137 |
Purpose
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: This phase I trial is studying the side effects and best dose of intravesical vaccine therapy in treating patients who are undergoing cystectomy for bladder cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer |
Biological: recombinant fowlpox GM-CSF vaccine adjuvant Biological: recombinant fowlpox-TRICOM vaccine Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study of Intravesical Recombinant Fowlpox - GM-CSF (rF-GM-CSF) and/or Recombinant Fowlpox-Tricom (rF-TRICOM) in Patients With Muscle-Invasive Bladder Carcinoma |
| Enrollment: | 21 |
| Study Start Date: | October 2003 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
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 4-5 days 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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed cancer of the urinary bladder, including the following cellular types:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
No history of autoimmune disease, including, but not limited to, the following:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, New Jersey | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| Study Chair: | Edmund C. Lattime, PhD | Cancer Institute of New Jersey |
More Information
| Responsible Party: | Edmund Lattime, PhD, UMDNJ |
| ClinicalTrials.gov Identifier: | NCT00072137 History of Changes |
| Other Study ID Numbers: | CDR0000335473, R21CA074543, P30CA072720, CINJ-3909, NCI-5585 |
| Study First Received: | November 4, 2003 |
| Last Updated: | January 26, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
stage II bladder cancer squamous cell carcinoma of the bladder adenocarcinoma of the bladder recurrent bladder cancer |
transitional cell carcinoma of the bladder stage III bladder cancer stage 0 bladder cancer stage I bladder cancer |
|
Urinary Bladder Neoplasms Carcinoma Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Neoplasms Urinary Bladder Diseases Urologic Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |