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| Tracking Information | |||||
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| First Received Date ICMJE | November 4, 2003 | ||||
| Last Updated Date | February 4, 2009 | ||||
| Start Date ICMJE | October 2003 | ||||
| Estimated Primary Completion Date | July 2005 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00072137 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Neoadjuvant Intravesical Vaccine Therapy in Treating Patients With Bladder Carcinoma Who Are Undergoing Cystectomy | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label | ||||
| Condition ICMJE | Bladder Cancer | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 42 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | July 2005 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00072137 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000335473, CINJ-3909, NCI-5585 | ||||
| Study Sponsor ICMJE | Cancer Institute of New Jersey | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | January 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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