Neoadjuvant Intravesical Vaccine Therapy in Treating Patients With Bladder Carcinoma Who Are Undergoing Cystectomy
This study is currently recruiting patients.
Sponsored by: |
Cancer Institute of New Jersey
|
Information provided by: |
National Cancer Institute (NCI) |
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: Phase I trial to study the effectiveness of neoadjuvant intravesical vaccine therapy in treating patients who are
undergoing cystectomy for bladder carcinoma (cancer).
Condition
|
Treatment or Intervention |
Phase |
Bladder Cancer
|
Drug: fowlpox-TRICOM vaccine Drug: recombinant fowlpox GM-CSF vaccine Procedure: biological response modifier therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: recombinant viral vaccine Procedure: surgery Procedure: vaccine therapy
|
Phase I
|
MedlinePlus related topics: Bladder Cancer
Genetics Home Reference related topics: bladder cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of Neoadjuvant Intravesical Recombinant Fowlpox-TRICOM Vaccine and/or Recombinant Fowlpox-Sargramostim Vaccine
in Patients With Bladder Carcinoma Undergoing Cystectomy
Further Study 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
Genders Eligible for Study:
Both
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
Performance status
Life expectancy
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
Other
- Recovered from prior therapy
- No concurrent active antibiotic therapy except as prophylaxis
- No concurrent immunosuppressive therapy
Location
and Contact
Information
New Jersey Cancer Institute of New Jersey at Robert Wood Johnson University Hospital, New Brunswick,
New Jersey,
08901,
United States; Recruiting
Study chairs or principal investigators
Edmund Lattime, PhD, Study Chair, Cancer Institute of New Jersey
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers:
CDR0000335473; CINJ-3909; NCI-5585
Record last reviewed:
July 2004
Record first received:
November 4, 2003
ClinicalTrials.gov Identifier:
NCT00072137Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-11-17