Neoadjuvant Intravesical Vaccine Therapy in Treating Patients With Bladder Carcinoma Who Are Undergoing Cystectomy
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bladder Cancer
Intervention: recombinant fowlpox GM-CSF vaccine adjuvant (Drug); recombinant fowlpox-TRICOM vaccine (Drug); conventional surgery (Procedure); neoadjuvant therapy (Procedure)
Phase: Phase 1
Status: Recruiting
Sponsored by: Cancer Institute of New Jersey Official(s) and/or principal investigator(s):
Edmund C. Lattime, PhD, Study Chair, Affiliation: Cancer Institute of New Jersey
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.
Clinical Details
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
Study design: Treatment, Open Label
Detailed description:
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 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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
- No history of liver disease and/or history of hepatitis that may suggest persistent
disease
- SGOT less than 2 times normal
- Bilirubin less than 2. 0 mg/dL
- No presence of liver function abnormalities
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 prior exposure to liver toxins
- No ongoing alcohol consumption or exposure to other liver toxins
- 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 acetaminophen
- No concurrent active antibiotic therapy except as prophylaxis
- No concurrent immunosuppressive therapy
Locations and Contacts
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey 08903, United States; Recruiting
Clinical Trials Office - Cancer Institute of New Jersey, Phone: 732-235-8675
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: October 2003
Last updated: July 23, 2008
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