RATIONALE: Inserting the p53 gene into a person's bladder cancer cells may improve the body's ability to fight cancer.

PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients with advanced bladder cancer.

OBJECTIVES: I. Determine the safety and toxicity of adenovirus p53 (Ad-p53) gene therapy in patients with locally advanced or metastatic bladder cancer. II. Measure infection with Ad-p53 and confirm expression of p53 after infection. III. Characterize clinical response of measurable tumor in these patients. IV. Determine the duration of effect of this treatment in these patients. V. Define the time course of elimination of vector from urinary bladder.

OUTLINE: This is a dose escalation study. Group 1 patients receive adenovirus p53 (Ad-p53) intravesically on days 1 and 4. Treatment continues every 4 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3 patients in group 1 receive escalating doses of Ad-p53. In the absence of grade 3 or worse toxicity in the first 3 patients treated, subsequent cohorts of 3 patients each receive escalating doses of Ad-p53 on the same schedule. If 1 of 3 patients experiences grade 3 toxicity, an additional 3 patients are treated at that dose level and dose escalation continues. If 1 of 3 patients experience grade 4 toxicity or 2 of 3 patients experience grade 3 toxicity, dose escalation ceases and the MTD is defined as the previous dose level. Group 2 patients receive Ad-p53 at the MTD on days 1-4, and group 3 patients receive Ad-p53 at the MTD on days 1-4 and 8-11. Patients are followed on day 28, then every 3 months for 1 year or until disease progression.

PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study (3-12 patients for group 1; 3-6 patients for group 2; and 6 patients for group 3).

DISEASE CHARACTERISTICS: Histologically confirmed transitional cell carcinoma of the bladder with muscle invasion or lamina propria invasion (T1-4) Patients without muscle invasion (T1) must have concurrent carcinoma in situ (CIS)or recurrent/persistent tumor following at least 1 course of intravesical BCG immunotherapy OR Patients who have received BCG and have only CIS are eligible if lesions are sufficiently raised and measurable Bidimensionally measurable disease Unresectable locally advanced disease OR Asymptomatic distant visceral metastases OR Refused cystectomy Recurrent disease after prior chemotherapy OR Patients with muscle invasion must have failed prior cisplatin-based chemotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Must have at least minimal control of bladder function (NCI grade 3 incontinence not eligible) Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception HIV negative No active viral, bacterial, or fungal infection requiring treatment No serious concurrent illness or psychological, familial, sociological, geographical, or other conditions that would prevent compliance Urine culture (14-day) negative for adenovirus

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior gene therapy Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea) and recovered Endocrine therapy: Not specified Radiotherapy: At least 6 weeks since prior radiotherapy Surgery: No prior transurethral resection if all visible tumor removed Partial resection for diagnosis allowed Other: No other concurrent investigational agents