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Gene Therapy in Treating Patients With Advanced Bladder Cancer
This study has been completed.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003167
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Biological: Ad5CMV-p53 gene
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Trial of Intravesical Ad-p53 Treatment in Locally Advanced and Metastatic Bladder Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 1998
Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003167

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Lance C. Pagliaro, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
Pagliaro LC, Keyhani A, Liu B, et al.: Gene therapy in bladder cancer: phase I results with Ad5CMV-p53 (RPR/INGN 201). [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-799, 2001.

Study ID Numbers: CDR0000065968, MDA-DM-96172, NCI-T96-0073
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00003167     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I bladder cancer
stage II bladder cancer
stage III bladder cancer
recurrent bladder cancer
stage IV bladder cancer
transitional cell carcinoma of the bladder

Study placed in the following topic categories:
Urinary Tract Neoplasm
Cystocele
Urologic Diseases
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Urogenital Neoplasms
Bladder Neoplasm
Urologic Neoplasms
Carcinoma, Transitional Cell
Recurrence
Transitional Cell Carcinoma
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Urologic Diseases
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Urogenital Neoplasms
Urologic Neoplasms

ClinicalTrials.gov processed this record on September 02, 2009