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Vorinostat in Treating Patients With Locally Recurrent or Metastatic Cancer of the Urothelium | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Vorinostat in Treating Patients With Locally Recurrent or Metastatic Cancer of the Urothelium

Phase II Study of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Recurrent or Metastatic Transitional Cell Carcinoma of the Urothelium

NCT00363883•National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well vorinostat works in treating patients with locally recurrent or metastatic cancer of the urothelium.

Detailed Description

PRIMARY OBJECTIVES: I. To determine response rate measured by RECIST criteria for SAHA in patients with recurrent or metastatic transitional cell carcinoma of the urothelium. SECONDARY OBJECTIVES: I. To determine the time to progression and overall survival for SAHA in patients with recurrent or metastatic transitional cell carcinoma of the urothelium. II. To provide data on safety and toxicity of SAHA in patients with recurrent or metastatic transitional cell carcinoma of the urothelium. III. To obtain preliminary data on molecular correlates in tissue, oral mucosa and blood to determine feasibility and clinical efficacy. OUTLINE: This is a multicenter study. Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood and buccal mucosa collection and tumor biopsies (if accessible) at baseline and periodically during study for correlative studies. Samples are examined by gene expression profiling and immunohistochemistry. After completion of study treatment, patients are followed for up to 26 weeks. PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have a pathological diagnosis of transitional cell carcinoma of the bladder or urothelium with less than 25% component of other cell types such as small cell, neuroendocrine or squamous cell carcinoma; archival tumor tissue must be available for classification and correlates as described in this protocol or otherwise the patient must be willing to undergo biopsy prior to trial entry
•Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral CT scan; patients with boney metastases are allowed to participate in the study provided they also have non-osseous disease that is measurable
•Patients must have recurred or progressed on or subsequent to platinum-based chemotherapy in the adjuvant or advanced setting; patients treated with a second line of chemotherapy may be included provided more than six months elapsed from the completion of the first line of chemotherapy to the start of the second; patients may have had any number of prior intravesical therapies for superficial bladder cancer; patients may also have had one experimental biologic therapy for their metastatic urothelial cancer provided this was not an agent known to act through histone deacetylation or demethylation; these compounds include sodium butyrate, trichostatin A (TSA), trapoxin (TPX), MS-27-275 and depsipeptide
•Life expectancy of greater than 3 months
•ECOG performance status =\< 2 (Karnofsky \>= 60%)
•Absolute neutrophil count \>= 1,500/mcL
•Platelets \>= 100,000/mcL
•Total bilirubin within normal institutional limits
•AST (SGOT)/ALT (SGPT) =\< 2.5 x institutional upper limit of normal unless there are liver metastases in which case AST/ALT must be =\< 5 x the upper limits of institutional normal
•Creatinine =\< 1.5 times normal institutional limits OR creatinine clearance \>= 40 mL/min/1.73 m\^2 for patients with creatinine levels above 1.5 times institutional normal
+3 more criteria

Exclusion Criteria

•Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
•Patients may not be receiving any other investigational agents
•Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to SAHA; these compounds include sodium butyrate, trichostatin A (TSA), trapoxin (TPX), MS-27-275 and depsipeptide
•Prior treatment with more than 2 cytotoxic chemotherapy regimens for urothelial transitional cell cancer
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
•Pregnant women are excluded from this stud; breastfeeding should be discontinued if the mother is treated with SAHA
•HIV-positive patients receiving combination antiretroviral therapy are ineligible
•Patients should not have taken valproic acid for at least two weeks prior to study entry

Locations (1)

University of Southern California, Norris

Los Angeles, California, United States

Key Dates

Start Date

June 1, 2006

Primary Completion Date

December 1, 2010

Completion Date

December 1, 2010

Last Updated

February 13, 2015

Enrollment

ACTUAL participants

Conditions

Localized Transitional Cell Cancer of the Renal Pelvis and UreterMetastatic Transitional Cell Cancer of the Renal Pelvis and UreterRecurrent Transitional Cell Cancer of the Renal Pelvis and UreterRegional Transitional Cell Cancer of the Renal Pelvis and UreterTransitional Cell Carcinoma of the Bladder

Interventions

vorinostat

DRUG

laboratory biomarker analysis

OTHER

Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers

NCT01846520

Healthy SubjectLocalized Transitional Cell Cancer of the Renal Pelvis and Ureter+82 more

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COMPLETEDPHASE2

Pazopanib in Treating Patients With Metastatic Urothelial Cancer

NCT00471536

Distal Urethral CancerProximal Urethral Cancer+6 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Vorinostat in Treating Patients With Locally Recurrent or Metastatic Cancer of the Urothelium

Inclusion Criteria

Exclusion Criteria

Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers

Pazopanib in Treating Patients With Metastatic Urothelial Cancer

Trastuzumab in Treating Patients With Previously Treated, Locally Advanced, or Metastatic Cancer of the Urothelium