Vorinostat in Treating Patients With Kidney Cancer

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2010-02-28

Brief Summary

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This phase II trial is studying how well vorinostat works in treating patients with advanced kidney cancer. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking blood flow to the tumor.

Detailed Description

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PRIMARY OBJECTIVES:

I. Determine the antitumor activity of vorinostat (SAHA), in terms of objective response and progression rate, in patients with advanced renal cell carcinoma.

SECONDARY OBJECTIVES:

I. Evaluate the safety and tolerability of this drug, in terms of toxicity profile, in these patients.

II. Evaluate overall survival, progression-free survival, and survival rate at 12 months in patients treated with this drug.

III. Correlate changes in biologic measurements with outcomes of patients treated with this drug.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral vorinostat (SAHA) twice daily on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Patients may have the option of continuing treatment beyond 52 weeks at the discretion of the investigator.

After completion of study treatment, patients are followed within 1 month and then approximately every 2 months thereafter.

Conditions

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Recurrent Renal Cell Carcinoma Stage IV Renal Cell Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I

Patients receive oral vorinostat (SAHA) twice daily on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Patients may have the option of continuing treatment beyond 52 weeks at the discretion of the investigator.

Group Type EXPERIMENTAL

Vorinostat

Intervention Type DRUG

Given orally

Interventions

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Vorinostat

Given orally

Intervention Type DRUG

Other Intervention Names

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L-001079038 SAHA Suberanilohydroxamic Acid Suberoylanilide Hydroxamic Acid Zolinza

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed diagnosis of advanced renal cell carcinoma that is either metastatic or inoperable
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
* Disease is recurrent or refractory to interleukin-2 (IL-2) or interferon-based therapy OR new diagnosis in previously untreated patients who are not appropriate candidates to receive IL-2 based treatment
* Patients who have failed up to 4 lines of prior immunotherapy or biological therapy allowed
* No known brain metastases or leptomeningeal disease
* Stable brain metastases or curatively resected brain metastases without neurologic dysfunction for ≥ 6 months allowed
* ECOG performance status 0-2 OR Karnofsky 70-100%
* Life expectancy ≥ 12 weeks
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9.0 g/dL
* Serum creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance \> 50 mL/min
* Total bilirubin within normal limits
* AST/ALT ≤ 2.5 times ULN (≤ 5 times ULN if liver metastasis is present)
* No history of active malignancy (other than renal cell carcinoma) within the past 3 years other than nonmelanomatous skin cancer, in situ breast cancer, or in situ cervical cancer
* No history of allergic reactions to compounds of similar chemical or biological composition to vorinostat (SAHA)
* No uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
* No psychiatric illness or social situation that would preclude study compliance
* No clinically significant hypercalcemia
* No significant traumatic injury within the past 21 days
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No gastrointestinal disease resulting in an inability to take oral medication
* No requirement for IV alimentation
* No active peptic ulcer disease
* Recovered from prior therapy
* Prior nephrectomy or resection of metastatic lesions allowed provided full surgical recovery has occurred
* No chemotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin)
* No radiotherapy within the past 4 weeks
* No valproic acid for at least 2 weeks prior to study enrollment
* No prior surgical procedures affecting absorption
* No major surgery within the past 21 days
* No concurrent antiretroviral therapy for HIV-positive patients
* No other concurrent investigational agents
* No other concurrent anticancer therapy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Sarantopoulos

Role: PRINCIPAL_INVESTIGATOR

Institute for Drug Development

Locations

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Cancer Therapy and Research Center at The UT Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status

Institute for Drug Development

San Antonio, Texas, United States

Site Status

Countries

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United States