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Vorinostat in Treating Patients With Kidney Cancer

Primary Purpose

Recurrent Renal Cell Carcinoma, Stage IV Renal Cell Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vorinostat
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Renal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
  • Institute for Drug Development

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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.

Outcomes

Primary Outcome Measures

Objective Response
Objective response is measured using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST criteria. Complete Response (CR) - Disappearance of all target lesions, Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, Progressive Disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, Stable Disease (SD) - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Secondary Outcome Measures

Progression-free Survival
Overall Survival (OS) and Median OS
Safety and Tolerability

Full Information

First Posted
January 16, 2006
Last Updated
October 13, 2017
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00278395
Brief Title
Vorinostat in Treating Patients With Kidney Cancer
Official Title
A Phase II, Pharmacokinetic and Biologic Correlative Study of Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Renal Cell Carcinoma (RCC)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Renal Cell Carcinoma, Stage IV Renal Cell Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vorinostat
Other Intervention Name(s)
L-001079038, SAHA, Suberanilohydroxamic Acid, Suberoylanilide Hydroxamic Acid, Zolinza
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
Objective Response
Description
Objective response is measured using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST criteria. Complete Response (CR) - Disappearance of all target lesions, Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, Progressive Disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, Stable Disease (SD) - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Progression-free Survival
Time Frame
1 year
Title
Overall Survival (OS) and Median OS
Time Frame
1 year
Title
Safety and Tolerability
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Sarantopoulos
Organizational Affiliation
Institute for Drug Development
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Institute for Drug Development
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78245
Country
United States

12. IPD Sharing Statement

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Vorinostat in Treating Patients With Kidney Cancer

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