Status:
COMPLETED
Vorinostat in Treating Patients With Kidney Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Renal Cell Carcinoma
Stage IV Renal Cell Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 OBJECTIVE...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00278395
Start Date
October 1 2005
End Date
February 1 2010
Last Update
November 14 2017
Active Locations (2)
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1
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
2
Institute for Drug Development
San Antonio, Texas, United States, 78245