Overview

This trial is active, not recruiting.

Conditions recurrent renal cell cancer, stage iv renal cell cancer
Treatment vorinostat
Phase phase 2
Target HDAC
Sponsor National Cancer Institute (NCI)
Start date October 2005
End date February 2010
Trial size 14 participants
Trial identifier NCT00278395, #04-10, 6825, CDR0000456500, NCI-2009-00087, U01CA069853

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
vorinostat L-001079038
Given orally

Primary Outcomes

Measure
Objective Response
time frame: 1 year

Secondary Outcomes

Measure
Progression-free Survival
time frame: 1 year
Overall Survival (OS) and Median OS
time frame: 1 year
Safety and Tolerability
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase II, Pharmacokinetic and Biologic Correlative Study of Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Renal Cell Carcinoma (RCC)
Principal investigator John Sarantopoulos
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).