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CompletedNCT00278395Updated Nov 14, 2017Results posted

Vorinostat in Treating Patients With Kidney Cancer

A Phase 2 interventional study of Vorinostat in Recurrent Renal Cell Carcinoma and Stage IV Renal Cell Cancer, sponsored by National Cancer Institute (NCI). Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-14.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Recurrent Renal Cell Carcinoma
  • Stage IV Renal Cell Cancer
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 14 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    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.

    Drug: Vorinostat

Interventions

  • DrugVorinostat

    Given orally

    Also known as: L-001079038, SAHA, Suberanilohydroxamic Acid, Suberoylanilide Hydroxamic Acid, Zolinza

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

Secondary outcomes

  1. Progression-free Survival

    Time frame: 1 year

  2. Overall Survival (OS) and Median OS

    Time frame: 1 year

  3. Safety and Tolerability

    Time frame: 1 year

07

Results

Posted Aug 30, 2013

Participant flow

Open to recruitment on 12/5/2005, closed to recruitment on 3/3/09 at The University of Texas Health Science Center San Antonio at Cancer and Therapy Research Center

Participant flow — Overall Study
MilestoneVorinostat
Started14
Completed11
Not completed3
Withdrew: Adverse event2
Withdrew: Nonevaluable1

Outcome measures

PrimaryObjective 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.

Time frame:
1 year
Reported as:
Number · participants
Objective Response
participantsVorinostat
Best Objective Response Rate (ORR)4
Progressive Disease7
SecondaryProgression-free Survival
Time frame:
1 year

No measurements were reported for this outcome.

SecondaryOverall Survival (OS) and Median OS
Time frame:
1 year

No measurements were reported for this outcome.

SecondarySafety and Tolerability
Time frame:
1 year

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Vorinostat—1/14 (7.1%)7/14 (50%)
Most frequent serious events
Most frequent serious events
EventVorinostat
Shortness of BreathRespiratory, thoracic and mediastinal disorders1/14
Congestive Heart FailureCardiac disorders1/14
Most frequent other events
Most frequent other events
EventVorinostat
NauseaGastrointestinal disorders7/14
FatigueBlood and lymphatic system disorders7/14
Weight lossGastrointestinal disorders6/14
DiarrheaGastrointestinal disorders4/14
VomitingGastrointestinal disorders4/14

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Vorinostat
<=18 years0
Between 18 and 65 years12
>=65 years2
Age, Continuous
Age, Continuous(years)Vorinostat
Mean60 ± 2
Sex: Female, Male
Sex: Female, Male(Participants)Vorinostat
Female5
Male9
Region of Enrollment
Region of Enrollment(participants)Vorinostat
United States14
08

Study locations

2 sites
  • Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
    San Antonio, Texas 78229, United States
  • Institute for Drug Development
    San Antonio, Texas 78245, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00278395
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 18, 2006
Start date
Oct 2005
Primary completion
Feb 2010
Completion
Feb 2010
Results posted
Aug 30, 2013
Last update
Nov 14, 2017

Study contacts

John Sarantopoulos
principal investigator · Institute for Drug Development
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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