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Vorinostat in Treating Patients With Kidney Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00278395
First received: January 16, 2006
Last updated: May 21, 2014
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Recurrent Renal Cell Cancer
Stage IV Renal Cell Cancer
Drug: vorinostat
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Pharmacokinetic and Biologic Correlative Study of Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Renal Cell Carcinoma (RCC)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective Response [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Overall Survival (OS) and Median OS [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Safety and Tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: October 2005
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Given orally
Other Names:
  • L-001079038
  • SAHA
  • suberoylanilide hydroxamic acid
  • Zolinza

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00278395

Locations
United States, Texas
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Institute for Drug Development
San Antonio, Texas, United States, 78245
Sponsors and Collaborators
Investigators
Principal Investigator: John Sarantopoulos Institute for Drug Development
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00278395     History of Changes
Other Study ID Numbers: NCI-2009-00087, NCI-2009-00087, CDR0000456500, #04-10, 6825, U01CA069853
Study First Received: January 16, 2006
Results First Received: December 7, 2012
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Vorinostat
Antineoplastic Agents
Enzyme Inhibitors
Histone Deacetylase Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014