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A Phase II, Pharmacokinetic and Biologic Correlative Study of Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Renal Cell Carcinoma (RCC)

Phase 2
18 Years
Open (Enrolling)
Kidney Cancer

Thank you

Trial Information

A Phase II, Pharmacokinetic and Biologic Correlative Study of Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Renal Cell Carcinoma (RCC)



- Determine the antitumor activity of vorinostat (SAHA), in terms of objective response
and progression rate, in patients with advanced renal cell carcinoma.


- Evaluate the safety and tolerability of this drug, in terms of toxicity profile, in
these patients.

- Evaluate overall survival, progression-free survival, and survival rate at 12 months in
patients treated with this drug.

- Correlate changes in biologic measurements with outcomes of patients treated with this

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.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

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

- 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

- 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


- See Disease Characteristics

- 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 major surgery within the past 21 days

- No prior surgical procedures affecting absorption

- No concurrent antiretroviral therapy for HIV-positive patients

- No other concurrent investigational agents

- No other concurrent anticancer therapy

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumor activity

Safety Issue:


Principal Investigator

John Sarantopoulos, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Therapy and Research Center, Texas


United States: Food and Drug Administration

Study ID:




Start Date:

June 2006

Completion Date:

Related Keywords:

  • Kidney Cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio, Texas  78284
Cancer Therapy and Research Center San Antonio, Texas  78229
Institute for Drug Development San Antonio, Texas  78245-3217