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A Phase II Study of Bortezomib (Velcade ) Administered as a Single Agent in Metastatic Non-Clear Cell Renal Cell Carcinoma (RCC) Patients

Phase 2
18 Years
Not Enrolling
Kidney Cancer

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Trial Information

A Phase II Study of Bortezomib (Velcade ) Administered as a Single Agent in Metastatic Non-Clear Cell Renal Cell Carcinoma (RCC) Patients



- Determine, preliminarily, the efficacy of bortezomib in patients with metastatic
non-clear cell renal cell carcinoma in terms of objective response rate after a minimum
of 2 courses of treatment.


- Correlate clinical response in these patients with baseline von Hippel-Lindau
expression and nuclear factor-KB activity.

OUTLINE: This is an open-label study.

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats
every 21 days for up to 6 courses in the absence of disease progression or unacceptable

After completion of study treatment, patients are followed at 1 month and then periodically
for 2 years.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

Inclusion Criteria:

- Histologically confirmed pure non-clear cell renal cell carcinoma (RCC)

- Distant metastatic disease (Tx, Nx, M1)

- Tumor expresses wild-type von Hippel-Lindau tumor suppressor gene/protein

- Measurable disease on imaging scan (≥ 1 cm)

- Brain metastases allowed provided they have been treated with surgery and/or
radiation therapy and show no evidence of progression on cerebral CT or MRI scan 2
months following surgery and/or radiation therapy.

- Life expectancy ≥ 3 months

- Karnofsky performance status ≥ 60%

- Negative pregnancy test

- Fertile patients must use an acceptable method of contraception

- No other major illnesses likely to limit survival

- Platelet count ≥ 100,000/mm^3

- Absolute neutrophil count ≥ 1, 000/mm^3

- Hemoglobin ≥ 10 g/dL (transfusion allowed)

- Creatinine clearance ≥ 30 mL/min OR creatinine ≤ 2 mg/dL

- ALT or AST ≤ 2.5 times upper limit of normal

- At least 4 weeks since prior radiotherapy and recovered

- More than 30 days since any other prior investigational drugs

Exclusion Criteria:

- active CNS metastases

- pregnant or nursing

- myocardial infarction within the past 6 months

- New York Heart Association class III or IV heart failure

- uncontrolled angina

- severe uncontrolled ventricular arrhythmias

- electrocardiographic evidence of acute ischemia or active conduction system

- Peripheral neuropathy ≤ grade 1

- hypersensitivity to bortezomib, boron, or mannitol

- history of a non-RCC malignancy within the past 5 years except basal cell carcinoma
of the skin

- serious medical or psychiatric illness that would preclude study participation

- prior cytotoxic chemotherapy for this cancer

- other concurrent investigational therapy

- concurrent chemotherapy, immunotherapy, or hormonal therapy

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate as Measured by RECIST Criteria After Every 2 Courses of Treatment for up to 6 Courses

Outcome Time Frame:

2 months

Safety Issue:


Principal Investigator

Matthew B. Rettig, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2006

Completion Date:

July 2009

Related Keywords:

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



Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781