Bortezomib in Treating Patients With Metastatic Kidney Cancer

Kidney Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00276614
• Other study ID #: CDR0000453541
• Secondary ID: UCLA-0412011-01M
• Status: Completed
• Phase: Phase 2
• Start date: April 2006
• Est. completion date: July 2009

Study information

• Verified date: July 2012
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with metastatic kidney cancer.

Description:

OBJECTIVES:

Primary

• 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.

Secondary

• 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 toxicity.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 abnormalities

• 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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Drug:
• bortezomib

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	Millennium Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate as Measured by RECIST Criteria After Every 2 Courses of Treatment for up to 6 Courses		2 months