Bortezomib in Treating Patients With Metastatic Kidney Cancer

August 17, 2020 updated by: Jonsson Comprehensive Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Velcade
Velcade IV twice a week for two weeks on Days 1, 4, 8 and 11 of each cycle. A 10 day-rest period (Days 12-21) with no Velcade will follow the 2 weeks of treatment in each cycle. one cycle = 21 days
Drug: bortezomib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate as Measured by RECIST Criteria After Every 2 Courses of Treatment for up to 6 Courses
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

Millennium Pharmaceuticals, Inc.

Investigators

  • Study Chair: Matthew B. Rettig, MD, Jonsson Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

January 12, 2006

First Submitted That Met QC Criteria

January 12, 2006

First Posted (Estimate)

January 13, 2006

Study Record Updates

Last Update Posted (Actual)

September 1, 2020

Last Update Submitted That Met QC Criteria

August 17, 2020

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000453541
  • UCLA-0412011-01
  • MILLENNIUM-X05145

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Kidney Cancer

Clinical Trials on bortezomib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe