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Bortezomib in Treating Patients With Metastatic Kidney Cancer

Primary Purpose

Kidney Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bortezomib
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage IV renal cell cancer, recurrent renal cell cancer, papillary renal cell carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center at UCLA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Velcade

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 12, 2006
Last Updated
August 17, 2020
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Millennium Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00276614
Brief Title
Bortezomib in Treating Patients With Metastatic Kidney Cancer
Official Title
A Phase II Study of Bortezomib (Velcade ) Administered as a Single Agent in Metastatic Non-Clear Cell Renal Cell Carcinoma (RCC) Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Millennium Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
stage IV renal cell cancer, recurrent renal cell cancer, papillary renal cell carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Velcade
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
bortezomib
Primary Outcome Measure Information:
Title
Objective Response Rate as Measured by RECIST Criteria After Every 2 Courses of Treatment for up to 6 Courses
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew B. Rettig, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States

12. IPD Sharing Statement

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Bortezomib in Treating Patients With Metastatic Kidney Cancer

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