Bortezomib in Treating Patients With Metastatic Kidney Cancer

• Sponsor: Jonsson Comprehensive Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00276614
• Collaborator: Millennium Pharmaceuticals, Inc. (Industry)
• Enrollment: 4
• Location: 1
• Arm: 1
• Duration (Months): 39
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Cancer	Drug: bortezomib	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Apr 1, 2006
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Objective Response Rate as Measured by RECIST Criteria After Every 2 Courses of Treatment for up to 6 Courses [2 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California	United States	90095-1781

Sponsors and Collaborators

• Jonsson Comprehensive Cancer Center
• Millennium Pharmaceuticals, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jonsson Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT00276614
• Other Study ID Numbers: CDR0000453541; UCLA-0412011-01; MILLENNIUM-X05145
• First Posted: Jan 13, 2006
• Last Update Posted: Sep 1, 2020
• Last Verified: Jul 1, 2012

• Keywords provided by Jonsson Comprehensive Cancer Center: stage IV renal cell cancer; recurrent renal cell cancer; papillary renal cell carcinoma
• Additional relevant MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell; Bortezomib

Study Results

Participant Flow

Recruitment Details	Recruitment period from April 2006 through May 2009 at outpatient oncology clinic.

Arm/Group Title	Bortezomib
Arm/Group Description	Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.
Period Title: Overall Study
STARTED	4
COMPLETED	1
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Bortezomib
Arm/Group Description	Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.
Overall Participants	4
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	42
Sex: Female, Male (Count of Participants)
Female	1 25%
Male	3 75%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	4 100%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

2 subjects were excluded from analysis as they completed less than 2 cycles of study therapy.

Arm/Group Title	Bortezomib
Arm/Group Description	Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.
Measure Participants	2
Number [participants]	2 50%

Adverse Events

Time Frame	Beginning of treatment through 30 days post last treatment.
Arm/Group Title	Bortezomib
Arm/Group Description	Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.
All Cause Mortality
	Bortezomib
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Bortezomib
	Affected / at Risk (%)	# Events
Total	0/4 (0%)
Other (Not Including Serious) Adverse Events
	Bortezomib
	Affected / at Risk (%)	# Events
Total	2/4 (50%)
Blood and lymphatic system disorders
Thrombocytopenia	1/4 (25%)	1
Gastrointestinal disorders
Nausea	1/4 (25%)	1
Vomiting	1/4 (25%)	1

Limitations/Caveats

Approval of several agents for management of renal cell carcinoma rendered accrual to this trial quite difficult.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.