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Bortezomib in Treating Patients With Metastatic Kidney Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00276614
First Posted: January 13, 2006
Last Update Posted: November 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
  Purpose

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 Intervention Phase
Kidney Cancer Drug: bortezomib Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • Objective Response Rate as Measured by RECIST Criteria After Every 2 Courses of Treatment for up to 6 Courses [ Time Frame: 2 months ]

Enrollment: 4
Study Start Date: April 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276614


Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Matthew B. Rettig, MD Jonsson Comprehensive Cancer Center
  More Information

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00276614     History of Changes
Other Study ID Numbers: CDR0000453541
P30CA016042 ( U.S. NIH Grant/Contract )
UCLA-0412011-01
MILLENNIUM-X05145
First Submitted: January 12, 2006
First Posted: January 13, 2006
Results First Submitted: March 27, 2012
Results First Posted: April 19, 2012
Last Update Posted: November 24, 2015
Last Verified: July 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
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Bortezomib
Antineoplastic Agents