Bortezomib in Treating Patients With Metastatic Kidney Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00276614
First received: January 12, 2006
Last updated: July 27, 2012
Last verified: July 2012
  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: 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 ] [ Designated as safety issue: No ]

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)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Study Chair: Matthew B. Rettig, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00276614     History of Changes
Other Study ID Numbers: CDR0000453541, P30CA016042, UCLA-0412011-01, MILLENNIUM-X05145
Study First Received: January 12, 2006
Results First Received: March 27, 2012
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Jonsson Comprehensive Cancer Center:
stage IV renal cell cancer
recurrent renal cell cancer
papillary renal cell carcinoma

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Kidney Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Bortezomib
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014