Full Text View
Tabular View
No Study Results Posted
Related Studies
Bortezomib in Treating Patients With Metastatic Kidney Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), August 2008
First Received: January 12, 2006   Last Updated: May 27, 2009   History of Changes
Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00276614
  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 II

Study Type: Interventional
Study Design: Treatment, Open Label
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 National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response rate as measured by RECIST criteria after every 2 courses of treatment for up to 6 courses [ Designated as safety issue: No ]

Estimated Enrollment: 27
Study Start Date: September 2005
Estimated Primary Completion Date: June 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

DISEASE CHARACTERISTICS:

  • 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
  • No active CNS metastases

PATIENT CHARACTERISTICS:

  • Life expectancy ≥ 3 months
  • Karnofsky performance status ≥ 60%
  • Not pregnant or nursing
  • 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
  • No myocardial infarction within the past 6 months
  • No New York Heart Association class III or IV heart failure
  • No uncontrolled angina
  • No severe uncontrolled ventricular arrhythmias
  • No electrocardiographic evidence of acute ischemia or active conduction system abnormalities
  • Peripheral neuropathy ≤ grade 1
  • No hypersensitivity to bortezomib, boron, or mannitol
  • No history of a non-RCC malignancy within the past 5 years except basal cell carcinoma of the skin
  • No serious medical or psychiatric illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • More than 30 days since any other prior investigational drugs
  • No prior cytotoxic chemotherapy for this cancer
  • No other concurrent investigational therapy
  • No concurrent chemotherapy, immunotherapy, or hormonal therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00276614

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA Recruiting
Los Angeles, California, United States, 90095-1781
Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a     888-798-0719        
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 at UCLA ( Matthew B. Rettig )
Study ID Numbers: CDR0000453541, UCLA-0412011-01, MILLENNIUM-X05145
Study First Received: January 12, 2006
Last Updated: May 27, 2009
ClinicalTrials.gov Identifier: NCT00276614     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer
recurrent renal cell cancer
papillary renal cell carcinoma

Study placed in the following topic categories:
Urinary Tract Neoplasm
Chromophil Renal Cell Carcinoma
Kidney Cancer
Bortezomib
Urogenital Neoplasms
Urologic Neoplasms
Recurrence
Protease Inhibitors
Carcinoma
Renal Cancer
Papillary Renal Cell Carcinoma
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Bortezomib
Enzyme Inhibitors
Urogenital Neoplasms
Urologic Neoplasms
Pharmacologic Actions
Protease Inhibitors
Carcinoma
Neoplasms
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 11, 2009