Clinical trial NCT00276614: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Cancer
Keywords: stage IV renal cell cancer
recurrent renal cell cancer
papillary renal cell carcinoma
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Millennium Pharmaceuticals, Inc.
First posted: 2006-01-13
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Objective Response Rate as Measured by RECIST Criteria After Every 2 Courses of Treatment for up to 6 Courses
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center at UCLA
state: California
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Matthew B. Rettig, MD
role: STUDY_CHAIR
References: