NCT00276614

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

April 19, 2012

Completed
Last Updated

September 1, 2020

Status Verified

July 1, 2012

Enrollment Period

3.3 years

First QC Date

January 12, 2006

Results QC Date

March 27, 2012

Last Update Submit

August 17, 2020

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancerrecurrent renal cell cancerpapillary renal cell carcinoma

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate as Measured by RECIST Criteria After Every 2 Courses of Treatment for up to 6 Courses

    2 months

Study Arms (1)

Velcade

EXPERIMENTAL

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

Interventions

bortezomibDRUG
Velcade

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +2 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

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

Results Point of Contact

Title
Matthew Rettig, M.D.
Organization
David Geffen School of Medicine at UCLA
mrettig@mednet.ucla.edu
310-794-3565

Study Officials

  • Matthew B. Rettig, MD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 13, 2006

Study Start

April 1, 2006

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

September 1, 2020

Results First Posted

April 19, 2012

Record last verified: 2012-07

Locations

US(1)