NCT00329589

Brief Summary

The purpose of this study is to determine the safety of Velcade when used with chemoradiation in cancer patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_1

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

Study Start

First participant enrolled

September 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 25, 2006

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

May 2, 2025

Status Verified

May 1, 2025

Enrollment Period

4.8 years

First QC Date

May 24, 2006

Last Update Submit

May 1, 2025

Conditions

Brain CancerHead and Neck CancerCervix CancerCentral Nervous System Neoplasms

Keywords

Malignancies of the central nervous system, head and neck areaand cervix

Outcome Measures

Primary Outcomes (1)

  • To determine the safe and maximum tolerated dose of Velcade® when administered as a twice weekly 3-5 second intravenous (IV) bolus every 3 weeks to patients with malignancies of the brain, head and neck, and cervix who receive 2-8 weeks of radiotherapy

    2-8 weeks

Study Arms (3)

CNS

EXPERIMENTAL

Velcade (bortezomib)

Drug: Velcade (bortezomib)

Head and Neck

EXPERIMENTAL

Velcade (bortezomib)

Drug: Velcade (bortezomib)

Cervix

EXPERIMENTAL

Velcade (bortezomib)

Drug: Velcade (bortezomib)

Interventions

Velcade (bortezomib)DRUG
CNSCervixHead and Neck

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed malignancy
  • Requiring at least grade 2 weeks of radiation therapy
  • Solid tumors of the central nervous system, head and neck area, and cervix
  • World Health Organization (WHO) performance status equal to or less than 2

You may not qualify if:

  • Equal to or greater than grade 2 peripheral neuropathy
  • Myocardial infarction within 6 months
  • Hypersensitivity to bortezomib, boron, or mannitol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

MeSH Terms

Conditions

Brain NeoplasmsHead and Neck NeoplasmsUterine Cervical NeoplasmsCentral Nervous System Neoplasms

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Adam Dicker, MD, PhD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2006

First Posted

May 25, 2006

Study Start

September 1, 2005

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

May 2, 2025

Record last verified: 2025-05

Locations

US(1)