Brain CancerPhase 1NCT00329589
A Trial Using Velcade Plus Chemoradiation for Central Nervous System, Head and Neck, and Cervical Cancer Patients
A Phase 1 study testing Velcade (bortezomib) in people with Brain Cancer and Head and Neck Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety of Velcade when used with chemoradiation in cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Cancer, Head and Neck Cancer, Cervix Cancer
- What is being tested?
- Velcade (bortezomib)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Jun 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Equal to or greater than grade 2 peripheral neuropathy
- Myocardial infarction within 6 months
- Hypersensitivity to bortezomib, boron, or mannitol
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Phase I Open-labeled, Dose-escalation, Safety Study of the Combination of Velcade and Chemoradiation for the Treatment of Cancer Patients
The purpose of this study is to determine the safety of Velcade when used with chemoradiation in cancer patients.
Read the detailed description
- To determine the maximum tolerated dose (MTD) and a recommended phase II dose (RP2D) of Velcade® when administered as a twice weekly 3-5 second IV bolus every 3 weeks to patients with malignancies of the brain, head and neck and cervix who receive 2-8 weeks of chemoradiation.
- To evaluate the safety and toxicity profile of Velcade® when administered on a twice weekly (days 1, 4, 8 and 11) every 3 weeks (maximum 8 weeks) concurrent with chemoradiation.
- To evaluate tumor response
- Being tested
- Velcade (bortezomib)
- Keywords
- Malignancies of the central nervous system, head and neck area, and cervix
- Medical subject headings
- Brain Neoplasms, Head and Neck Neoplasms, Uterine Cervical Neoplasms, Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Velcade (bortezomib)Drug
| Study group | Role | What they receive |
|---|---|---|
| CNS | Experimental | Velcade (bortezomib) Receives: Drug: Velcade (bortezomib) |
| Head and Neck | Experimental | Velcade (bortezomib) Receives: Drug: Velcade (bortezomib) |
| Cervix | Experimental | Velcade (bortezomib) Receives: Drug: Velcade (bortezomib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2006 (estimated)
- Study startSep 2005
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Adam Dicker, MD, PhD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329589
- Sponsor's protocol ID
- 05C.255
- Other IDs
- 2005-28, NCI-2009-01797, JT 1133
- Status last verified
- May 2025
- First submitted
- 24 May 2006
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-labeled, Dose-escalation, Safety Study of the Combination of Velcade and Chemoradiation for the Treatment of Cancer Patients
- ClinicalTrials.gov ID
- NCT00329589
- Acronym / sponsor ID
- 05C.255
- Keywords
- Malignancies of the central nervous system, head and neck area, and cervix
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- Sep 2005
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 25 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety of Velcade when used with chemoradiation in cancer patients.
Detailed description
- To determine the maximum tolerated dose (MTD) and a recommended phase II dose (RP2D) of Velcade® when administered as a twice weekly 3-5 second IV bolus every 3 weeks to patients with malignancies of the brain, head and neck and cervix who receive 2-8 weeks of chemoradiation.
- To evaluate the safety and toxicity profile of Velcade® when administered on a twice weekly (days 1, 4, 8 and 11) every 3 weeks (maximum 8 weeks) concurrent with chemoradiation.
- To evaluate tumor response
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CNS | Experimental | Drug: Velcade (bortezomib)Velcade (bortezomib) |
| Head and Neck | Experimental | Drug: Velcade (bortezomib)Velcade (bortezomib) |
| Cervix | Experimental | Drug: Velcade (bortezomib)Velcade (bortezomib) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Equal to or greater than grade 2 peripheral neuropathy
- Myocardial infarction within 6 months
- Hypersensitivity to bortezomib, boron, or mannitol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Velcade (bortezomib) | Drug | CNS, Cervix, Head and Neck |
Primary outcome
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
Time frame: 2-8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Kimmel Cancer Center at Thomas Jefferson UniversityLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Dicker, MD, PhD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Velcade (bortezomib) in people with Brain Cancer and Head and Neck Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 2-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.