Nasopharyngeal CarcinomaPhase 2NCT00367718
Trial of VELCADE in Patients With Metastatic or Locally Recurrent Nasopharyngeal Carcinoma
A Phase 2 study testing Velcade in people with Nasopharyngeal Carcinoma, run by Johns Hopkins University at 3 sites in 2 countries.
Trial summary
This study seeks to test the Efficacy in terms of rates of disease response in metastatic nasopharyngeal carcinoma of the standard dose of velcade 1.3 mg/m2 given at the day 1,4,8,and 11 every 21 days schedule. The study uses a Simons 2 stage design and will enroll between 15-25 patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Velcade
- How many people
- 0 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proven nasopharyngeal carcinoma - WHO type 3 (recurrence or metastases)
- metastatic disease or locally recurrent disease not amendable curative therapy
- Patients must have measurable disease
- least one (not more than a total of three prior lines of chemotherapy for metastatic or recurrent disease). This must include at least 1 prior line of platinum-containing chemotherapy.
- An ECOG performance status of 0-2
- Absolute neutrophil count (ANC) ≥1500/mm3
Show all 17Show fewer
- Hemoglobin 8g/dl (blood transfusion is allowed to correct hemoglobin level).
- PLT ≥ 75,000/mm 3
- Total bilirubin ≤ 2 x upper normal limit (UNL)
- Serum ALT ≤ 5 x UNL
- Serum creatinine ≤ 2 mg/dL
- Serum albumin ≥ 2.5 g/dL
- No known history of brain or leptomeningeal metastasis.
- ≥ 18 years of age.
- Estimated life expectancy ≥ 24 weeks.
- For sexually active women of childbearing potential, negative pregnancy test within 21 days of enrolling on trial.
- must be able to give informed written consent
Who cannot join
- Patients who have not had at least 1 or more than 3 previous lines of treatment for metastatic or recurrent NPC
- Prior BORTEZOMIB therapy
- Immunotherapy ≤ 4 weeks have elapsed prior to study entry
- Biologic therapy ≤ 4 weeks have elapsed prior to study entry
- Radiation therapy ≤ 4 weeks have elapsed prior to study entry
- Major surgery, or significant traumatic injury ≤3 weeks prior to study entry
Show all 15Show fewer
- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any other therapy or supportive care considered investigational
- Evidence of CNS involvement
- Presence of > grade 1 sensory peripheral neuropathy of any etiology OR grade 1 with neuropathic pain of any etiology.
- Patients with significant local symptoms from metastases which is amenable to radiotherapy
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to BORTEZOMIB.
- History of other malignancy ≤ 3 years prior to study entry, except for adequately treated basal cell, squamous cell skin cancer or cervical intraepithelial neoplasia.
- Uncontrolled intercurrent illness
- Patients who are pregnant or breast feeding (Sexually active men and women of childbearing potential must use contraception during course of therapy and within 3 months of completion of trial) Participation in another clinical trial involving therapeutic intervention within 4 weeks of enrollment.
- Known history of HIV
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Singapore2 sites
Johns Hopkin Singapore International Medical Center
Singapore
National University Hospital of Singapore
Singapore
About this study
Official title: A Phase II Trial of VELCADE in Patients With Metastatic or Locally Recurrent Nasopharyngeal Carcinoma
This study seeks to test the Efficacy in terms of rates of disease response in metastatic nasopharyngeal carcinoma of the standard dose of velcade 1.3 mg/m2 given at the day 1,4,8,and 11 every 21 days schedule. The study uses a Simons 2 stage design and will enroll between 15-25 patients. Secondary endpoints studied include Pharmacokinetics, toxicities, EBV viral load and molecular characterization of EBV in plasma.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Velcade
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VelcadeDrug
velcade 1.3 mg/m2 given at the day 1,4,8,and 11 every 21 days schedule.
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy based on response of measurable disease
Measured: duration of study (4 -6 months)
Secondary outcomes (3)
EBV viral load
Measured: duration of study (4 -6 months)
toxicities
Measured: duration of study (4 -6 months)
molecular characterization of EBV in Plasma
Measured: duration of study (4 -6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2006 (estimated)
Why it stopped: PI left JHU and is not able to be reached for updates
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen-Cilag Ltd.
- Responsible party
- Sponsor
- Investigators
- Wen-son Hsieh, M.D., Study chair, Johns Hopkins Singapore-International Medical CenterBrigette Ma, M.D., Study chair, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367718
- Sponsor's protocol ID
- CTRG-NP04/23/06
- Status last verified
- May 2019
- First submitted
- 21 Aug 2006
- Last updated
- 18 May 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of VELCADE in Patients With Metastatic or Locally Recurrent Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT00367718
- Acronym / sponsor ID
- CTRG-NP04/23/06
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left JHU and is not able to be reached for updates
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Janssen-Cilag Ltd.
- First posted
- 23 Aug 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.
This study seeks to test the Efficacy in terms of rates of disease response in metastatic nasopharyngeal carcinoma of the standard dose of velcade 1.3 mg/m2 given at the day 1,4,8,and 11 every 21 days schedule. The study uses a Simons 2 stage design and will enroll between 15-25 patients. Secondary endpoints studied include Pharmacokinetics, toxicities, EBV viral load and molecular characterization of EBV in plasma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Biopsy proven nasopharyngeal carcinoma - WHO type 3 (recurrence or metastases)
- metastatic disease or locally recurrent disease not amendable curative therapy
- Patients must have measurable disease
- least one (not more than a total of three prior lines of chemotherapy for metastatic or recurrent disease). This must include at least 1 prior line of platinum-containing chemotherapy.
- An ECOG performance status of 0-2
Key exclusion criteria (15 listed)
- Patients who have not had at least 1 or more than 3 previous lines of treatment for metastatic or recurrent NPC
- Prior BORTEZOMIB therapy
- Immunotherapy ≤ 4 weeks have elapsed prior to study entry
- Biologic therapy ≤ 4 weeks have elapsed prior to study entry
- Radiation therapy ≤ 4 weeks have elapsed prior to study entry
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 |
|---|---|---|
| Velcadevelcade 1.3 mg/m2 given at the day 1,4,8,and 11 every 21 days schedule. | Drug | – |
Primary outcome
Efficacy based on response of measurable disease
Time frame: duration of study (4 -6 months)
3 secondary outcomes
EBV viral load
Time frame: duration of study (4 -6 months)
toxicities
Time frame: duration of study (4 -6 months)
molecular characterization of EBV in Plasma
Time frame: duration of study (4 -6 months)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
Related trials for Nasopharyngeal Carcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
Not yet recruitingObservational study
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
Nasopharyngeal Carcinoma (NPC)
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
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.
Wen-son Hsieh, M.D. study chair
Johns Hopkins Singapore-International Medical Center
Brigette Ma, M.D. study chair
Chinese University of Hong Kong
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Velcade in people with Nasopharyngeal Carcinoma, run by Johns Hopkins University at 3 sites in 2 countries.
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 17 inclusion and 15 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: withdrawn, as of the sponsor's last update on 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Singapore, China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Efficacy based on response of measurable disease (time frame: duration of study (4 -6 months)). 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 18 May 2020.