Non Small Cell Lung CancerPhase 1NCT00731952
Phase I Study of Induction Therapy With VELCADE and Vorinostat in Patients With Surgically Resectable Non-Small Cell Lung Cancer
A Phase 1 study testing Velcade and Vorinostat in people with Non Small Cell Lung Cancer, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of this study is to find out what effects (both good and bad) two medications (VELCADE and Vorinostat) have on patients who have certain types of lung cancer. The study is "dose escalating" meaning that patients will receive different doses of medication depending on when they enter the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Velcade and Vorinostat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Mar 2014
- 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 NSCLC (clinical stage IB, IIA, IIB, IIIA, or selected IIIB (T4N0-1M0)), exclusive of patients with MPE
- Planned surgical resection
- Age > 18 years
- ECOG performance status 0-1
- Patient has adequate organ and marrow function, as defined below:
- Patient has a platelet count of > 100 x 109/L
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- Patient has a WBC count of > 3.5 x 109/L
- Patient has an absolute neutrophil count of > 1.5 x 109/L
- Patient has hemoglobin of > 8 gm/dl. Patients may receive transfusions, erythropoietin or darbepoetin to achieve this hemoglobin level.
- Patient has a serum creatinine of < 2.0 mg/dL
- Patient has AST < 1.5 x ULN
- Patient has bilirubin < 1.5 x ULN
- Patient has INR < 1.5 x ULN
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
- Male subject agrees to use an acceptable method for contraception for the duration of the study
Who cannot join
- Previous chemotherapy or radiation therapy within 5 years before enrollment.
- Prior history of treatment for a known NSCLC within the last 5 years of if > 5 years but still thought by the investigator to represent recurrent disease.
- Prior exposure to either Velcade or Vorinostat
- Prior exposure to any HDAC inhibitors within the previous 30 days. Patients who have received such agents for other indications may enroll after 30-day wash-out period. Subject may not take any other HDAC inhibitor during this trial.
- Patient has >/= Grade 2 peripheral neuropathy within 14 days before enrollment.
- Myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or ECG evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
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- Patient has hypersensitivity to VELCADE, boron or mannitol.
- Patient has known allergy to any component of Vorinostat (MK-0683)
- Female subject is pregnant or breast-feeding. Confirm by a negative serum B-hCG pregnancy test result obtained during screening (not required for post-menopausal or surgically sterilized women).
- Patient is participating or has participated in another investigational trial, and has received other investigational drugs/therapies within 30 days of enrollment
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Patient has history of GI surgery or other procedures that might, in the opinion of the investigator, interfere with the absorption or swallowing of the study drugs.
- Subject is currently taking herbal remedy and/or homeopathic agent which cannot (or the patient is unwilling) be discontinued during the conduct of this trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
The purpose of this study is to find out what effects (both good and bad) two medications (VELCADE and Vorinostat) have on patients who have certain types of lung cancer. The study is "dose escalating" meaning that patients will receive different doses of medication depending on when they enter the study. Participation in the study will last approximately 3 months and will include an initial screening visit, a visit once each week for 3 weeks to receive the study medications, and then 2 additional visits around the time of your surgery to remove your lung cancer tumor.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Velcade and Vorinostat
- Keywords
- surgically resectable
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Velcade and VorinostatDrug
Subjects will receive one of 3 doses of Velcade (at a dose of 1.0 - 1.6 mg/m2 once weekly for 3 weeks) and one of 4 doses of Vorinostat (at a dose of 100mg every day 3 times a week for 3 weeks to 300mg twice per day, 3 times per week for 3 weeks). Doses determined by a predetermined escalation schedule.
| Study group | Role | What they receive |
|---|---|---|
| Velcade and Vorinostat | Experimental | Subjects will receive one of 3 doses of Velcade (at a dose of 1.0 - 1.6 mg/m2 once weekly for 3 weeks) and one of 4 doses of Vorinostat (at a dose of 100mg every day 3 times a week for 3 weeks to 300mg twice per day, 3 times per week for 3 weeks). Doses determined by a predetermined escalation schedule. Receives: Drug: Velcade and Vorinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: 30 days post surgical resection
Secondary outcomes (1)
Tumor response
Measured: Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startJun 2006
- Primary completionDec 2012
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Kozower, MD, University of Virginia
- Investigators
- David R Jones, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731952
- Sponsor's protocol ID
- 12472
- Status last verified
- May 2017
- First submitted
- 6 Aug 2008
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Induction Therapy With VELCADE and Vorinostat in Patients With Surgically Resectable Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00731952
- Acronym / sponsor ID
- 12472
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- surgically resectable
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 11 Aug 2008 (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 find out what effects (both good and bad) two medications (VELCADE and Vorinostat) have on patients who have certain types of lung cancer. The study is "dose escalating" meaning that patients will receive different doses of medication depending on when they enter the study. Participation in the study will last approximately 3 months and will include an initial screening visit, a visit once each week for 3 weeks to receive the study medications, and then 2 additional visits around the time of your surgery to remove your lung cancer tumor.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Velcade and Vorinostat | Experimental | Drug: Velcade and VorinostatSubjects will receive one of 3 doses of Velcade (at a dose of 1.0 - 1.6 mg/m2 once weekly for 3 weeks) and one of 4 doses of Vorinostat (at a dose of 100mg every day 3 times a week for 3 weeks to 300mg twice per day, 3 times per week for 3 weeks). Doses determined by a predetermined escalation schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically confirmed NSCLC (clinical stage IB, IIA, IIB, IIIA, or selected IIIB (T4N0-1M0)), exclusive of patients with MPE
- Planned surgical resection
- Age > 18 years
- ECOG performance status 0-1
- Patient has adequate organ and marrow function, as defined below:
Key exclusion criteria (13 listed)
- Previous chemotherapy or radiation therapy within 5 years before enrollment.
- Prior history of treatment for a known NSCLC within the last 5 years of if > 5 years but still thought by the investigator to represent recurrent disease.
- Prior exposure to either Velcade or Vorinostat
- Prior exposure to any HDAC inhibitors within the previous 30 days. Patients who have received such agents for other indications may enroll after 30-day wash-out period. Subject may not take any other HDAC inhibitor during this trial.
- Patient has >/= Grade 2 peripheral neuropathy within 14 days before enrollment.
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 and VorinostatSubjects will receive one of 3 doses of Velcade (at a dose of 1.0 - 1.6 mg/m2 once weekly for 3 weeks) and one of 4 doses of Vorinostat (at a dose of 100mg every day 3 times a week for 3 weeks to 300mg twice per day, 3 times per week for 3 weeks). Doses determined by a predetermined escalation schedule. | Drug | Velcade and Vorinostat |
Primary outcome
Adverse events
Time frame: 30 days post surgical resection
1 secondary outcome
Tumor response
Time frame: Day 22
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 4 May 2017.
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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.
David R Jones, MD principal investigator
University of Virginia
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 and Vorinostat in people with Non Small Cell Lung Cancer, run by University of Virginia 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 16 inclusion and 13 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 4 May 2017. 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?
Adverse events (time frame: 30 days post surgical resection). 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 4 May 2017.