Advanced CancerPhase 1NCT00530907
Valproic Acid and Bevacizumab in Patients With Advanced Cancer
A Phase 1 study testing Valproic Acid and Bevacizumab in people with Advanced Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to find the highest tolerable dose of bevacizumab in combination with valproic acid that can be given to patients with advanced cancer that has not responded to standard treatment or where there is no standard treatment for the disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Valproic Acid and Bevacizumab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Nov 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with pathologically confirmed malignancy that is metastatic or unresectable and refractory to standard therapy or for whom there is no standard therapy that induces complete remission (CR) of at least 10% or an increased survival of at least 3 months.
- There is no maximum allowable number of prior chemotherapy regimens, provided all other eligibility criteria are met.
- ECOG performance status less than 2.
- Patients must have normal organ and marrow function as defined below: - absolute neutrophil count greater than or equal to 1,000/mcL - platelets greater than 50,000/mcL - total bilirubin less than 2 mg/dl - creatinine less than 2 mg/dl
- The effects of bevacizumab on the developing human fetus are unknown. For this reason and because valproic acid is known to be teratogenic, women of child-bearing potential and men who may impregnate a woman must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign an MD Anderson IRB approved written informed consent document.
- Both men and women of all races and ethnic groups are eligible for this trial.
Who cannot join
- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to receiving first dose of study drug or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.Patients may have received palliative radiation immediately before (or during) treatment provided radiation is not to the only target lesion available.
- Patients may not be receiving any other investigational agents for 28 days prior to first dose of drug on this study, and while pt is receiving this study drug.
- Patients whose brain mets or primary brain tumor includes symptoms that in the opinion of the principle investigator would either put the patients at unacceptable risk greater than the risk of the underlying cancer or if the treatment would unacceptably confound the analysis of the toxicity assessment.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab or valproic acid .
- Major surgery within the previous four weeks.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, HTN (with 2 or more antihypertensives), unstable angina pectoris or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because valproic acid is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with valproic acid and bevacizumab, breastfeeding should be discontinued if the mother is treated with these agents.
- Patient who are already on antiepileptic agents, for example; phenytoin, valproic acid, and neurontin will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of Valproic Acid Given in Combination With Bevacizumab in Patients With Advanced Cancer to Determine Safety and Tolerability
The goal of this clinical research study is to find the highest tolerable dose of bevacizumab in combination with valproic acid that can be given to patients with advanced cancer that has not responded to standard treatment or where there is no standard treatment for the disease. The safety of this drug combination will also be studied.
Read the detailed description
Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels. Valproic acid works the same was way as bevacizumab and is also used in the treatment of seizures, migraine headaches, and mood disturbances in bipolar disorders.
If you are found to be eligible to take part in this study, you will receive the study drugs as an outpatient. You will receive bevacizumab by vein over 90 minutes (for the first infusion) once every 2 weeks. Once the study doctor determines that you are able to tolerate the drug, it will be given over 60 minutes for the second infusion and then over 30 minutes for further infusions. Valproic acid will be given by mouth (capsule(s)) each day for 28 days. You will take valproic acid once or twice a day depending on your dose. Every 28 days is considered 1 cycle.
You will have blood drawn (about 2 teaspoons) and urine collected for routine tests every cycle, about every 1-2 weeks, so that researchers can monitor the safety of the study drugs. Once every 8 weeks you will have tumor markers tested as part of the routine blood draw. You will have a physical exam once a cycle.
You will have either a CT or MRI scan of the tumor about every 8 weeks to check the status (whether it is growing or shrinking) of the cancer. If your doctor thinks other tests are necessary he/she will discuss those with you.
You will continue to receive bevacizumab and valproic acid as long as the disease is considered stable. You will receive up to 12 cycles of the study drug. If the disease gets worse or you experience any intolerable side effects, you will be taken off this study.
You will have an end-of-study visit 28 days after your last dose of bevacizumab. At this visit, you will have a complete physical exam, including measurement of your vital signs and blood pressure. You will have a neurological exam, and blood (about 2 teaspoons) will be drawn for routine and tumor marker tests. You will be asked about any medications you may be taking and whether you have had any side effects. You will also be asked how well you are able to perform daily activities.
This is an investigational study. Bevacizumab and valproic acid are both FDA approved and commercially available. Their use together in this study is investigational and authorized for use in research only. Up to 80 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Advanced Cancer
- Being tested
- Valproic Acid, Bevacizumab
- Keywords
- Advanced Cancer, Valproic Acid, Depakene, Bevacizumab, Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valproic AcidDrug
Also called Depakene
5.3 mg/kg by mouth daily x 28 days
BevacizumabDrug
Also called Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF
2.5 mg/kg by vein over 90 minutes every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Valproic Acid + Bevacizumab | Experimental | Valproic acid administered at a dose of 5.3 mg/Kg/day on days 1 - 28. Depending on the calculated dose, patients will take capsules once or twice a day per mouth.
Bevacizumab administered at a dose of 2.5 mg/kg by vein every 2 weeks. Receives: Drug: Valproic Acid; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Highest tolerable dose of bevacizumab in combination with valproic acid
Measured: 28 day cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2007 (estimated)
- Study startJun 2007
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Wheler, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530907
- Sponsor's protocol ID
- 2005-0676
- Status last verified
- Nov 2013
- First submitted
- 14 Sep 2007
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Valproic Acid Given in Combination With Bevacizumab in Patients With Advanced Cancer to Determine Safety and Tolerability
- ClinicalTrials.gov ID
- NCT00530907
- Acronym / sponsor ID
- 2005-0676
- Conditions
- Advanced Cancer
- Keywords
- Advanced Cancer, Valproic Acid, Depakene, Bevacizumab, Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 18 Sep 2007 (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 goal of this clinical research study is to find the highest tolerable dose of bevacizumab in combination with valproic acid that can be given to patients with advanced cancer that has not responded to standard treatment or where there is no standard treatment for the disease. The safety of this drug combination will also be studied.
Detailed description
Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels. Valproic acid works the same was way as bevacizumab and is also used in the treatment of seizures, migraine headaches, and mood disturbances in bipolar disorders.
If you are found to be eligible to take part in this study, you will receive the study drugs as an outpatient. You will receive bevacizumab by vein over 90 minutes (for the first infusion) once every 2 weeks. Once the study doctor determines that you are able to tolerate the drug, it will be given over 60 minutes for the second infusion and then over 30 minutes for further infusions. Valproic acid will be given by mouth (capsule(s)) each day for 28 days. You will take valproic acid once or twice a day depending on your dose. Every 28 days is considered 1 cycle.
You will have blood drawn (about 2 teaspoons) and urine collected for routine tests every cycle, about every 1-2 weeks, so that researchers can monitor the safety of the study drugs. Once every 8 weeks you will have tumor markers tested as part of the routine blood draw. You will have a physical exam once a cycle.
You will have either a CT or MRI scan of the tumor about every 8 weeks to check the status (whether it is growing or shrinking) of the cancer. If your doctor thinks other tests are necessary he/she will discuss those with you.
You will continue to receive bevacizumab and valproic acid as long as the disease is considered stable. You will receive up to 12 cycles of the study drug. If the disease gets worse or you experience any intolerable side effects, you will be taken off this study.
You will have an end-of-study visit 28 days after your last dose of bevacizumab. At this visit, you will have a complete physical exam, including measurement of your vital signs and blood pressure. You will have a neurological exam, and blood (about 2 teaspoons) will be drawn for routine and tumor marker tests. You will be asked about any medications you may be taking and whether you have had any side effects. You will also be asked how well you are able to perform daily activities.
This is an investigational study. Bevacizumab and valproic acid are both FDA approved and commercially available. Their use together in this study is investigational and authorized for use in research only. Up to 80 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Valproic Acid + Bevacizumab | Experimental | Drug: Valproic Acid, Drug: BevacizumabValproic acid administered at a dose of 5.3 mg/Kg/day on days 1 - 28. Depending on the calculated dose, patients will take capsules once or twice a day per mouth. Bevacizumab administered at a dose of 2.5 mg/kg by vein every 2 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with pathologically confirmed malignancy that is metastatic or unresectable and refractory to standard therapy or for whom there is no standard therapy that induces complete remission (CR) of at least 10% or an increased survival of at least 3 months.
- There is no maximum allowable number of prior chemotherapy regimens, provided all other eligibility criteria are met.
- ECOG performance status less than 2.
- Patients must have normal organ and marrow function as defined below: - absolute neutrophil count greater than or equal to 1,000/mcL - platelets greater than 50,000/mcL - total bilirubin less than 2 mg/dl - creatinine less than 2 mg/dl
- The effects of bevacizumab on the developing human fetus are unknown. For this reason and because valproic acid is known to be teratogenic, women of child-bearing potential and men who may impregnate a woman must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Key exclusion criteria (8 listed)
- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to receiving first dose of study drug or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.Patients may have received palliative radiation immediately before (or during) treatment provided radiation is not to the only target lesion available.
- Patients may not be receiving any other investigational agents for 28 days prior to first dose of drug on this study, and while pt is receiving this study drug.
- Patients whose brain mets or primary brain tumor includes symptoms that in the opinion of the principle investigator would either put the patients at unacceptable risk greater than the risk of the underlying cancer or if the treatment would unacceptably confound the analysis of the toxicity assessment.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab or valproic acid .
- Major surgery within the previous four weeks.
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 |
|---|---|---|
| Valproic AcidAlso: Depakene5.3 mg/kg by mouth daily x 28 days | Drug | Valproic Acid + Bevacizumab |
| BevacizumabAlso: Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF2.5 mg/kg by vein over 90 minutes every 2 weeks | Drug | Valproic Acid + Bevacizumab |
Primary outcome
Highest tolerable dose of bevacizumab in combination with valproic acid
Time frame: 28 day cycle
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 8 Jan 2015.
- The University of Texas M.D.Anderson Cancer CenterLink 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.
Jennifer Wheler, MD principal investigator
M.D. Anderson Cancer Center
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 Valproic Acid and Bevacizumab in people with Advanced Cancer, run by M.D. Anderson Cancer Center 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 7 inclusion and 8 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 8 Jan 2015. 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?
Highest tolerable dose of bevacizumab in combination with valproic acid (time frame: 28 day cycle). 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 8 Jan 2015.