Lung CancerPhase 1NCT00996060
Use of Hydralazine and Valproic Acid in Advanced Solid Tumor Malignancies
A Phase 1 study testing Hydralazine and Valproic Acid: Cohort -1, Hydralazine and Valproic Acid: Cohort 0 and Hydralazine and Valproic Acid: Cohort 1 in people with Lung Cancer, run by New Mexico Cancer Research Alliance at 1 site in United States.
Trial summary
1. Primary Objective: The primary endpoint to this study will be to document the toxicities, and reversibility of toxicities, of this regimen of hydralazine and valproic acid in patients with advanced, unresectable, previously treated lung cancers, for whom no acceptable standard therapy is available. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Hydralazine and Valproic Acid: Cohort -1, Hydralazine and Valproic Acid: Cohort 0 and Hydralazine and Valproic Acid: Cohort 1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with lung cancer who have disease which has been previously treated and/or for which there is no acceptable standard treatment regimen available, and cannot be treated definitively with either surgery or radiotherapy.
- All will be appropriate candidates for treatment, and are not candidates for treatment with protocols of higher priority.
- All patients should have an ECOG/Zubrod/SWOG performance status of less than 2 at the time of the initiation of therapy
- Adequate end-organ function
- No severe comorbid disease
- Ability to provide informed consent.
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- Signed Informed Consent
- ECOG/Zubrod/SWOG Performance Status less than 2
- Life expectancy greater than 8 weeks
- Male or female' age greater than 18 years
- Patients of childbearing potential must be using an effective means of contraception.
- Histologic diagnosis of lung cancer that is advanced and cannot be treated adequately by radiotherapy or surgery; or metastatic disease, and for which there is no standard chemotherapeutic option remaining or available
- All participants must have either previously received or refused standard chemotherapy
- Baseline laboratory values (bone marrow, renal, hepatic):
- Adequate bone marrow function:
- Absolute neutrophil count greater than 1000/µL
- Platelet count greater than 100'000/µL
- Renal function:
- Serum creatinine less than 2.0 mg %
- Hepatic function:
- Bilirubin less than 1.5x normal
- Serum calcium less than 12 mg/dl
Who cannot join
- Pregnant or lactating females
- Myocardial infarction or ischemia within the 6 months before Cycle 0' Day 0
- Uncontrolled' clinically significant dysrhythmia
- Prior radiotherapy to an indicator lesion unless there is objective evidence of tumor growth in that lesion
- Prior autoimmune disease
- Uncontrolled metastatic disease of the central nervous system
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- Radiotherapy within the 2 weeks before Cycle 1' Day -14
- Surgery within the 2 weeks before Cycle 1' Day -14
- Any co morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
About this study
Official title: A Phase 1 Protocol of Hydralazine and Valproic Acid in Advanced Solid Tumor Malignancies
- Primary Objective: The primary endpoint to this study will be to document the toxicities, and reversibility of toxicities, of this regimen of hydralazine and valproic acid in patients with advanced, unresectable, previously treated lung cancers, for whom no acceptable standard therapy is available. A primary endpoint will be to determine any potential dose limiting toxicities, and the Maximal Tolerated Dose of this regimen.
- Secondary Objectives:
The secondary endpoint of this study will be to determine any potential anti-tumor effects, as determined by the objective tumor response (complete and partial responses), clinical benefit (complete and partial responses, and clinical benefit), the time to tumor response, the time to tumor progression, and the overall survival.
Read the detailed description
This study will be an open-label, non-randomized, dose-escalation phase I trial which will enroll in sequential cohorts.
- Conditions
- Lung Cancer
- Being tested
- Hydralazine and Valproic Acid: Cohort -1, Hydralazine and Valproic Acid: Cohort 0, Hydralazine and Valproic Acid: Cohort 1, Hydralazine and Valproic Acid: Cohort 2, Hydralazine and Valproic Acid: Cohort 3
- Keywords
- Lung Cancer, Advanced Lung Cancer, Unresectable Lung cancer, Previously treated lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydralazine and Valproic Acid: Cohort -1Drug
Also called Depakote (Valproic Acid), Apresoline (Hydralazine)
Initially, 3 patients will be enrolled into each cohort, beginning with the hydralazine 25 mg PO daily, with the valproic acid dosing beginning two weeks earlier to achieve a steady state level of valproic acid in the blood.
In this cohort, Hydralazine is administered at 10 mg/day.
Hydralazine and Valproic Acid: Cohort 0Drug
Also called Depakote (Valproic Acid), Apresoline (Hydralazine)
Initially, 3 patients will be enrolled into each cohort, beginning with the hydralazine 25 mg PO daily, with the valproic acid dosing beginning two weeks earlier to achieve a steady state level of valproic acid in the blood.
Hydralazine is administered at 25 mg/day in this cohort.
Hydralazine and Valproic Acid: Cohort 1Drug
Also called Depakote (Valproic Acid), Apresoline (Hydralazine)
Initially, 3 patients will be enrolled into each cohort, beginning with the hydralazine 25 mg PO daily, with the valproic acid dosing beginning two weeks earlier to achieve a steady state level of valproic acid in the blood.
Hydralazine is administered at 50 mg/day in this cohort.
Hydralazine and Valproic Acid: Cohort 2Drug
Also called Depakote (Valproic Acid), Apresoline (Hydralazine)
Initially, 3 patients will be enrolled into each cohort, beginning with the hydralazine 25 mg PO daily, with the valproic acid dosing beginning two weeks earlier to achieve a steady state level of valproic acid in the blood.
Hydralazine is administered at 100 mg/day in this cohort as 25 mg four times per day.
Hydralazine and Valproic Acid: Cohort 3Drug
Also called Depakote (Valproic Acid), Apresoline (Hydralazine)
Initially, 3 patients will be enrolled into each cohort, beginning with the hydralazine 25 mg PO daily, with the valproic acid dosing beginning two weeks earlier to achieve a steady state level of valproic acid in the blood.
Hydralazine is administered at 200 mg/day in this cohort as 50 mg four times per day.
Hydralazine and Valproic Acid: Cohort 4Drug
Also called Apresoline (Hydralazine), Depakote (Valproic Acid)
Initially, 3 patients will be enrolled into each cohort, beginning with the hydralazine 25 mg PO daily, with the valproic acid dosing beginning two weeks earlier to achieve a steady state level of valproic acid in the blood.
Hydralazine is administered at 300 mg/day in this cohort as 75 mg four times per day.
Hydralazine and Valproic Acid: Cohort 5Drug
Also called Apresoline (Hydralazine), Depakote (Valproic Acid)
Initially, 3 patients will be enrolled into each cohort, beginning with the hydralazine 25 mg PO daily, with the valproic acid dosing beginning two weeks earlier to achieve a steady state level of valproic acid in the blood.
Hydralazine is administered at 400 mg/day in this cohort as 100 mg four times per day.
| Study group | Role | What they receive |
|---|---|---|
| Hydralazine and Valproic Acid | Experimental | Starting dose of Hydralazine is 25 mg orally daily, days 1-28. (See Intervention for Dose Escalation Schema) Valproic acid 250 mg orally three times per day for days -14 through -8, then 500 mg orally three times per day daily for days -7 through 28, with the dose titrated to keep the serum level between 0.4 and 0.7 mM. Receives: Drug: Hydralazine and Valproic Acid: Cohort -1; Drug: Hydralazine and Valproic Acid: Cohort 0; Drug: Hydralazine and Valproic Acid: Cohort 1; Drug: Hydralazine and Valproic Acid: Cohort 2; Drug: Hydralazine and Valproic Acid: Cohort 3; Drug: Hydralazine and Valproic Acid: Cohort 4; Drug: Hydralazine and Valproic Acid: Cohort 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
A primary endpoint will be to determine any potential dose limiting toxicities, & the Maximal Tolerated Dose of hydralazine & valproic acid regimen.
Measured: 28 days
Secondary outcomes (1)
To determine any potential anti-tumor effects, as determined by the objective tumor response, clinical benefit, the time to tumor response, the time to tumor progression, and the overall survival.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startJul 2008
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Mexico Cancer Research Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monte Shaheen, M.D., Principal investigator, University of New Mexico Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996060
- Sponsor's protocol ID
- INST 0712C
- Other IDs
- NCI-2011-02651
- Status last verified
- Jan 2016
- First submitted
- 26 Mar 2009
- Last updated
- 18 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Protocol of Hydralazine and Valproic Acid in Advanced Solid Tumor Malignancies
- ClinicalTrials.gov ID
- NCT00996060
- Acronym / sponsor ID
- INST 0712C
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, Advanced Lung Cancer, Unresectable Lung cancer, Previously treated lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- New Mexico Cancer Research AllianceUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 16 Oct 2009 (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.
- Primary Objective: The primary endpoint to this study will be to document the toxicities, and reversibility of toxicities, of this regimen of hydralazine and valproic acid in patients with advanced, unresectable, previously treated lung cancers, for whom no acceptable standard therapy is available. A primary endpoint will be to determine any potential dose limiting toxicities, and the Maximal Tolerated Dose of this regimen.
- Secondary Objectives:
The secondary endpoint of this study will be to determine any potential anti-tumor effects, as determined by the objective tumor response (complete and partial responses), clinical benefit (complete and partial responses, and clinical benefit), the time to tumor response, the time to tumor progression, and the overall survival.
Detailed description
This study will be an open-label, non-randomized, dose-escalation phase I trial which will enroll in sequential cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydralazine and Valproic Acid | Experimental | Drug: Hydralazine and Valproic Acid: Cohort -1, Drug: Hydralazine and Valproic Acid: Cohort 0, Drug: Hydralazine and Valproic Acid: Cohort 1, Drug: Hydralazine and Valproic Acid: Cohort 2, Drug: Hydralazine and Valproic Acid: Cohort 3, Drug: Hydralazine and Valproic Acid: Cohort 4, Drug: Hydralazine and Valproic Acid: Cohort 5Starting dose of Hydralazine is 25 mg orally daily, days 1-28. (See Intervention for Dose Escalation Schema) Valproic acid 250 mg orally three times per day for days -14 through -8, then 500 mg orally three times per day daily for days -7 through 28, with the dose titrated to keep the serum level between 0.4 and 0.7 mM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- All patients with lung cancer who have disease which has been previously treated and/or for which there is no acceptable standard treatment regimen available, and cannot be treated definitively with either surgery or radiotherapy.
- All will be appropriate candidates for treatment, and are not candidates for treatment with protocols of higher priority.
- All patients should have an ECOG/Zubrod/SWOG performance status of less than 2 at the time of the initiation of therapy
- Adequate end-organ function
- No severe comorbid disease
Key exclusion criteria (9 listed)
- Pregnant or lactating females
- Myocardial infarction or ischemia within the 6 months before Cycle 0' Day 0
- Uncontrolled' clinically significant dysrhythmia
- Prior radiotherapy to an indicator lesion unless there is objective evidence of tumor growth in that lesion
- Prior autoimmune disease
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 |
|---|---|---|
| Hydralazine and Valproic Acid: Cohort -1Also: Depakote (Valproic Acid), Apresoline (Hydralazine)Initially, 3 patients will be enrolled into each cohort, beginning with the hydralazine 25 mg PO daily, with the valproic acid dosing beginning two weeks earlier to achieve a steady state level of valproic acid in the blood. In this cohort, Hydralazine is administered at 10 mg/day. | Drug | Hydralazine and Valproic Acid |
| Hydralazine and Valproic Acid: Cohort 0Also: Depakote (Valproic Acid), Apresoline (Hydralazine)Initially, 3 patients will be enrolled into each cohort, beginning with the hydralazine 25 mg PO daily, with the valproic acid dosing beginning two weeks earlier to achieve a steady state level of valproic acid in the blood. Hydralazine is administered at 25 mg/day in this cohort. | Drug | Hydralazine and Valproic Acid |
| Hydralazine and Valproic Acid: Cohort 1Also: Depakote (Valproic Acid), Apresoline (Hydralazine)Initially, 3 patients will be enrolled into each cohort, beginning with the hydralazine 25 mg PO daily, with the valproic acid dosing beginning two weeks earlier to achieve a steady state level of valproic acid in the blood. Hydralazine is administered at 50 mg/day in this cohort. | Drug | Hydralazine and Valproic Acid |
| Hydralazine and Valproic Acid: Cohort 2Also: Depakote (Valproic Acid), Apresoline (Hydralazine)Initially, 3 patients will be enrolled into each cohort, beginning with the hydralazine 25 mg PO daily, with the valproic acid dosing beginning two weeks earlier to achieve a steady state level of valproic acid in the blood. Hydralazine is administered at 100 mg/day in this cohort as 25 mg four times per day. | Drug | Hydralazine and Valproic Acid |
| Hydralazine and Valproic Acid: Cohort 3Also: Depakote (Valproic Acid), Apresoline (Hydralazine)Initially, 3 patients will be enrolled into each cohort, beginning with the hydralazine 25 mg PO daily, with the valproic acid dosing beginning two weeks earlier to achieve a steady state level of valproic acid in the blood. Hydralazine is administered at 200 mg/day in this cohort as 50 mg four times per day. | Drug | Hydralazine and Valproic Acid |
| Hydralazine and Valproic Acid: Cohort 4Also: Apresoline (Hydralazine), Depakote (Valproic Acid)Initially, 3 patients will be enrolled into each cohort, beginning with the hydralazine 25 mg PO daily, with the valproic acid dosing beginning two weeks earlier to achieve a steady state level of valproic acid in the blood. Hydralazine is administered at 300 mg/day in this cohort as 75 mg four times per day. | Drug | Hydralazine and Valproic Acid |
| Hydralazine and Valproic Acid: Cohort 5Also: Apresoline (Hydralazine), Depakote (Valproic Acid)Initially, 3 patients will be enrolled into each cohort, beginning with the hydralazine 25 mg PO daily, with the valproic acid dosing beginning two weeks earlier to achieve a steady state level of valproic acid in the blood. Hydralazine is administered at 400 mg/day in this cohort as 100 mg four times per day. | Drug | Hydralazine and Valproic Acid |
Primary outcome
A primary endpoint will be to determine any potential dose limiting toxicities, & the Maximal Tolerated Dose of hydralazine & valproic acid regimen.
Time frame: 28 days
1 secondary outcome
To determine any potential anti-tumor effects, as determined by the objective tumor response, clinical benefit, the time to tumor response, the time to tumor progression, and the overall survival.
Time frame: 28 days
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 18 Jan 2016.
- University of New Mexico Cancer CenterLink provided by the sponsor.
- New Mexico Cancer Care AllianceLink 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.
Monte Shaheen, M.D. principal investigator
University of New Mexico 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 Hydralazine and Valproic Acid: Cohort -1, Hydralazine and Valproic Acid: Cohort 0 and Hydralazine and Valproic Acid: Cohort 1 in people with Lung Cancer, run by New Mexico Cancer Research Alliance 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 22 inclusion and 9 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 18 Jan 2016. 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?
A primary endpoint will be to determine any potential dose limiting toxicities, & the Maximal Tolerated Dose of hydralazine & valproic acid regimen. (time frame: 28 days). 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 Jan 2016.