Brain Neoplasms, MalignantPhase 1NCT01151670
Pioglitazone Hydrochloride in Preventing Radiation-Induced Cognitive Dysfunction in Treating Patients With Brain Tumors
A Phase 1 study testing pioglitazone in people with Brain Neoplasms, Malignant and Brain Neoplasms, Benign, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
RATIONALE: Pioglitazone hydrochloride may be effective treatment for cognitive dysfunction caused by radiation therapy. PURPOSE: This phase I trial is studying the side effects and best dose of pioglitazone hydrochloride in preventing radiation-induced cognitive dysfunction in treating patients with brain tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Neoplasms, Malignant, Brain Neoplasms, Benign, Malignant Meningioma
- What is being tested?
- pioglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Aug 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
- Patients must have histologically or cytologically confirmed brain tumors of the following types: Group 1: malignant brain tumors (glioblastoma multiforme, anaplastic gliomas, brain metastases, and other malignant brain tumors); or Group 2: low grade brain tumors (low grade gliomas, meningiomas, and other low grade brain tumors)
- All stages and grades of brain tumors are eligible
- Patients must have an ECOG performance status of 0-2
- Patients must have agreed to be treated with fractionated, external beam radiation treatment (EBRT) with either curative or palliative intent (the length of the radiation course must at least be ten fractions)
- Patients must have agreed to have CT and MR imaging for purposes of radiation treatment planning, radiation treatment monitoring, and/or radiation treatment evaluation
- Patients must have measurable disease and/or relevant anatomic features using Magnetic Resonance Imaging
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- Prior therapies (cytotoxic, surgery, and radiation) are acceptable
- Use of steroids is acceptable when indicated
- Patients must be able to understand and willingly give informed written consent to participate
- Women of childbearing potential must not be pregnant or nursing and must use medically appropriate contraception if sexually active
- Patients must have a life expectancy of greater than 3 months
- Patients must be willing to comply with an oral treatment regimen and be able to swallow oral study tablets
Who cannot join
- History of allergic reactions to pioglitazone or any other member of the thiazolidinedione family
- Current diagnosis of diabetes as defined by fasting blood sugar > 125, treatment with anti-diabetic medications, or history of diabetes
- Patients who take insulin
- Patients who have NYHA class III or IV heart failure
- Patients who have elevated transaminases (AST or ALT > 2.5 times normal limit)
- Patients who have significantly impaired renal function (creatinine >= 1.5)
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- Patients who are significantly anemic (hematocrit < 33% in men, or < 30% in women)
- Patients who have symptomatic edema (>= grade 2)
- Patients who are on medications that have been shown to have a drug interaction with pioglitazone: atorvastatin (doses > 80 mg/day), systemic anti-fungals, medications with significant CYP 3A4 inhibiting properties
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac, arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study if their pregnancy precludes radiation treatment because ionizing radiation used in radiation treatment is an agent with known potential for teratogenic or abortifacient effects
- Patients with psychiatric or social illnesses that may impair compliance with the trial requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Use of Pioglitazone for the Prevention of Radiation-Induced Cognitive Dysfunction
RATIONALE: Pioglitazone hydrochloride may be effective treatment for cognitive dysfunction caused by radiation therapy.
PURPOSE: This phase I trial is studying the side effects and best dose of pioglitazone hydrochloride in preventing radiation-induced cognitive dysfunction in treating patients with brain tumors.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the tolerability and toxicity associated with two different dose regimens of pioglitazone administered orally as a cytoprotective agent against radiation-induced brain injury.
SECONDARY OBJECTIVE:
- To evaluate the effect of pioglitazone on glycemic levels and hemoglobin A1c values when pioglitazone is used as a cytoprotective agent concurrent with radiotherapy in normoglycemic patients.
OUTLINE: Patients undergo fractionated external beam radiotherapy, 3-D conformal radiotherapy, or intensity-modulated radiotherapy. Patients receive oral pioglitazone hydrochloride once daily before for 1 week prior to brain irradiation, during and and continuing for 6 months after completion of radiation radiotherapy. After completion of study treatment, patients are followed periodically.
- Conditions
- Brain Neoplasms, Malignant, Brain Neoplasms, Benign, Malignant Meningioma, Glioblastoma Multiforme, Anaplastic Astrocytoma
- Being tested
- pioglitazone
- Keywords
- radiation therapy, cognitive dysfunction, brain tumor, memory problems, short term memory loss
- Medical subject headings
- Brain Neoplasms, Meningioma, Glioblastoma, Astrocytoma, Cognitive Dysfunction, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pioglitazoneDrug
Also called Actos
Pioglitazone 22.5 mg daily before, during and after radiation therapy.
PioglitazoneDrug
Also called Actos
Pioglitazone 45 mg by mouth daily before, during and after radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Pioglitazone 22.5 mg once daily by mouth Receives: Drug: pioglitazone |
| Arm 2 | Experimental | Pioglitazone 45 mg once daily by mouth Receives: Drug: Pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best tolerated dose of 2 different doses of orally administered pioglitazone
Measured: From first dose to 1 day after last dose of drug
Secondary outcomes (2)
Toxicities associated with both dose levels
Measured: From first dose to 1 day after last dose of drug
To evaluate the effect of pioglitazone on glycemic levels and hemoglobin A1c values when pioglitazone is used as a cytoprotective agent concurrent with radiotherapy in normoglycemic patients.
Measured: From first dose to 1 day after last dose of drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Neoplasms, MalignantStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Chan, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151670
- Sponsor's protocol ID
- IRB00014528
- Other IDs
- NCI-2009-01452, CCCWFU 97409
- Status last verified
- Jul 2018
- First submitted
- 25 Jun 2010
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Pioglitazone for the Prevention of Radiation-Induced Cognitive Dysfunction
- ClinicalTrials.gov ID
- NCT01151670
- Acronym / sponsor ID
- IRB00014528
- Conditions
- Brain Neoplasms, Malignant, Brain Neoplasms, Benign, Malignant Meningioma, Glioblastoma Multiforme, Anaplastic Astrocytoma
- Keywords
- radiation therapy, cognitive dysfunction, brain tumor, memory problems, short term memory loss
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 28 Jun 2010 (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.
RATIONALE: Pioglitazone hydrochloride may be effective treatment for cognitive dysfunction caused by radiation therapy.
PURPOSE: This phase I trial is studying the side effects and best dose of pioglitazone hydrochloride in preventing radiation-induced cognitive dysfunction in treating patients with brain tumors.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the tolerability and toxicity associated with two different dose regimens of pioglitazone administered orally as a cytoprotective agent against radiation-induced brain injury.
SECONDARY OBJECTIVE:
- To evaluate the effect of pioglitazone on glycemic levels and hemoglobin A1c values when pioglitazone is used as a cytoprotective agent concurrent with radiotherapy in normoglycemic patients.
OUTLINE: Patients undergo fractionated external beam radiotherapy, 3-D conformal radiotherapy, or intensity-modulated radiotherapy. Patients receive oral pioglitazone hydrochloride once daily before for 1 week prior to brain irradiation, during and and continuing for 6 months after completion of radiation radiotherapy. After completion of study treatment, patients are followed periodically.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: pioglitazonePioglitazone 22.5 mg once daily by mouth |
| Arm 2 | Experimental | Drug: PioglitazonePioglitazone 45 mg once daily by mouth |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must have histologically or cytologically confirmed brain tumors of the following types: Group 1: malignant brain tumors (glioblastoma multiforme, anaplastic gliomas, brain metastases, and other malignant brain tumors); or Group 2: low grade brain tumors (low grade gliomas, meningiomas, and other low grade brain tumors)
- All stages and grades of brain tumors are eligible
- Patients must have an ECOG performance status of 0-2
- Patients must have agreed to be treated with fractionated, external beam radiation treatment (EBRT) with either curative or palliative intent (the length of the radiation course must at least be ten fractions)
- Patients must have agreed to have CT and MR imaging for purposes of radiation treatment planning, radiation treatment monitoring, and/or radiation treatment evaluation
Key exclusion criteria (12 listed)
- History of allergic reactions to pioglitazone or any other member of the thiazolidinedione family
- Current diagnosis of diabetes as defined by fasting blood sugar > 125, treatment with anti-diabetic medications, or history of diabetes
- Patients who take insulin
- Patients who have NYHA class III or IV heart failure
- Patients who have elevated transaminases (AST or ALT > 2.5 times normal limit)
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 |
|---|---|---|
| pioglitazoneAlso: ActosPioglitazone 22.5 mg daily before, during and after radiation therapy. | Drug | Arm I |
| PioglitazoneAlso: ActosPioglitazone 45 mg by mouth daily before, during and after radiation therapy | Drug | Arm 2 |
Primary outcome
Best tolerated dose of 2 different doses of orally administered pioglitazone
Time frame: From first dose to 1 day after last dose of drug
2 secondary outcomes
Toxicities associated with both dose levels
Time frame: From first dose to 1 day after last dose of drug
To evaluate the effect of pioglitazone on glycemic levels and hemoglobin A1c values when pioglitazone is used as a cytoprotective agent concurrent with radiotherapy in normoglycemic patients.
Time frame: From first dose to 1 day after last dose of drug
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 1 Aug 2018.
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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.
Michael Chan principal investigator
Wake Forest University Health Sciences
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 pioglitazone in people with Brain Neoplasms, Malignant and Brain Neoplasms, Benign, run by Wake Forest University Health Sciences 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 12 inclusion and 12 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 1 Aug 2018. 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?
Best tolerated dose of 2 different doses of orally administered pioglitazone (time frame: From first dose to 1 day after last dose of drug). 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 1 Aug 2018.