GliomaPhase 2NCT00165360
Prolonged Daily Temozolomide for Low-Grade Glioma
A Phase 2 study testing Temozolomide in people with Glioma and Astrocytoma, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The purpose of this trial is to determine the effects (good and bad) temozolomide has on patients with low-grade glioma. It will also determine whether temozolomide is effective in preventing or delaying future tumor growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Astrocytoma, Oligodendroglioma
- What is being tested?
- Temozolomide
- How many people
- 46 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2001to Sep 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological confirmation of a low-grade glioma (astrocytoma, oligodendroglioma, or mixed oligoastrocytoma)
- Measurable disease on MRI
- Patients that have undergone recent resection for newly diagnosed or recurrent or progressive tumor are eligible if they have recovered from the effects of surgery.
- Patients with recurrent disease my have had one prior chemotherapy regimen
- Older than 18 years of age.
- Karnofsky performance status (KPS) performance score of > 70%
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- Adequate hematologic, renal and liver functions,
- Life expectancy of greater than 12 weeks.
- Negative pregnancy test.
Who cannot join
- Prior treatment with temozolomide
- Patients who are not neurologically stable
- Acute infection treated with intravenous antibiotics
- Non-malignant systemic disease
- Frequent vomiting, inability to swallow or a medical condition that could interfere with oral medication.
- Previous or concurrent malignancies at other sites, with the exception of surgically cured carcinoma in-situ of the cervix, and basal or squamous cell carcinoma of the skin.
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- HIV positive or AIDS-related illness
- Pregnant or nursing women
- Patients with allergy to decarbazine.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase II Study of Prolonged Daily Temozolomide for Low-Grade Glioma
The purpose of this trial is to determine the effects (good and bad) temozolomide has on patients with low-grade glioma. It will also determine whether temozolomide is effective in preventing or delaying future tumor growth.
Read the detailed description
- Treatment with temozolomide is based upon an 11-week cycle (7 weeks on the drug and 4 weeks off). Patients will receive temozolomide once daily for 49 days, then have 28 days without taking temozolomide.
- Every two to four weeks a physical and neurological examination and blood work will be performed. A magnetic resonance imaging (MRI) scan of the patient's brain will be done approximately every three months (before each cycle of treatment).
- Treatment may continue for a maximum of a year and a half based on 6 eleven-week cycles. The actual duration of therapy will depend upon the response to treatment and the development of side effects or toxicity.
- Conditions
- Glioma, Astrocytoma, Oligodendroglioma
- Being tested
- Temozolomide
- Keywords
- low-grade glioma, astrocytoma, oligodendroglioma, oligoastrocytoma, temozolomide, mixed oligoastrocytoma
- Medical subject headings
- Glioma, Astrocytoma, Oligodendroglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideDrug
Given once daily for 49 days followed by 28 days with no drug for a maximum of a year and a half
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effects temozolomide has on low-grade gliomas
Measured: 3 years
Secondary outcomes (2)
To determine whether temozolomide is effective in preventing or delaying future tumor growth
Measured: 3 years
to determine the safety of temozolomide
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startSep 2001
- Primary completionDec 2006
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough, Brigham and Women's Hospital, University of Virginia
- Investigators
- Patrick Wen, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00165360
- Sponsor's protocol ID
- 01-111
- Status last verified
- Oct 2009
- First submitted
- 9 Sep 2005
- Last updated
- 2 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Prolonged Daily Temozolomide for Low-Grade Glioma
- ClinicalTrials.gov ID
- NCT00165360
- Acronym / sponsor ID
- 01-111
- Conditions
- Glioma, Astrocytoma, Oligodendroglioma
- Keywords
- low-grade glioma, astrocytoma, oligodendroglioma, oligoastrocytoma, temozolomide, mixed oligoastrocytoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Schering-Plough, Brigham and Women's Hospital, University of Virginia
- Study start
- Sep 2001
- Primary completion
- Dec 2006 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 14 Sep 2005 (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 trial is to determine the effects (good and bad) temozolomide has on patients with low-grade glioma. It will also determine whether temozolomide is effective in preventing or delaying future tumor growth.
Detailed description
- Treatment with temozolomide is based upon an 11-week cycle (7 weeks on the drug and 4 weeks off). Patients will receive temozolomide once daily for 49 days, then have 28 days without taking temozolomide.
- Every two to four weeks a physical and neurological examination and blood work will be performed. A magnetic resonance imaging (MRI) scan of the patient's brain will be done approximately every three months (before each cycle of treatment).
- Treatment may continue for a maximum of a year and a half based on 6 eleven-week cycles. The actual duration of therapy will depend upon the response to treatment and the development of side effects or toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histological confirmation of a low-grade glioma (astrocytoma, oligodendroglioma, or mixed oligoastrocytoma)
- Measurable disease on MRI
- Patients that have undergone recent resection for newly diagnosed or recurrent or progressive tumor are eligible if they have recovered from the effects of surgery.
- Patients with recurrent disease my have had one prior chemotherapy regimen
- Older than 18 years of age.
Key exclusion criteria (9 listed)
- Prior treatment with temozolomide
- Patients who are not neurologically stable
- Acute infection treated with intravenous antibiotics
- Non-malignant systemic disease
- Frequent vomiting, inability to swallow or a medical condition that could interfere with oral medication.
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 |
|---|---|---|
| TemozolomideGiven once daily for 49 days followed by 28 days with no drug for a maximum of a year and a half | Drug | – |
Primary outcome
To determine the effects temozolomide has on low-grade gliomas
Time frame: 3 years
2 secondary outcomes
To determine whether temozolomide is effective in preventing or delaying future tumor growth
Time frame: 3 years
to determine the safety of temozolomide
Time frame: 3 years
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 2 Nov 2009.
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EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
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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.
Patrick Wen, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Temozolomide in people with Glioma and Astrocytoma, run by Dana-Farber Cancer Institute at 2 sites 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 9 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 2 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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 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?
To determine the effects temozolomide has on low-grade gliomas (time frame: 3 years). 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 2 Nov 2009.