CNS Tumor, AdultPhase 2NCT00313729
Temozolomide in Treating Patients With Low-Grade Glioma
A Phase 2 study testing temozolomide in people with CNS Tumor, Adult, run by University of California, San Francisco at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with supratentorial low-grade glioma. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- CNS Tumor, Adult
- What is being tested?
- temozolomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- May 1999to 12 Jun 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically proven supratentorial low-grade (grade II) glioma of any of the following histologic subtypes:
- Oligodendroglioma
- Astrocytoma
- Oligoastrocytoma
- Has undergone surgical resection or biopsy within 35 days after diagnosis of low-grade glioma
- Study treatment must begin between 14 days and 4 months after surgical resection or biopsy
- Evaluable disease by gadolinium-MRI
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 g/dL
- Creatinine < 1.5 times upper limit of normal (ULN)
- BUN < 1.5 times ULN
- Bilirubin < 1.5 times ULN
- SGOT < 2.5 times ULN
- Alkaline phosphatase < 2 times ULN
- Life expectancy > 12 weeks
- No nonmalignant systemic disease resulting in the patient being a poor medical risk
- No acute infection requiring intravenous antibiotics
- No frequent vomiting or medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction)
- No other concurrent malignancies except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin
- Prior malignancies must be in remission for ≥ 5 years
- No known HIV positivity
- No AIDS-related illness
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior radiotherapy, interstitial brachytherapy, or radiosurgery for low-grade glioma
- No prior biological therapy or chemotherapy for low-grade glioma
- No other concurrent chemotherapy
- No concurrent radiotherapy or biological therapy
- No concurrent prophylactic growth factors
- No concurrent epoetin alfa
- No other concurrent investigational drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
About this study
Official title: A Phase II Study of Temozolomide (TEMODAR) in the Treatment of Adult Patients With Supratentorial Low Grade Glioma
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with supratentorial low-grade glioma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the efficacy of temozolomide, defined as response rate (complete and partial response), in patients with supratentorial mixed low-grade glioma.
Secondary
- Assess the safety profile of temozolomide in patients with supratentorial low-grade glioma.
- Assess the time to tumor progression in patients treated with temozolomide.
OUTLINE: Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
- Conditions
- CNS Tumor, Adult
- Being tested
- temozolomide
- Keywords
- adult oligodendroglioma, adult mixed glioma, adult diffuse astrocytoma, adult pilocytic astrocytoma, adult pineal gland astrocytoma
- Medical subject headings
- Central Nervous System Neoplasms, Oligodendroglioma, Glioma, Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temozolomideDrug
Also called Temodar
Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Temozolomide | Experimental | Temozolomide Receives: Drug: temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate (Complete and Partial Response)
Assessment of treatment response was determined by MRI in conjunction with neurological examination and steroid requirement assessment derived from Macdonald's criteria. Complete response was defined as complete disappearance of lesion on consecutive MRI scans with stable or improved neuro exam and steroids. Partial response was defined as a 50% reduction in lesion size or that tumor burden was "definitely better" than prior scan with stable or improved neuro exam and steroids.
Measured: 12 months
Secondary outcomes (2)
Time to Tumor Progression
Progressive disease was defined as definite enlargement of any existing lesion or any new lesion based on modified Macdonald's criteria.
Measured: time from registration until date of the first documented progression, an average of 1 year
Safety Profile
Number of participants with treatment related grade 2-4 adverse events as defined by CTCAE 3.0
Measured: Time from registration up to 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2006 (estimated)
- Study startMay 1999
- Primary completion25 Sep 2014
- Study completion12 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CNS Tumor, AdultStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Chang, University of California, San Francisco
- Investigators
- Susan M. Chang, MD, Study chair, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00313729
- Sponsor's protocol ID
- CDR0000448883
- Other IDs
- 99102, BTRC-9902, H7858-16278-07
- Status last verified
- Jan 2019
- First submitted
- 11 Apr 2006
- Last updated
- 7 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Temozolomide (TEMODAR) in the Treatment of Adult Patients With Supratentorial Low Grade Glioma
- ClinicalTrials.gov ID
- NCT00313729
- Acronym / sponsor ID
- CDR0000448883
- Conditions
- CNS Tumor, Adult
- Keywords
- adult oligodendroglioma, adult mixed glioma, adult diffuse astrocytoma, adult pilocytic astrocytoma, adult pineal gland astrocytoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- May 1999
- Primary completion
- 25 Sep 2014 (actual)
- Study completion
- 12 Jun 2017 (actual)
- First posted
- 12 Apr 2006 (estimated)
- Results
- Posted 23 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with supratentorial low-grade glioma.
Detailed description
OBJECTIVES:
Primary
- Determine the efficacy of temozolomide, defined as response rate (complete and partial response), in patients with supratentorial mixed low-grade glioma.
Secondary
- Assess the safety profile of temozolomide in patients with supratentorial low-grade glioma.
- Assess the time to tumor progression in patients treated with temozolomide.
OUTLINE: Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temozolomide | Experimental | Drug: temozolomideTemozolomide |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| temozolomideAlso: TemodarChemotherapy | Drug | Temozolomide |
Primary outcome
Response Rate (Complete and Partial Response)
Time frame: 12 months
Assessment of treatment response was determined by MRI in conjunction with neurological examination and steroid requirement assessment derived from Macdonald's criteria. Complete response was defined as complete disappearance of lesion on consecutive MRI scans with stable or improved neuro exam and steroids. Partial response was defined as a 50% reduction in lesion size or that tumor burden was "definitely better" than prior scan with stable or improved neuro exam and steroids.
2 secondary outcomes
Time to Tumor Progression
Time frame: time from registration until date of the first documented progression, an average of 1 year
Safety Profile
Time frame: Time from registration up to 13 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Susan M. Chang, MD study chair
University of California, San Francisco
1 site 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 CNS Tumor, Adult, run by University of California, San Francisco 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?
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 7 Feb 2019. 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 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?
Yes. Results are posted in the registry (first posted 23 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Response Rate (Complete and Partial Response) (time frame: 12 months). 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 7 Feb 2019.