Central Nervous System TumorsPhase 2NCT00400816
Temozolomide in Treating Patients With Newly Diagnosed Anaplastic Oligodendroglioma or Mixed Oligoastrocytoma
A Phase 2 study testing temozolomide in people with Central Nervous System Tumors and Brain Tumor, run by The Cleveland Clinic 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Nervous System Tumors, Brain Tumor
- What is being tested?
- temozolomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to 6 Jan 2016
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed anaplastic oligodendroglioma or mixed oligoastrocytoma meeting 1 of the following criteria:
- Bidimensionally measurable disease
- Evaluable disease
- Nonevaluable disease as demonstrated by gross total surgical resection
- No immediate need for cranial irradiation
PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Life expectancy ≥ 12 weeks
- Absolute granulocyte count ≥ 1,500/mm³
- Hemoglobin ≥ 10.0 g/dL
- Platelet count ≥ 100,000/mm³
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ 2.0 times ULN
- AST ≤ 3.0 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No infection requiring systemic antibiotics within the past 14 days
- No other malignancy within the past 5 years except for carcinoma in situ of the cervix or nonmelanoma skin cancer
- No unrelated medical problems that would preclude study compliance
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy for this malignancy
- No prior radiotherapy to the brain
- No surgery requiring general anesthesia > 2 hours in duration within the past 10 days
- No prior temozolomide
- Concurrent steroids allowed provided dose is stable or decreasing for at least 1 week prior to study entry
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: Phase II Trial of Continuous Dose Temozolomide in Patients With Newly Diagnosed Pure and Mixed Anaplastic Oligodendroglioma
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 newly diagnosed anaplastic oligodendroglioma or mixed oligoastrocytoma.
Read the detailed description
OBJECTIVES:
- Determine progression-free survival of patients with newly diagnosed anaplastic oligodendroglioma (AO) or mixed oligoastrocytoma (MOA) treated with temozolomide.
- Determine the response rate in these patients.
- Assess the quality of life of patients with AO or MOA treated with this regimen.
OUTLINE: This is a parallel-group, multicenter study. Patients are stratified according to disease type (anaplastic oligodendroglioma vs mixed oligoastrocytoma).
Patients receive oral temozolomide once daily on days 1-7 and 15-21. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before courses 1, 3, 5, and 7, every 3 months for the first year after completion of treatment, every 4 months for the second year, every 6 months for the third and fourth years, and once a year thereafter.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
- Conditions
- Central Nervous System Tumors, Brain Tumor
- Being tested
- temozolomide
- Keywords
- adult anaplastic oligodendroglioma, adult mixed glioma
- Medical subject headings
- Central Nervous System Neoplasms, Brain Neoplasms, Oligodendroglioma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temozolomideDrug
Also called Temodar
Schedule of Temozolomide administration: Temozolomide, 150 mg/m2/d x days 1-7 and 15-21, given every 28 days [i.e., 7 days on/7 days off]
| Study group | Role | What they receive |
|---|---|---|
| Temozolomide | Experimental | Temozolomide, 150 mg/m2/d x days 1-7 and 15-21 Receives: Drug: temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
Time in months to patient's disease progresses
Measured: Survival of Last Patient
Secondary outcomes (1)
Toxicity--Count of Related Advers Events
Count of Treatment Related Toxicities
Measured: Post-Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2006 (estimated)
- Study startAug 2005
- Primary completion17 Jan 2008
- Study completion6 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David M. Peereboom, MD, Study chair, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400816
- Sponsor's protocol ID
- CASE-CCF-4204
- Other IDs
- P30CA043703
- Status last verified
- Jan 2018
- First submitted
- 16 Nov 2006
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Continuous Dose Temozolomide in Patients With Newly Diagnosed Pure and Mixed Anaplastic Oligodendroglioma
- ClinicalTrials.gov ID
- NCT00400816
- Acronym / sponsor ID
- CASE-CCF-4204
- Conditions
- Central Nervous System Tumors, Brain Tumor
- Keywords
- adult anaplastic oligodendroglioma, adult mixed glioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2005
- Primary completion
- 17 Jan 2008 (actual)
- Study completion
- 6 Jan 2016 (actual)
- First posted
- 17 Nov 2006 (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: 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 newly diagnosed anaplastic oligodendroglioma or mixed oligoastrocytoma.
Detailed description
OBJECTIVES:
- Determine progression-free survival of patients with newly diagnosed anaplastic oligodendroglioma (AO) or mixed oligoastrocytoma (MOA) treated with temozolomide.
- Determine the response rate in these patients.
- Assess the quality of life of patients with AO or MOA treated with this regimen.
OUTLINE: This is a parallel-group, multicenter study. Patients are stratified according to disease type (anaplastic oligodendroglioma vs mixed oligoastrocytoma).
Patients receive oral temozolomide once daily on days 1-7 and 15-21. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before courses 1, 3, 5, and 7, every 3 months for the first year after completion of treatment, every 4 months for the second year, every 6 months for the third and fourth years, and once a year thereafter.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 60 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, 150 mg/m2/d x days 1-7 and 15-21 |
Who may qualify
- Ages
- 18 years and older
- 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: TemodarSchedule of Temozolomide administration: Temozolomide, 150 mg/m2/d x days 1-7 and 15-21, given every 28 days [i.e., 7 days on/7 days off] | Drug | Temozolomide |
Primary outcome
Progression-Free Survival
Time frame: Survival of Last Patient
Time in months to patient's disease progresses
1 secondary outcome
Toxicity--Count of Related Advers Events
Time frame: Post-Treatment
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 Sep 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.
David M. Peereboom, MD study chair
Case Comprehensive 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 2 study testing temozolomide in people with Central Nervous System Tumors and Brain Tumor, run by The Cleveland Clinic 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 18 Sep 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 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?
Progression-Free Survival (time frame: Survival of Last Patient). 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 Sep 2018.