GlioblastomaPhase 2NCT00365222
Phase II Study of Temozolomide in Newly Diagnosed Glioblastoma
A Phase 2 study testing Temozolomide in people with Glioblastoma and Gliosarcoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
A single arm Phase 2 trial with the study drug temozolomide (temodar) for newly diagnosed glioblastoma in elderly patients (defined as greater than or equal to 70 years old). Following surgical resection, and confirmation of glioblastoma, patients will proceed to primary chemotherapy with temozolomide (temodar). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Glioblastoma, Gliosarcoma
- What is being tested?
- Temozolomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jun 2007
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients must have histological documented glioblastoma or gliosarcoma. All patients must have had prior pathologic confirmation of tumor histology.
- Patients must be > than or equal to 70 years old.
- Patients must have a Karnofsky performance status of > 50.
- Nonmeasurable disease or measurable disease per MacDonald criteria
- Patients must have a predicted life expectancy of at least 12 weeks.
- Required initial laboratory data: ANC >1,500, Platelets >100,000, Serum Creatinine <2.0, Serum Bilirubin <2.0, and AST/ALT <3x normal
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- Patients must sign and date an IRB approved informed consent form stating he or she is aware of the neoplastic nature of the disease. Patient must willingly provide written consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts. (Human protection committee approval of this protocol and consent form is required).
- Patients must be willing and able to comply with scheduled visits, treatment plan, and laboratory tests and accessible for follow-up.
- Patients must have been previously treated with surgery.
- No prior adjuvant or salvage chemotherapy regimen is permitted.
- Prior radiotherapy is not permitted.
Who cannot join
- Patients have evidence of leptomeningeal spread of disease.
- Patients having been treated with prior chemotherapy or radiotherapy.
- Patients with a second active malignancy or diagnosis of other cancer within -3 years of enrollment, except for surgically cured basal cell carcinoma, or in situ carcinoma of the cervix.
- Mentally incapacitated patients or psychiatric illness that would prevent the patient from giving informed consent.
- Patients with poorly controlled diabetes, hepatitis infection, uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, and myocardial infarction within the previous six months, or serious uncontrolled cardiac arrhythmia.
- Known to be HIV positive or to have an AIDS-related illness.
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- Patients with an active infection that is not adequately controlled with antibiotics.
- Patients with other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- Patients with a known sensitivity to any of the products to be administered during treatment.
- Patients currently enrolled in another clinical trial or patients who have participated in a trial of an investigational device or drug within the last 30 days.
- Patients previously treated with temozolomide.
- Concurrent radiotherapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
About this study
Official title: Phase II Study of Dose Intensive Temozolomide in Elderly Adults With Newly Diagnosed Glioblastoma
A single arm Phase 2 trial with the study drug temozolomide (temodar) for newly diagnosed glioblastoma in elderly patients (defined as greater than or equal to 70 years old). Following surgical resection, and confirmation of glioblastoma, patients will proceed to primary chemotherapy with temozolomide (temodar). Temodar is given for 42 consecutive days on and 14 days off occurring every 56 days.
Procedures prior to initial study treatment (<14 Days) are: Neurological/Oncological History, Neurological Examination, Height, Weight, and Body Surface Area, Performance Status, Quality Of Life FACT-BR, Labs, MGMT tissue analysis, and Cranial CT/MRI with and without contrast.
Read more
The same procedures are repeated on Day 1 of each treatment cycle with the addition of an adverse event assessment. And the off study procedures for patients are performance status, Quality Of Life FACT-BR, MGMT tissue analysis, and cranial CT/MRI with and without contrast.
Patients may continue with each temodar daily dose therapy if clinical and neuroradiographical exams are stable or improving.
Read the detailed description
A single arm Phase 2 trial with the study drug temozolomide (temodar) for newly diagnosed glioblastoma in elderly patients (defined as greater than or equal to 70 years old). Temozolomide will be administered orally (a capsule) at approximately the same time daily (bedtime) for 42 days on and then 14 days off; cycles may be repeated every 56 days. Complete blood counts will be obtained bi-weekly, evaluations monthly and MRI's every 2 months after a cycle of therapy.
Procedures prior to initial study treatment (<14 Days) are: Neurological/Oncological History, Neurological Examination, Height, Weight, and Body Surface Area, Performance Status, Quality Of Life FACT-BR, Labs, MGMT tissue analysis, and Cranial CT/MRI with and without contrast (all disease found at staging must be followed using the same modality used at Pre-treatment. Tumor assessments are to be repeated every 56 days thereafter until progression). The same procedures are repeated on Day 1 of each treatment cycle with the addition of an adverse event assessment.
Patients may continue on therapy unless one of the following occurs:
- Documented or clinical progressive disease at any time
- Unacceptable toxicity
- Treatment delay of > 2 weeks for any reason
- Study data or other data indicate that the study treatment is not beneficial for the patients; defined as at least one response in the first 12 patients within each tumor histology strata
- Non-compliance by the patient with protocol requirements (follow-up, treatment, administration of disallowed therapy)
- Changes in medical status of the patient such that the patient no longer meets eligibility requirements (leptomeningeal spread, change in mental competency) or the investigator believes that patient safety will be compromised.
- Patient withdrawal of consent for treatment
- Occurrence of one toxic death
Patients with CR, PR, or stable disease (SD) will be treated for a minimum of 3 cycles [6 months] or until disease progression. For patients responding to treatment, continuation of therapy beyond 3 cycles is at the discretion of the investigator. Response parameters will include the MacDonald criteria for evaluating brain tumors. Response is measured by a reduction in tumor size.
After cessation of protocol therapy, patients will continue to be followed for survival at 2-month intervals for up to three years from start of treatment. And the off study procedures for patients are performance status, Quality Of Life FACT-BR, MGMT tissue analysis, and cranial CT/MRI with and without contrast.
- Conditions
- Glioblastoma, Gliosarcoma
- Being tested
- Temozolomide
- Keywords
- Temozolomide, Temodar, Glioblastoma, Gliosarcoma, Brain Tumor, Quality of Life, Neurological
- Medical subject headings
- Glioblastoma, Gliosarcoma, Brain Neoplasms, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideDrug
Also called Temodar
temozolomide 75 mg/m2 /d
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate overall survival
Measured: dependent upon results
Secondary outcomes (4)
Progression-free survival at six and nine months
Measured: 9 months
Response rate measured by a reduction in tumor size
Measured: 9 months
Frequency and severity of adverse events
Measured: 9 months
Quality of life measured at each cycle utilizing the QOL FACT-BR
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionJun 2007
- Study completionJun 2007
Why it stopped: IRB Study Closure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research 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
- 1 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough
- Investigators
- Marc Chamberlain, MD, Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365222
- Sponsor's protocol ID
- MCC-14714
- Status last verified
- Jan 2009
- First submitted
- 15 Aug 2006
- Last updated
- 22 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Dose Intensive Temozolomide in Elderly Adults With Newly Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT00365222
- Acronym / sponsor ID
- MCC-14714
- Conditions
- Glioblastoma, Gliosarcoma
- Keywords
- Temozolomide, Temodar, Glioblastoma, Gliosarcoma, Brain Tumor, Quality of Life, Neurological
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IRB Study Closure
- Enrolment
- 1 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Schering-Plough
- Study start
- Jul 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 17 Aug 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.
A single arm Phase 2 trial with the study drug temozolomide (temodar) for newly diagnosed glioblastoma in elderly patients (defined as greater than or equal to 70 years old). Following surgical resection, and confirmation of glioblastoma, patients will proceed to primary chemotherapy with temozolomide (temodar). Temodar is given for 42 consecutive days on and 14 days off occurring every 56 days.
Procedures prior to initial study treatment (<14 Days) are: Neurological/Oncological History, Neurological Examination, Height, Weight, and Body Surface Area, Performance Status, Quality Of Life FACT-BR, Labs, MGMT tissue analysis, and Cranial CT/MRI with and without contrast.
The same procedures are repeated on Day 1 of each treatment cycle with the addition of an adverse event assessment. And the off study procedures for patients are performance status, Quality Of Life FACT-BR, MGMT tissue analysis, and cranial CT/MRI with and without contrast.
Patients may continue with each temodar daily dose therapy if clinical and neuroradiographical exams are stable or improving.
Detailed description
A single arm Phase 2 trial with the study drug temozolomide (temodar) for newly diagnosed glioblastoma in elderly patients (defined as greater than or equal to 70 years old). Temozolomide will be administered orally (a capsule) at approximately the same time daily (bedtime) for 42 days on and then 14 days off; cycles may be repeated every 56 days. Complete blood counts will be obtained bi-weekly, evaluations monthly and MRI's every 2 months after a cycle of therapy.
Procedures prior to initial study treatment (<14 Days) are: Neurological/Oncological History, Neurological Examination, Height, Weight, and Body Surface Area, Performance Status, Quality Of Life FACT-BR, Labs, MGMT tissue analysis, and Cranial CT/MRI with and without contrast (all disease found at staging must be followed using the same modality used at Pre-treatment. Tumor assessments are to be repeated every 56 days thereafter until progression). The same procedures are repeated on Day 1 of each treatment cycle with the addition of an adverse event assessment.
Patients may continue on therapy unless one of the following occurs:
- Documented or clinical progressive disease at any time
- Unacceptable toxicity
- Treatment delay of > 2 weeks for any reason
- Study data or other data indicate that the study treatment is not beneficial for the patients; defined as at least one response in the first 12 patients within each tumor histology strata
- Non-compliance by the patient with protocol requirements (follow-up, treatment, administration of disallowed therapy)
- Changes in medical status of the patient such that the patient no longer meets eligibility requirements (leptomeningeal spread, change in mental competency) or the investigator believes that patient safety will be compromised.
- Patient withdrawal of consent for treatment
- Occurrence of one toxic death
Patients with CR, PR, or stable disease (SD) will be treated for a minimum of 3 cycles [6 months] or until disease progression. For patients responding to treatment, continuation of therapy beyond 3 cycles is at the discretion of the investigator. Response parameters will include the MacDonald criteria for evaluating brain tumors. Response is measured by a reduction in tumor size.
After cessation of protocol therapy, patients will continue to be followed for survival at 2-month intervals for up to three years from start of treatment. And the off study procedures for patients are performance status, Quality Of Life FACT-BR, MGMT tissue analysis, and cranial CT/MRI with and without contrast.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Temozolomide |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- Patients must have histological documented glioblastoma or gliosarcoma. All patients must have had prior pathologic confirmation of tumor histology.
- Patients must be > than or equal to 70 years old.
- Patients must have a Karnofsky performance status of > 50.
- Nonmeasurable disease or measurable disease per MacDonald criteria
- Patients must have a predicted life expectancy of at least 12 weeks.
Key exclusion criteria (12 listed)
- Patients have evidence of leptomeningeal spread of disease.
- Patients having been treated with prior chemotherapy or radiotherapy.
- Patients with a second active malignancy or diagnosis of other cancer within -3 years of enrollment, except for surgically cured basal cell carcinoma, or in situ carcinoma of the cervix.
- Mentally incapacitated patients or psychiatric illness that would prevent the patient from giving informed consent.
- Patients with poorly controlled diabetes, hepatitis infection, uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, and myocardial infarction within the previous six months, or serious uncontrolled cardiac arrhythmia.
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: Temodartemozolomide 75 mg/m2 /d | Drug | 1 |
Primary outcome
Evaluate overall survival
Time frame: dependent upon results
4 secondary outcomes
Progression-free survival at six and nine months
Time frame: 9 months
Response rate measured by a reduction in tumor size
Time frame: 9 months
Frequency and severity of adverse events
Time frame: 9 months
Quality of life measured at each cycle utilizing the QOL FACT-BR
Time frame: 9 months
Results and safety
The study was stopped early (reason given: IRB Study Closure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2009.
- Moffitt Cancer Center Clinical Trials WebsiteLink 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.
Marc Chamberlain, MD principal investigator
H. Lee Moffitt Cancer Center and Research Institute
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 Glioblastoma and Gliosarcoma, run by H. Lee Moffitt Cancer Center and Research Institute 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 11 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: stopped early, as of the sponsor's last update on 22 Jan 2009. 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 was stopped early (reason given: IRB Study Closure). Results are not available in the source record.
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?
Evaluate overall survival (time frame: dependent upon results). 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 22 Jan 2009.